"Sleep and Pregnancy" Francesca L Facco (02.17.2021)

March 01, 2021

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00:13Why don't I just start?
00:16I think people are spilling in from
00:19faculty meeting as I mentioned.
00:22I just want to welcome you today
00:24to the Yale Sleep Seminar.
00:26I just have a few announcements
00:28before I introduce our speaker today.
00:30First, everyone please make
00:32sure to mute yourself.
00:33Secondly, in order to receive CME credit,
00:36you're going to check the chat box
00:38or the chat room for instructions.
00:40You can text the unique ID for this
00:44conference until 3:15 PM and you
00:46have to register with the LC ME
00:48before you before you can do this.
00:51If you have any questions during
00:53the presentation,
00:54please just write in the chat box.
00:56I'm at the end if we have some time,
00:59we can go through that recorded
01:01versions of these lectures will be
01:03available online within two weeks
01:04at the link provided in the chat.
01:06And finally,
01:07please feel free to share any of these
01:09announcements for the weekly lecture
01:12series to anyone who's interested in
01:14give Debbie Lovejoy the email contact.
01:16So I also want to make a couple
01:18of specific announcements.
01:20One to let you know that the sleep
01:22seminar next week is next week,
01:24February 24th.
01:25I'm sorry the sleep someone are
01:27neck is not going to happen next
01:29week on February 24th because
01:31of this sectional retreat.
01:32And it's also not going to happen on
01:35March 3rd the following week because of
01:37the Connecticut Plumbers Society meeting.
01:39So the next time we meet will
01:41be March 10th when we do our
01:44joint Yale Harvard Conference.
01:45That's going to be held by Doctor Up.
01:48How much to see?
01:49Who's a Sleep Medicine?
01:51Felons going to speak about the
01:53COPD Orsay overlap syndrome.
01:55So with that it's my great pleasure
01:57pleasure to introduce our today's speaker,
02:00doctor,
02:00faculty,
02:01Doctor Fakel completing her medical
02:03training at Georgetown and then
02:05spent several years at Northwestern
02:07where she completed her residency
02:09in OBGYN and have fellowship and
02:11maternal fetal medicine as well
02:13as well as a Masters of Science
02:15and clinical investigation.
02:17And I see that that you published
02:20with Doctor Phil's nice,
02:22so I'm assuming that's where your contact.
02:25This nature since 2011,
02:26she has been at the University
02:28of Pittsburgh where she is now
02:30an associate professor in the
02:32Department of Obstetrics,
02:33Gynecology and Women's Health in the
02:35division of Maternal Fetal Medicine.
02:38Doctor Factless Research is instrumental
02:39in advancing our knowledge in the
02:42nature of sleep during pregnancy.
02:43She is a Co investigator in the
02:46Multi center new mom to be study
02:48and as I was just telling her,
02:51we're very excited about her research
02:53because it's gonna really impact.
02:56Our guidelines or clinical care
02:58of patients in the future,
03:00particularly sleep disordered
03:01breathing and and perinatal outcomes.
03:03She has authored numerous peer reviewed
03:05publications on this topic and she
03:07said well celebrated against sorry.
03:09Active clinical educator as well as
03:11recipient of many research awards,
03:13academic Rewards Education Awards.
03:15She's got the trifecta in place.
03:17So without further ado,
03:19I'd like to let Doctor Fackler
03:21start host her talk.
03:23Thank you. Well, thank you
03:24so much for that. Very kind
03:27introduction and I'm happy to be here.
03:30Kind of sharing some of my work in the
03:34work of others in the arena of sleep,
03:38health and the topic of
03:40my presentation is sleep.
03:42Health of question.
03:43Is it a modifiable risk factor
03:45for adverse pregnancy outcomes?
03:48And as you mentioned,
03:49I got started in this work at
03:52Northwestern through kind of
03:54collaboration with Doctor Phil.
03:56A see who.
03:57That was part of my mentor ship team.
04:00As a fellow and through that
04:02kind of initial work,
04:04I've been very fortunate to be
04:06involved in a lot of multi center.
04:09Studies that have kind of led
04:12to publications and expansion
04:13of the data in this arena,
04:15so I'm very excited to share some
04:18of this work with you today.
04:20I don't have any conflicts of
04:22interest and I always like to start my
04:25slide with my favorite sneak quote,
04:27which is from a researcher,
04:29Doctor Alan Rahxephon.
04:30If sleep does not serve an
04:33absolutely vital function that is
04:35the biggest mistake the evolutionary
04:37process has ever made.
04:39So my outline for today we're going
04:41to start by kind of just reviewing
04:44sleep disruption and its potential
04:46linked to adverse pregnancy outcomes.
04:48Focusing on the question of is
04:51there biologic plausibility?
04:53And then I'm going to review
04:55studies that have given us some
04:58good objective data on sleep,
05:00destruction and pregnancy,
05:01as well as the link of that sleep
05:04disruption has an adverse pregnancy outcomes,
05:07principally reviewing today.
05:08The link to just stational diabetes,
05:11hypertension and create clamp
05:13Sia and Preacher in Burg.
05:16And then we'll end with the question
05:18that I posed at the beginning.
05:21Is sleep disruption a modifiable
05:23respecter for adverse pregnancy
05:25outcomes will review some of kind of
05:27the literature out there on sleep
05:29interventions and focus on a CPAP
05:31trial that is currently recruiting.
05:34So when we think of sleep and its
05:37potential role in health in general,
05:40we think of how you know.
05:43We know that sleep disruption
05:45can come in a variety of forms.
05:48It can come in short and sleep duration.
05:52Sleep fragmentation,
05:53circadian disruption,
05:54or,
05:55in the case of some Fabian specifically
05:59nocturnal hypoxemia or nocturnal
06:01intrathoracic pressure swings,
06:04and that these derangements and sleep
06:07have been linked to the following
06:11derangements in our taxes, theology.
06:14Dysregulation of adipocyte kinds.
06:16Activation of the HPA access.
06:21Surges of cortisol that are
06:23generally in this time with our
06:25circadian rhythms and increase in
06:28sympathetic activity at night and
06:30as well as oxidative stress and
06:33inflammation and outside of pregnancy.
06:35There has been a lot of research
06:37out of slinkies sleep disruptions.
06:40These alterations in pathophysiology
06:42and hypertension,
06:42cardiac disease and diabetes,
06:44and what my interest was when
06:47I started in fellowship at was
06:50to understand how.
06:51Sleep through similar mechanisms can
06:54potentially influence pregnancy outcomes
06:56and kind of when we think about it,
06:59we know that a pregnant woman
07:02can come into pregnancy with
07:04sleep disruptions that preexist
07:06they could have issues with
07:08insomnia or sleep duration,
07:10sleep fragmentation.
07:11They could have pre existing sleep apnea.
07:15However, we also know that pregnancy in
07:18and of itself predisposes to sleep changes.
07:22And these sleep changes can lead to
07:24more disturbed sleep on top of any pre
07:27existing issues they can in introduce
07:30new sleep problems and certainly
07:33for sleep disordered breathing.
07:35I'll show you data that there is an
07:37increase in sleep disordered breathing
07:40as pregnancy progresses due to the
07:43pathophysiologic changes associated
07:44with normal weight gain in pregnancy
07:47and plasma volume expansion and edema.
07:49So we have that women can enter
07:52pregnancy with sleep problems or
07:54can develop sleep problems because
07:56of the changes of pregnancy.
07:58And we know that those we problems have
08:00been linked to those pathways that I
08:03mentioned earlier and what pregnancy
08:05researchers know is that those very
08:07same pathways have been linked to
08:09metabolic dysfunction in pregnancy
08:10as well as endothelial abnormalities
08:12in pregnancy and those have been
08:14linked to adverse pregnancy outcomes.
08:16So there is a lot of biological plausibility
08:18and interest in understanding the role of.
08:21Sleep in pregnancy health.
08:24And when we think of sleep in
08:26pregnancy or do an Internet search,
08:28we often come across kind of
08:30pictures like this.
08:31But what those of us who practice
08:33either in the pregnancy world or
08:35in the sleep world know that it's
08:38often not quite a prettier picture
08:40and that sleep problems are a real
08:42clinical issue for our pregnant moms,
08:44and it's for a variety of reasons.
08:47As I mentioned earlier,
08:48you can either come into pregnancy
08:50with previous pre existing problem
08:52that gets exacerbated or you can
08:54develop a new problem.
08:55Whether that be sleep apnea that can
08:58disrupt your sleep but also other
09:01things like back pain and the increase
09:04in reflex disease as well as the
09:07increased need to wake up and urinate
09:10at night can all disrupt sleep.
09:13For a pregnant woman,
09:14we know that restless leg syndrome
09:17symptoms are increased as pregnancy
09:19progressives and that can lead
09:21to sleep disruption.
09:23And we also know that the hormonal
09:26changes that occur in pregnancy can.
09:29Ultra Moudan can alter other CNS
09:32functions that can ultimately
09:34lead to disrupt disrupted sleep.
09:39What I'm going to review now is
09:41what was alluded to earlier than
09:43you Mom to be pregnancy cohort.
09:45I'm going to present a lot of data
09:47from the new mom to be cohort,
09:49so I thought I would spend just a
09:51second reviewing with this cohort
09:52was and what kind of sleep data
09:55was collected from this cohort.
09:56So then you want to be stands
09:59for Nulliparous pregnancy.
10:00Outcomes study monitoring mothers
10:02to be and it was a cohort of 10,000.
10:05The liparus women meaning first time
10:07moms who were followed prospectively
10:09in pregnancy and the visit times
10:12in pregnancy are outlined here
10:14visit one was conducted between
10:15six weeks and 13 weeks and six days
10:18visit to between 16 and 21 weeks
10:21and six days and visit 3 between
10:2422 weeks and 29 weeks and six days.
10:27So I'll be referring to these kind of early.
10:30Mid and late pregnancy visits throughout
10:34the slides represent the data.
10:37Sleep data was collected in various ways.
10:39There was subjective sleep data in
10:41the form of sleep surveys that was
10:44collected at visit one and visit
10:463 on all participants.
10:48There was objective sleep data
10:49that was collected on a subset of
10:52participants at visit one and visit
10:543A subgroup of women completed home
10:56sleep testing for sleep disordered
10:58breathing assessment and our sample
11:00size for that was about 3600 women.
11:03Add visit to a subgroup of women
11:06completed seven days of Actigraphy,
11:08along with a sleep log and the
11:11sample size for them to.
11:13This analysis was around 780 women.
11:20Middle review first.
11:21The data on that actigraphy subset,
11:23so it's called the new mom to be sleep
11:26duration and continuity side study.
11:28And as I mentioned,
11:29it was conducted at visit 2 where women
11:32were sent home to wear an actigraph
11:35and act to watch and complete asleep.
11:39Survey athlete blog.
11:40And like I said about 780
11:43women completed this study.
11:45And here are sleep characteristics
11:48from that subgroup that I'm in bed
11:52for this subgroup was 8.7 hours,
11:54and in this slide I also showed
11:58the standard deviations here
12:00sleep duration with 7.4 hours.
12:03Wake after sleep onset was 42 minutes.
12:06Sleep midpoint for the group as
12:08a whole was 3:38 AM and 27.9%
12:11of women had a sleep duration
12:13of less than 7 hours per night.
12:16Typically kind of what is used
12:19to define a short situation.
12:212.6% of women had asleep ship for
12:24duration of greater than 9 hours.
12:27And this is just the distribution
12:29of the sleep duration,
12:31just to kind of show where
12:33it lies and it mimics it.
12:36Mirrors,
12:36I should say what we see in
12:39non pregnant populations where
12:40there is about a 20 to 30%.
12:46Incidents of short sleep duration.
12:51Um, regarding our sleep timing data,
12:53we found that 18.9% of women had a sleep
12:56midpoint that was later than 5:00 AM.
12:58So these are people that are
13:01considered to have late sleep timing.
13:04What we found was that women who
13:06reported working regular day shifts
13:08tended to have earlier sleep midpoints
13:10and that the women that really had
13:13the later sleep midpoints were women
13:15who reported some form of shift work
13:17but also unemployed individuals.
13:20Those are the individuals that tended
13:22to have more later sleep timing.
13:27Here are some other data that we
13:29got from this cohort regarding the
13:31sleep in pregnancy and demographics.
13:34Regarding race and ethnicity,
13:35we found that non Hispanic,
13:37black and Asian women had
13:39the shortest sleep duration.
13:41And non Hispanic black women
13:43also had the worst sleep,
13:44continuity and the latest sleep midpoint.
13:48Regarding age,
13:49we found that younger women had
13:51the highest wake after sleep onset.
13:54The lowest sleep efficiency,
13:55the latest sleep midpoint,
13:57and the most variable sleep.
14:00And regarding BMI,
14:01we found that women with a BMI
14:04of greater than or equal to 30
14:06had high sleep fragmentation,
14:08low sleep efficiency,
14:09and long way after sleep onset.
14:11While sleep duration was
14:12not associated with BMI,
14:14obese women had a medium sleep
14:16duration that was 36 minutes
14:17less than the lowest BMI group.
14:22And we took all this objective data
14:24on sleep duration and sleep timing
14:26and then looked at associations with
14:28average pregnancy outcomes and what
14:30we found was a strong Association
14:32between both sleep duration and sleep
14:34timing and just stational diabetes.
14:36So this is our.
14:39Data on short sleep duration defined as
14:42a sleep duration of less than 7 hours.
14:46And just stational diabetes risk.
14:47And as you can see in the blue bar
14:50are women with the sleep duration
14:52of less than 7 hours.
14:54The red bar greater than or equal to 7 hours,
14:57and women who had short sleep
14:59durations had about two fold increase
15:01in the rate of gestational diabetes.
15:05And this was our late sleep midpoint data,
15:08which was defined as a sleep
15:10midpoint of greater than 5:00 AM.
15:12And this group also had significantly
15:15higher rates of gestational diabetes.
15:16As you can see in the blue
15:19bar late sleep midpoint.
15:21Participants had eight point,
15:231% rate of gestational diabetes
15:26versus individuals who sleep midpoint
15:29preceded 5:00 AM was three point,
15:313% rate of gestational diabetes.
15:36And this is a kind of table from our paper.
15:40I'm not going to go through all of the data,
15:45but given our sample size and the
15:47rates of gestational diabetes,
15:49we weren't able to perform adjusted
15:51analysis that grouped kind of all of our
15:55known covariates demographic covariates,
15:57but we were able to look at kind of
16:00individual adjustments and what we
16:02found is when we adjusted for age BMI.
16:06Race, race, ethnicity as well as
16:09frequent soaring or employment
16:11categories that are odds ratios affect
16:14sizes for just stational diabetes in
16:17both the sleep duration and the sleep
16:21midpoint analysis remained consistent.
16:26I'm going to step away just from
16:28the Newmont to be data to kind of.
16:31Define this discussion on sleep
16:33duration and just stational diabetes
16:36to show you some other research.
16:38'cause the question comes up OK.
16:40Well sleep you've shown us that sleep is a
16:43risk factor for just stational diabetes.
16:46But then what happens once a woman
16:48gets just stational diabetes?
16:50What is what role does risk this
16:52League play in their glycemic profile?
16:55And so this was a study where we
16:57recruited women who were very newly
17:00diagnosed with gestational diabetes
17:01and ask them where in actigraph and
17:04record their blood glucose values
17:06and what we do in our practice.
17:09As we meet women,
17:10do uniform teaching on dietary changes
17:12to help control blood glucose.
17:14Have them do a week of dietary modification,
17:17and then after that very uniform education,
17:20bring them back in to meet with a
17:23physician to decide if they need
17:25medical management with insulin
17:27to control their blood sugars on
17:30top of their dietary changes.
17:32And So what we did is we study women
17:34in that one week period from education
17:37and initiation of dietary changes to
17:39their physician visit and ask them to
17:42wear the actigraph during that time.
17:44And in that time period,
17:45when they were asked to do diet
17:47modifications to see what their
17:49blood sugar values would look like,
17:51we found that shorter sleep duration was
17:53associated with worse glucose control
17:55in women with just stational diabetes.
17:57And we found that there was a 2 to
17:596 milligrams per deciliter increase
18:01in glucose observed.
18:03For every hour or less of sleep.
18:06And this is an effect size similar
18:08to what we would see in starting
18:10someone on a low dose of Libra Raiden,
18:13pregnancy or low dose of insulin
18:15in pregnancy.
18:16So certainly sleep has a role in potentially
18:18achieving a glycemic control in women,
18:21which is stational diabetes.
18:25Moving on, I'm going to kind of now cover
18:29some data on sleep and preterm birth.
18:32People often ask me,
18:34is there a link between sleep and
18:37preterm birth and the data here is
18:40still kind of continuing to emerge.
18:43I showing here a study that was
18:46a California database study that
18:49compared women without a recorded
18:52sleep disorder diagnosis in the chart.
18:54Two women with an insomnia diagnosis
18:56and they found that women with
18:58insomnia had a nearly two fold
19:00higher risk of early preterm birth,
19:03defined as less than 34
19:05weeks gestation at delivery.
19:07And the adjusted odds ratio is shown here.
19:10So while not directly measuring sleep
19:13duration or objectively measuring sleep,
19:15it's showing that women with
19:17kind of sleep disorder,
19:18diagnosis in their chart seem to be
19:22at increased risk for preterm birth.
19:25So now will take us back to the new mom
19:28to be cohort to see what data has been.
19:31Has come from that regarding pre term birth.
19:34I'm going to take you now to
19:36the sleep survey data.
19:38The Sleep survey data again
19:40to remind everyone a curd and
19:42visit one and visit three.
19:44It was given to all of the women
19:47who enrolled in new mom to be.
19:49But after some cleanup of the
19:51data to make sure that all of the
19:54entries were valid and complete,
19:56we ended up with about 75 to 7600
19:58women with complete survey data.
20:00At visit one and visit three respectively.
20:06So what did the sleep survey data show us?
20:09Well,
20:09it showed us that short sleep
20:11duration was present at 17% of our
20:13participants at visit one and at the
20:15rate of short sleep duration went up
20:18to 20% of participants at visit 3.
20:21And that late sleep timing and sleep
20:24timing of greater midpoint of greater
20:26than 5:00 AM was present in 11.6%
20:29of visit one and stay pretty much
20:32stable at 12 point 2% at visit 3.
20:37And what we found regarding pre
20:40term birth in this cohort is that
20:42lately midpoint greater than 5:00 AM
20:45was associated with pre term birth.
20:48The rate in women with a late sleep
20:51midpoint was 9.5% and when we looked
20:54at women without a sleep lately
20:57midpoint the rate was 6.9% and that
21:00the Association was and remains
21:02statistically significant after adjustment
21:04for all of the important covariates.
21:06We looked at our visit to our
21:08objective data from Actigraphy,
21:10which was a smaller,
21:12obviously a smaller subgroup
21:13about this 10th of the size of
21:16the data collected by surveys.
21:18But we also found similar trends in preterm
21:20birth rates by sweet midpoint status,
21:23but because of the smaller
21:24sample size and the low rate of
21:27overall rate of preterm birth,
21:29we did not demonstrate statistical
21:31significance in the actigraphy data,
21:33but in, but importantly showed,
21:34a very similar.
21:37Effect size and direction of the effect.
21:39We did not find any relationship
21:42in this cohort either by the Sleep
21:44survey data or in looking at the
21:47visit to objective data between
21:49self reported or objective sleep
21:51duration and pre term birth.
21:57You get that kind of now shift over to talk
22:02about the new mom to be study and its sub.
22:07Sub study on sleep disordered breathing.
22:10So as I mentioned at the very beginning
22:13when I described this study about 3500,
22:16women underwent objective sleep assessments
22:19for sleep disordered breathing and at both
22:23the early visit one and the late visit,
22:25three time points, and we use the
22:30embedded device for this study.
22:33And here is our data regarding the prevalence
22:36of sleep disordered breathing defined
22:37as an age I of greater than or equal to
22:41five in this cohort of nulliparous women
22:43in this slide I'm showing the rates in
22:46the early pregnancy visit one in orange
22:49and in mid pregnancy visit 3IN blue.
22:52And as you can see,
22:54the rate of sleep apnea increases
22:56from early to mid pregnancy.
22:59Also, what you can see is the vast
23:02majority of sleep apnea in pregnancy
23:04is mild sleep apnea with an age I
23:07between 5:00 and less than 15 and
23:10that moderate to severe sleep apnea.
23:12Remains rare in pregnancy,
23:14even in late pregnancy with only one point,
23:182% of women in late pregnancy at visit,
23:213 having moderate to severe sleep apnea.
23:26So in summary,
23:27what we found is that in early pregnancy
23:30the rate of sleep apnea was 3.6%,
23:33but as we anticipate given the pregnancy,
23:36associated changes that might
23:38increase sleep apnea,
23:39that in fact we do see an increase
23:42in objectively measured sleep apnea
23:44in pregnancy with eight point,
23:463% prevalence in mid pregnancy.
23:48What we learned from this study is
23:51also that snores women with self
23:53reported frequent snoring and women.
23:56With obesity going into pregnancy,
23:58a BMI of greater than or equal to
24:0030 had the highest rates of sleep
24:03apnea at about 20% in the mid
24:06pregnancy time point assessment.
24:11So now we looked at our data
24:14and looked at rates of.
24:17Metabolic issues just stational
24:18diabetes and hypertensive issues in
24:21pregnancy and what I'm showing here
24:23is our data on gestational diabetes
24:25by sleep disordered breathing status.
24:28On the left hand side is the early
24:31pregnancy data on the right hand
24:33side is the mid pregnancy data.
24:35The blue bars are women without sleep apnea,
24:38and the yellow bars are women with
24:41sleep apnea and this is just stational
24:44diabetes rates in the two groups.
24:46And as you can see,
24:48the rate of gestational diabetes was
24:50significantly higher in women with
24:52sleep apnea and the adjusted odds ratios
24:54here remains statistically significant.
24:56After we adjusted for age.
24:59BMI and presence of met
25:03other medical comorbidities.
25:09And this is our data on the rates of
25:12preeclampsia in this group of women,
25:14and again, as you can see by the yellow bars,
25:17the women with sleep apnea had
25:20higher rates of preeclampsia compared
25:22to women without a sleep apnea.
25:24And again, adjusted odds ratios
25:27remained statistically significant.
25:31I'm gonna take a little break now from
25:34the new mom to be data to share some
25:37other data from some other researchers
25:39that have looked at sleep disordered
25:42breathing and kind of specifically again,
25:45asking the question.
25:46OK, well, we know it increases
25:48the risk of gestational diabetes,
25:50but what about after they have gotten that
25:53diagnosis and just stational diabetes?
25:55Is there any Association with
25:57sleep disordered breathing and
25:59worsening glycemic control?
26:00And what they found here in this study
26:03where they hit took 65 participants with
26:05just stational diabetes and sleep apnea.
26:07And they had them undergo
26:09continuous glucose monitoring.
26:10And as you can see,
26:12the women with the highest age eyes
26:14with shown in the red bars up top.
26:17Those with the age eyes of
26:20greater than or equal to 30.
26:22They had the highest nocturnal
26:25and morning levels of glucose,
26:27so an Association here in
26:30this small study with Ahi,
26:32an worsening lexemic control.
26:38Would it take a few minutes now I'm kind of
26:42to cover some other sleep related questions
26:45that come up in in talking about pregnancy.
26:49One is the sleep position controversy.
26:53So it's been kind of common for women to get
26:57advice about how to sleep during pregnancy,
27:00especially after 20 weeks gestation.
27:02And if you search,
27:04sleep or sleep positions in pregnancy,
27:06you'll often find pictures like the
27:09one here where it's like 7 best or
27:13seven safe positions to sleep in.
27:16And the reason for this is
27:18kind of through the years.
27:20Women have been discouraged from
27:22sleeping on their back or on their
27:24right side because it was thought
27:26that sleeping on your back or on
27:29the right side would lead to more
27:31cable cable compression that can.
27:34Alter blood flow to the.
27:39Uterus and decrease blood flow to the
27:42uterus has been postulated as potentially
27:44a risk for adverse pregnancy outcomes.
27:51Um so.
27:55And there's been a lot of interest in this,
27:58because obviously seek position
27:59is potentially modifiable,
28:00so there's been a lot of interest in
28:02giving campaigns to tell women to sleep
28:04on their sides or sleep on their back.
28:07But this, instead of sleeping on their back
28:09and specifically favoring the left side,
28:11if they can over the right side.
28:13But obviously this leads to
28:14a lot of maternal anxiety,
28:15'cause you get questions about.
28:17Well, what if I wake up and
28:19I'm sleeping on my back?
28:20Is that bad?
28:21Or do I need to use pillows
28:23and prompts to avoid?
28:24Kind of rolling on to my back and
28:27she's been a lot of anxiety about this.
28:29And you know when we look at the sleep
28:32position data and pregnancy outcomes
28:34which we have to recognize is that
28:37the prior studies have included small
28:39numbers of women and importantly,
28:42the interviews regarding maternal
28:43sleep were conducted after a
28:45still birth or another adverse of
28:47pregnancy outcome of the Kurds.
28:49So especially in the still birth literature,
28:52that's usually like case control
28:54studies where they take cases of
28:56stillbirths and compare it to kind
28:58of controls without stillbirths.
29:00And they ask women about their
29:02sleep position.
29:03And have come up with kind of some
29:06Association with sleeping on your back or.
29:09Left on the right side and
29:11adverse pregnancy outcomes.
29:12But by conducting studies in this way,
29:15we all know that it introduces the
29:18potential for considerable recall bias.
29:20So what was nice about the new mom
29:22to be data is that we actually
29:25had collected sleep position data
29:27prospectively in this cohort,
29:29both with the Sleep survey data and
29:31also in the subgroup that did sleep
29:34disordered breathing assessments.
29:35The embedded device recorded sleep
29:37position during the night that
29:39they were the sleep apnea monitor.
29:41So this was prospectively collected
29:43data and visit one and visit three.
29:45And what we found was in the survey
29:48data that going to sleep in the
29:51supine or right lateral.
29:52Position was not associated with
29:54an increased risk of composite
29:56outcome of stillbirths.
29:58Small Burgess Stational
29:59age newborn gestation.
30:00Hypertensive disorders compared to
30:02going to sleep within the quote.
30:04Ideal position,
30:05which is what has traditionally been
30:07considered. The left lateral position.
30:09And the null finding was also shown
30:12using the objective data on sleep
30:14position in the subgroup of women in
30:16the sleep disordered breathing substudy.
30:19So even though it was smaller
30:21and less powered,
30:22that's that objective data confirmed to
30:24what we were seeing in the survey data,
30:26which was no Association between
30:28sleep position and this composite
30:30of adverse pregnancy outcomes so.
30:32It's not kind of a definitive, I think.
30:35Nail on the coffin on this question
30:36on sleep position and pregnancy,
30:38but certainly data to reassure our
30:40pregnant women who come to us with
30:42these questions about sleep position or
30:44waking up in the middle of the night,
30:46or having anxiety of not being
30:47able to sleep in,
30:49quote unquote the right position at night.
30:54I'm gonna just say a word on
30:56restless leg syndrome and periodic
30:58limb movements in sleep because I
31:00think not doing asleep talk without
31:03addressing this important issue.
31:04Asleep talking pregnancy without
31:06addressing it would not be correct,
31:08but I will also say that I'm not an
31:11expert in this area and has not been kind
31:14of an area of ongoing research for me,
31:18but other researchers have been
31:19very interested in RLS or periodic
31:21limb movements in pregnancy because
31:23we know that during pregnancy.
31:25The rates of these disorders
31:27do increase during pregnancy.
31:29About 20% of women experience
31:31these symptoms compared to two
31:33to 10% of the general population.
31:35The symptoms seem to peak in
31:37the 3rd trimester,
31:38but often can resolve around
31:40delivery and studies have shown
31:42that women with just stational RLS
31:44are at increased risk of difficulty
31:46initiating and maintaining sleep.
31:48They are at increased risk of poor
31:50sleep quality for daytime function
31:52and excessive daytime sleepiness
31:54compared to pregnant women without RLS.
31:56And there's also data showing a
31:59potential link between our less
32:00or periodic PMS.
32:01Two adverse pregnancy outcomes,
32:03and I'm not going to review all that
32:06data here because of time issues,
32:08but I kind of this is a good review that
32:11I have come across and have used that.
32:14I've provided the reference here for.
32:19And then I want to before I move into
32:21kind of the second half of my talk,
32:24I just want to mention also
32:26sleep and maternal mental health.
32:27This is a huge.
32:30Area of research into clinical
32:32relevance to our pregnant women.
32:34It's a whole lecture on its own.
32:37We recognize that there's a bidirectional
32:39relationship between sleep and mental
32:41health issues like anxiety and depression,
32:43and that in pregnancy.
32:45Mental health issues can often
32:47be exacerbated or new onset.
32:49Also in the postpartum period,
32:51which presents its whole unique sleep,
32:53challenges relating to caring for a newborn.
32:56So this is a super interesting
32:59area of research other.
33:00Researchers in pregnancy and also
33:03sleep have focused on this and
33:05just want to make sure that we
33:08recognize this as an important
33:10area in sleep and pregnancy.
33:14Research.
33:17Alright, and so now kind of the second
33:20half of my talk is going to focus on the
33:23question I posed at the very beginning,
33:26which was is sleep healthy?
33:28Modifiable risk factor for
33:29adverse pregnancy outcomes?
33:30So I showed you kind of the data
33:33suggesting that sleep disruption
33:34is a real issue in our pregnant
33:37women that pregnant women have.
33:39Significant rates of short sleep duration
33:42of circadian disruption with later sleep,
33:45tight time timing and that pregnancy
33:47increases the rate of sleep apnea,
33:50especially in our most at risk,
33:53individuals frequent snores
33:54and individuals with obesity.
33:56So what do we know, though,
33:59from these Association studies?
34:02In terms of can we modify the?
34:07The Sleep risk factor an improved
34:11pregnancy outcomes.
34:12And the issue is what that we don't know.
34:15We don't have a lot of data regarding
34:18interventions in pregnancy that
34:20have addressed sleep and how they
34:22could impact maternal health.
34:24The majority of studies that have
34:27looked at sleep interventions
34:28are small pilot trials.
34:30And the outcomes are typically
34:32focused on subjective sleep symptoms,
34:33as now common.
34:35Some have addressed maternal mood.
34:37As outcomes,
34:38this is a good systematic review
34:40that was published in 2020.
34:45In this review they looked and found 16
34:48studies of about 1250 expectant mothers.
34:52And they found that the studies evaluated
34:54the efficacy of various interventions
34:56such as cognitive behavioral therapy.
34:59Cite pharmacotherapy, acupuncture,
35:01mindfulness, and yoga,
35:03relaxation and herbal medications.
35:08Only six were randomized control trial and
35:12only four evaluated longitudinal outcomes.
35:15And they, the authors of this review,
35:17noted that there was preliminary
35:18support that was found for all the
35:21interventions that were studied,
35:22but that the knowledge is still too limited.
35:26At this point in time to really understand
35:29how sleep interventions can improve.
35:31Sleep in pregnancy and how this
35:33should translate to improved
35:35maternal is the outcomes.
35:37This is one of the largest trials
35:39that has been published on a
35:42sleep intervention in pregnancy.
35:44It was a study that was titled efficacy
35:46of a digital cognitive behavioral
35:48therapy for treatment of insomnia,
35:51symptoms and among pregnant women.
35:53It was one of the randomized control trials.
35:56It included 200 women who are randomized
35:59to either receive cognitive behavioral
36:01therapy or kind of usual care,
36:04and they found that women randomized.
36:07Received the digital Cognitive Behavioral
36:09therapy experience statistically significant.
36:10Greater improvements in insomnia
36:12symptom severity from baseline to
36:14post intervention compared to women
36:16randomized to receive standard treatments,
36:19so this is kind of a very important study,
36:22but again,
36:23kind of very focused on the maternal
36:26sleep symptom,
36:27which is a first step in understanding
36:30sleep as potentially modifiable for
36:32maternal fetal health and certainly helping
36:35women feel better in terms of insomnia.
36:38Symptoms and just the quality
36:40of the sleep is very important,
36:42but as a maternal fetal
36:44medicine physician and clinic,
36:46I'm also interested in kind of
36:48taking it to the next step.
36:52Which is understanding how potentially
36:54sleep interventions can improve
36:56pregnancy outcomes for women,
36:58and particularly given the associations
37:00we found which stational diabetes,
37:03preeclampsia and preterm birth
37:05could sleep interventions help
37:08reduce the rate of these outcomes.
37:12So one of the most interesting
37:14areas of research in this on this
37:17topic is sleep apnea.
37:18Because we know that sleep apnea
37:21has an effective treatment which is
37:23continuous positive airway pressure,
37:25and so we have this real opportunity
37:28in pregnancy to study of sleep apnea.
37:31Treatment can reduce the incidence
37:33of kind of complications such as
37:35hypertensive disorders or just
37:37stational diabetes.
37:40CPAP trials in non primary cohorts and
37:42I don't have to tell this audience
37:45here because I'm sure you know I
37:48speak to both pregnancy audience,
37:51pregnancy centered audience
37:52and sleep centered audiences.
37:53But obviously you know this group knows
37:56that what we know from CPAP trials and
38:00non pregnant cohorts is that it works.
38:03It normalizes the HI and that very
38:05clearly is shown improved sleep quality
38:08in daytime symptoms in individuals who.
38:11Have become compliant on their see PAP.
38:14There's also some signal that CPAP may
38:17improve cardiovascular outcomes in non
38:20pregnant cohorts and this is one of the
38:22biggest trials regarding this which
38:24is a trial by Barbara at all that.
38:28Look at OSA participants without Dasein
38:31sleepiness and they prescribe them CPAP
38:34compared to usual care and what they
38:37looked at was the follow up rates of
38:39hypertension of cardiovascular events.
38:41And on the left was their
38:44sample of the entire RCT,
38:46and while the curves looked
38:47a little different,
38:48it looks like the control group
38:50had higher rates of hypertension
38:52and cardiovascular events compared
38:54to the see PAP group.
38:56But the trend that they saw did
38:58not reach statistical significance
39:00when they did a subgroup analysis
39:02based on uses of usage of C Pap.
39:05However,
39:05they did find that individuals who
39:07were compliant with CPAP by definition
39:10of using it greater than or equal to.
39:124 hours per night.
39:14Did have a statistically significant
39:16reduction in the rate of hypertension
39:18or cardiovascular events at follow-up.
39:23The see PAP in pregnancy data is very
39:26very limited and I didn't pull up a
39:28lot of studies here because I will
39:31tell you the majority are case reports.
39:33For example, they'll have a women
39:35woman with preeclampsia in early
39:37pregnancy that they're trying to manage
39:40expectantly and not deliver because
39:41of her early just stational age,
39:43they'll find that she has sleep apnea.
39:46They'll put her on.
39:48You happen, they'll notice an
39:50improvement of blood pressure,
39:51and they'll write up that case, report,
39:54or kind of other smaller case series
39:56with very similar kind of outcomes
39:58that improved in blood pressure.
40:00In small groups of women.
40:03So we really don't know how CPAP
40:07can improve pregnancy outcomes.
40:09And this is despite the fact that
40:12actually pregnancy is an ideal scenario
40:14to better understand the role of
40:16CPAP as a preventative strategy to
40:19reduce cardiometabolic morbidity.
40:20If we think about outside of pregnancy,
40:23we know that in order to really
40:25study the see Pap's role in
40:27cardiovascular metabolic disease,
40:29we have to take individuals diagnosed
40:32him with sleep apnea and follow them
40:34for kind of years to see and look for
40:37the incidence of kind of diabetes.
40:40Or cardiovascular disease,
40:41and a lot of times some studies
40:44like the same study you know,
40:46because of the fact that you know
40:48you have to follow people for years
40:51to look at new onset hypertension or
40:53new onset diabetes or act or actually
40:56doing CPAP studies as secondary
40:58prevention taking individuals who
41:00already have underlying cardiovascular
41:01disease and using CPAP as kind of
41:04secondary prevention of like worsening
41:05of their cardiovascular status or a
41:07new event on top of their baseline.
41:10But in pregnancy,
41:11what's interesting is a woman can
41:13go from being completely,
41:15you know,
41:16euglycemic at the beginning of
41:17pregnancy and within nine months
41:19develop a real metabolic dysfunction
41:21that requires treatment with insulin.
41:23Similarly,
41:24a woman can go into pregnancy
41:26and be completely normal,
41:27tensive and developed by the
41:29end of their pregnancy.
41:31A very severe form of hypertension,
41:33such as severe preeclampsia that
41:35requires medical management and
41:37so given kind of the Physiology
41:39of normal pregnancy and.
41:40Adverse pregnancy outcomes.
41:42Studying sleep apnea in pregnancy and
41:45the role of CPAP is very exciting for
41:48me and I think exciting for the C,
41:51pap and sleep world in general
41:53because it really gives us an
41:55opportunity to understand C pap as
41:57kind of a preventative strategy for
42:00reducing cardiometabolic morbidity.
42:02So I'm going to bring you to kind of
42:05my last few sides which review a CPAP
42:07trial and pregnancy which is run by
42:10the maternal fetal medicine units.
42:12Networking is called with sleep
42:14trial and it's a multicenter RCT
42:16and yell is actually a site.
42:18I don't know if any of you here
42:20are aware of the study or have had
42:22patients that you have potentially
42:24interacted with were in our study,
42:27but yell is participating as a
42:29subsite of our Brown University,
42:30which is one of the.
42:33The central sites of the study.
42:35So pregnant individuals who have a BMI
42:37greater than or equal to 30 are actually
42:40identified to take home a home sleep
42:43test and to identify as either having
42:45sleep apnea by an HIV greater than or
42:48equal 5 or having a no sleep apnea.
42:51An women who are identified as
42:54sleep apnea positive are then.
42:56Recruited to be randomized into the
42:58RCT and the randomized control trials,
43:01it's the the two arms are the use
43:04of auto titrating CPAP or a sleep
43:07hygiene control or in kind of
43:09another way to say a usual care arm.
43:12Our primary hypothesis of this
43:14trial is the treatment of sleep
43:16apnea with CPAP in pregnancy will
43:18result in a reduction in the rate of
43:20hypertensive disorders of pregnancy.
43:25So why are we screaming individuals
43:27with a BMI of greater than equal
43:2930 and not all pregnant women?
43:31Well, we know from the Newmont to be
43:33data that actually this is kind of the
43:36highest risk group and it's an easy
43:38thing for us to ascertain and screen by.
43:41So from the new mom to be data,
43:44we knew that in the mid pregnancy
43:46assessment about 20% of individuals
43:48had an HIV greater than or equal to 5.
43:53In turning in terms of the timing of
43:55when we screen our women for this trial,
43:58when we kind of conceptualizes trial,
44:00we really talked a lot about the
44:02balance in terms of when to screen
44:04for sleep apnea and pregnancy.
44:06Obviously, the later you recruit,
44:08the more sleep apnea you will find as
44:10the changes weight gain, adima, etc.
44:12Of pregnancy will likely continue to increase
44:15the rate of preeclampsia in pregnant women.
44:18So you'll find more sleep apnea,
44:20but however fighting it really late
44:23really minimizes your ability to treat it
44:26in terms of getting people on the CPAP
44:28therapy and getting them comfortable
44:31and compliant with the therapy,
44:33and so the earlier you get women
44:35into the pipeline,
44:37the hopefully you'll have the highest
44:39amount of exposure to therapy,
44:41and probably the optimal treatment effect.
44:44So you have to balance these two
44:46things when you're thinking about.
44:49Screening and treating sleep apnea
44:51and pregnancy and then kind of
44:53having these discussions are group
44:55has decided to screen women and
44:58randomize them between 16 weeks and
45:0020 and 620 weeks 60s in gestation.
45:04We diagnose sleep apnea
45:06via a home sleep test,
45:09so we are using the apnea link shown
45:12here to diagnose sleep apnea and all of
45:15the acne links are downloaded an read
45:18by a centralized sleep reading center,
45:22so we all have centralized and quality
45:25control procedures for diagnosing RC Batman.
45:29We do have an exclusion for severe sleep
45:32apnea and for severe nocturnal hypoxemia,
45:34so women with an age I have greater
45:37than or equal to 30 or nocturnal
45:40hypoxemia as defined here are told
45:43that that is what the results of
45:45their sleep apnea test showed and
45:48then they are given local resources
45:51to see clinical care if they want to.
45:53It is anticipated an action we
45:56have found through the early phases
45:58of the study that this is rare.
46:01As I showed you in the new mom to be
46:03studying severe sleep apnea is rare in
46:06pregnancy and then this is anticipated
46:08to be less than 1% of our patient population.
46:12Here are two arms I mentioned
46:14that auto titrating CPAP rman.
46:16The sleep hygiene control
46:18and auto titrating CPAP farm.
46:19There given information about healthy sleep
46:22and then they are given AC pap machine,
46:25appropriate mask and a lot of
46:27education and follow up about CPAP use.
46:30They get weekly follow up in that
46:32group where we monitor compliance.
46:35In the Sleep Hygiene group,
46:37they get similar informational handouts
46:39about healthy sleep and also seek
46:42resources should they seek to too.
46:44Need to seek care for clinical
46:47issues and then they get monthly.
46:50Follow up through our study team.
46:52We do a lot of compliance monitoring.
46:55We are using the an app to help
46:58participants see their own CPAP
47:00compliance data and monitor their own
47:03progress and we also offer compliance
47:06incentives as part of this trial to
47:09help optimize C packing in our treatment arm.
47:14The primary outcome as I mentioned earlier,
47:17is hypertensive disorders of pregnancy,
47:19which is a composite of just
47:21stational hypertension, preeclampsia,
47:22superimposed pre clamp, Sia,
47:24HELLP syndrome, and eclampsia.
47:25But we are also very excited to look
47:28at some crucial secondary outcomes
47:30that include gestational diabetes,
47:32pre term birth and.
47:35The fetal fetal and neonatal outcomes,
47:37such as birth weight.
47:40I just put up here the local Contacts
47:44for the sleep trial at Yale as
47:47well as the main site at Brown.
47:51So if anyone is interested and learning
47:55more or getting more involved,
47:57locali referring a patient to be screened,
48:01we're happy to take your emails
48:05and get connected.
48:07And then this is my last slide
48:09and I thought I would just leave
48:12the last minute last 10 minutes
48:14for any questions or comments and
48:16I was just very happy to have
48:18this opportunity to present.
48:19So thank you very much.
48:24Thank you so much Doctor Fackeln,
48:25that was really a great and relevant talk.
48:29Yeah, as you mentioned the MFM you
48:32study being at yell alot of us here on
48:36the call I see part of the sleep center
48:40we actually do get the patients that I
48:43guess are excluded from this study which
48:46are the severe sleep apnea patients.
48:48An just speaking from my experience
48:51I definitely see severe sleep apnea
48:53an I get very very nervous, you know.
48:56And there's sort of this urgency to get them.
49:00You know, formally diagnosed and
49:02treated right away. Unfortunately just.
49:05You know are are just the way things
49:08work with insurance and all that.
49:11Often it is difficult.
49:12I wonder you know,
49:14as you had mentioned in all all your
49:17previous studies as well as other studies,
49:20the sleep apnea,
49:21the degree of sleep apnea.
49:23Often seeing these young otherwise
49:25healthy pregnant women are pretty mild,
49:27but is your feeling that it this
49:30mild group are also the mild disease
49:33is very impactful during pregnancy.
49:36And when?
49:36Or what data do we have to explore
49:39these other people who are presenting
49:41to the clinic who are just very severe?
49:44They may not be the majority of the
49:46pregnant women, but they're pretty scary.
49:47I must say, yeah,
49:49I will say first of all, thanks for
49:51the question about the mild disease.
49:53I mean, I'm always I always kind of
49:55going back to the new mom slide here.
49:58I'm always. You know?
50:00So impressed that you know the majority of
50:03these people had very mild sleep apnea,
50:06and Despite that it being very mild,
50:09the rates of their adverse
50:11outcomes compared to.
50:13To the non Seebacher group,
50:15even after adjustment for BMI
50:16and chronic hypertension,
50:17what significant here you can
50:19see odd ratios close to three
50:21for just stational hypertension
50:23and odds ratios close to two for
50:25preeclampsia so mild disease seems
50:27to be really relevant in pregnancy.
50:29In terms of that question
50:30about the severe preeclamptic.
50:32I mean, I think that's super interesting.
50:35They are very hard to gather into one
50:37cohort and study and look at their outcomes.
50:40I can only postulate that they probably have.
50:43Worse outcomes than women with
50:45mild disease and is kind of more
50:47urgent to evaluate and treat them.
50:49That was the reason our group
50:51decided to exclude women with an age.
50:53I have greater than or equal to
50:5530 from randomization.
50:56But what was interesting,
50:57your comment that you made about
50:59it's so hard to get women into
51:01treatment that's on the other hand,
51:03people were arguing we shouldn't exclude
51:05those women even though they only
51:07have a 50% chance of getting treatment,
51:09because getting treatment for them
51:11outside of pregnancy is really hard
51:12and 50% chance is better than 0.
51:15So was super interesting that we
51:17had kind of that, that discussion,
51:19and ultimately through the IRB,
51:21an R data safety monitoring Board.
51:23We made it an exclusion,
51:24but you're absolutely right,
51:26some people were like get them in
51:29the study 'cause at least they get a
51:3150% chance of treatment and really
51:33intense follow up through your protocol,
51:35but we you know we share that
51:38experience here of getting people
51:39into treatment and it centers like
51:42yours that really have helped.
51:44Our study,
51:45because it was crucial to develop
51:46collaborations with sleep specialist.
51:48So when we have a patient that
51:50screens out for severe sleep apnea
51:51that they're not felt to be kind
51:54of lost in the system,
51:55then we were able to get them
51:57links if they want to.
51:59You know,
51:59to get clinical treatment
52:00for their severe sleep apnea.
52:04So I'd like
52:05to ask a question. This is Mary.
52:13There I think you're frozen pregnant.
52:16Can you hear me? Yeah, I think you
52:20might have to repeat your question.
52:22Yeah, over the years I've seen a very
52:25large number of pregnant women with very
52:27severe sleep apnea. And the
52:31main concern that I have isn't
52:33sort of their acute Physiology,
52:35it's can they take care of the
52:37baby when they're discharged.
52:39Finally having given birth.
52:41And, and that's really the big
52:43challenge is getting them on
52:45treatment because many women
52:46don't have anybody to help them
52:48when they get home with the baby.
52:51And so that is that is, to me,
52:54an extremely important issue.
52:57I totally agree.
52:58I mean, I should also have put
53:00up a slide we know like I did
53:03for sleep and mental health.
53:05It's postpartum.
53:05Sleep is a lecture in and of itself,
53:08like how women cope with
53:10postpartum sleep disturbances,
53:11including sleep apnea,
53:12and also new onset disturbances related
53:15to the postpartum state is super
53:17important and I think that you really.
53:20Birth and so glad you brought that up.
53:22I will tell you what we
53:24is nice about our studies.
53:25We let the women keep their
53:27C pap machines if they're
53:28randomized to sleep apnea.
53:30So all of our patients you have
53:31sleep apnea in our randomized
53:33control trial get to continue to keep
53:35their machine and their equipment,
53:36and obviously their urge to follow
53:38up with a primary care doctor
53:39or sleep specialist regarding
53:41ongoing need and treatment.
53:45We have a lot of questions in the
53:47chat box and I'm glad you left some
53:50time for us here. Doctor tackle,
53:52but I'll try to get through them.
53:54Doctor motioning is asking
53:55if there's any relationship
53:57between weight gain and water,
53:58water weight and sleep disordered breathing.
54:00That's that's part of those
54:02factors. So great question.
54:03And actually there I want to
54:06refer you guys to a paper that
54:07was came out of Newmont to be.
54:10They didn't have time to review,
54:11which looked at prediction
54:13and sleep apnea in pregnancy.
54:14The greatest.
54:16Predictors words.
54:18BMI and frequent snoring.
54:20They did specifically look
54:21at waking and pregnancy.
54:23They found that weight gain in
54:25pregnancy was associated with
54:27sleep apnea in the mid trimester
54:29that that visit 3 assessment.
54:31But when they looked at strong
54:34predictor it didn't really improve
54:36the prediction model that much.
54:38So there is associations with excessive
54:40weight gain and an increased rate.
54:43But fundamentally,
54:44what really kind of differentiated
54:46risk was baseline BMI.
54:47I'm going into pregnancy.
54:50And that paper is the first
54:52author of that paper.
54:53Is Juliette Lewis and it's
54:55a really great paper.
54:56And it actually is links to
54:58an online risk Calculator for
55:00sleep apnea and presidency.
55:04We have a question about how many
55:06hours of sleep would you recommend
55:07for pregnant women at this point.
55:10I mean, I think that what we tell
55:12pregnant women at least clinically,
55:13you know what I do is that we should follow
55:16general sleep health recommendations that
55:17are out like the National Sleep Foundation.
55:20Kind of recommending you know 7 to 9 hours
55:22of sleep in general for healthy adult sleep.
55:25But we also do, you know, talk about that.
55:27Each individual has their own sleep need
55:29and there's certain some variations.
55:31Some people need a little less and
55:33some people need a little more,
55:34but generally I try to tell people to
55:37aim for kind of seven to nine hours,
55:39which is, I think,
55:40the general recommendation for adults.
55:45I think David has.
55:46It is very engaging.
55:47You're talking as numerous questions here,
55:49but I'm going to pick one.
55:51David, I'm sorry, maybe you can contact
55:53a perbacco faculty address these others,
55:55but you wanted to know,
55:56but I guess the trajectory of the
55:58sleep apnea is the difference between
56:00those who develop mild sleep apnea
56:02during pregnancy versus those who had
56:04it prior to pregnancy.
56:05So what's interesting,
56:06if I kind of look at this slide here,
56:09we looked at like early pregnancy
56:11and then mid pregnancy and obviously
56:13in the mid pregnancy sleep apnea.
56:15These are a lot of women who
56:17had sleep apnea and continued to
56:19have it as pregnancy progress,
56:21but it also contained nuance set.
56:24Sleep apnea out participants in,
56:26you know, in our sample we
56:28weren't able to kind of really
56:30differentiate a lot the risk of
56:32new onset versus pre existing,
56:34but I will tell you kind of clinically.
56:36In another work I do think what
56:38is probably the most relevant
56:40pathophysiological from a pathophysiology
56:42perspective is that preeclampsia
56:44that is either preexists pregnancy
56:45and you go into pregnancy with it
56:48or you develop it very early on.
56:50Between that 16 and 20 weeks with
56:53some weight gain and some of the.
56:55Physiologic changes of pregnancy
56:57so that early pregnancy period and
56:59that's why we chose in the MSM.
57:01You trial to kind of really focus
57:03on screening between 16 and 20
57:06weeks because of that,
57:07that probably the the longer exposure
57:09to the sleep apnea and the exposure
57:11earlier in pregnancy is probably
57:13leading to an increased risk.
57:15But I do think it's like looking at
57:17the the shift stational diabetes data
57:19preeclampsia data that you can't argue
57:22that even developing it later is a relevant.
57:24So what I?
57:25Typically tell people who ask
57:27about like clinically, what you do.
57:29Obviously,
57:29outside of a trial,
57:30like right now what we're trying
57:32to do is get all these women
57:34you know into these trials,
57:35but you know, outside of a trial,
57:37I tell individuals if someone is coming to
57:39you pregnant with a lot of sleep complaints.
57:42I can't stay up during the day
57:44I'm falling asleep at the wheel.
57:45I can't take care of my kids.
57:47'cause I'm,
57:48you know, sleeping.
57:49My husband tells me it's more out of time.
57:51I like CEREC because of all of this.
57:53Absolutely no matter when in
57:55pregnancy they present to you.
57:57It's important to refer them
57:58for evaluation and treatment.
58:00Do I think referring someone
58:01at 34 weeks is going to alter
58:03the course of their pregnancy?
58:05Well, I don't know for sure,
58:07and there's no definitive data,
58:09but I'm not as excited as excited
58:11about that as like in terms of
58:13more screening and treatment early,
58:15but certainly from the point of
58:17view of helping pregnant women
58:19function and have good.
58:21Sleep quality and daytime functioning
58:22if they're coming for that complete.
58:24It doesn't matter what.
58:25Just stational age period.
58:29Great and just a couple.
58:30Maybe we can get in a couple
58:33of one or two questions
58:34other than BMI and snoring.
58:37Are there any other screen
58:39screening tools for pregnancy for
58:41pregnant women and see this sort
58:43of breathing so you know there's
58:45a lot of data about using kind
58:47of the Berlin questionnaire or
58:49the Stop Bang Questionnaire?
58:51You know, those are fine,
58:53but fundamentally they don't function
58:55much better than BMI and snoring,
58:57and that's what, basically.
58:59That paper, Juliette Lewis is
59:01paper kind of came to kind of.
59:05A conclusion that those were the two best.
59:09Tools what has been shown over and
59:11over and over again at the every word
59:14is not a good tool for pregnant women.
59:17They are sleepy for way too many reasons,
59:19and the pregnancy in and of itself,
59:22and nausea and vomiting and all the other
59:24problems that are associated with that
59:26disrupt sleep or early daytime functioning.
59:28Increase those complaints.
59:29And by screening with the every work you're
59:32not really defining a good code word to test,
59:35so I will tell you, I don't think that
59:38it's necessarily wrong to use the.
59:40Or later they stopped stopping
59:42or the other kind of sleep apnea.
59:45Tools that have focused on BMI
59:47and snoring in their tool.
59:49But it turns out daytime sleepiness in
59:52and of itself is not a good predictor.
59:56We just have a comment from Doctor Rodriguez.
59:58I don't want to leave him out.
59:59He was just saying that.
01:00:01It would be interesting to follow the
01:00:03children of these pregnant women who had,
01:00:05I guess, untreated sleep apnea and
01:00:07see if there's a correlation of
01:00:09the city, yeah?
01:00:11That's not very interesting.
01:00:13And we actually do have,
01:00:15and I don't quite have the data already,
01:00:18but to stay to me actually followed all
01:00:20these new mom to be women who had untreated.
01:00:24You know, sleep is mild to moderate
01:00:26sleep apnea and pregnancy and follow
01:00:28them up two to seven years postpartum
01:00:30for cardiovascular metabolic disease
01:00:32and we will be kind of eventually,
01:00:34hopefully soon publishing data
01:00:36regarding sleep apnea in pregnancy,
01:00:38how it potentially persists or
01:00:39resolved in the postpartum period.
01:00:41Cruise is a subgroup of them
01:00:43agreed to be retested postpartum.
01:00:45At the two to seven year Mark
01:00:47and then how it how it relates to
01:00:50cardiovascular metabolic measures.
01:00:51Two to seven years after delivery.
01:00:56So I know a few people jumped off this.
01:00:58There's a follow up from.
01:01:01Follow up conference.
01:01:02Grand rounds after this book.
01:01:03For those who are still on,
01:01:05I don't know.
01:01:05Maybe you want to ask your
01:01:07question since you had a
01:01:08couple of questions there.
01:01:11I think you're muted.
01:01:14Yes, I am muted. Sorry it's
01:01:16just a really interesting topic to me
01:01:18and I was wondering so is there data on
01:01:21whether later pregnancies are more or
01:01:23less effective than earlier pregnancies?
01:01:25Like just a number of parity or gravity?
01:01:29Affect the results. So really
01:01:31interesting. And in fact in so this than
01:01:33you Mom data is all on the liparus within.
01:01:36So first time moms and it was designed
01:01:38that way for a reason because you kind of
01:01:41remove a lot of confounding factors from
01:01:43prior pregnancies and risks related to that.
01:01:46But in our trial we're not
01:01:48limiting it to first time moms.
01:01:50We're doing first time moms and Paris
01:01:52women and we actually do find that Paris
01:01:54women have higher rates of sleep apnea.
01:01:57In our trial day screen at a higher rate.
01:02:00Probably also related to the
01:02:01fact that they're older,
01:02:02'cause you know just we have more kids.
01:02:05You get older,
01:02:06so they're they're older and there they
01:02:08tend to have higher BMI 'cause you know,
01:02:11unfortunately,
01:02:11that's what happens as we get older too,
01:02:13so they are at increased rates.
01:02:15So actually, I don't think this is
01:02:17just an issue with first time moms.
01:02:20I think it's important also to screen other
01:02:22at risk women in subsequent pregnancies.
01:02:25That's really interesting Doctor Falco.
01:02:27So why do you use home sleep apnea
01:02:30testing that is dependent on flow
01:02:32'cause we wish we have both systems.
01:02:34We use home sleep apnea testing
01:02:36that is dependent and then we
01:02:38use pulls arterial tonometry,
01:02:40especially in the younger
01:02:41populations that the path is
01:02:43seems to be a lot more sensitive.
01:02:45You could already eyes that are
01:02:47much higher than the hi and so I
01:02:50would think that this particular
01:02:52population would be very amenable to
01:02:54that type of testing like we might
01:02:56have some very interesting findings.
01:02:58I I think that's super interesting,
01:03:00and in fact when we designed the trial,
01:03:03we brought up two things.
01:03:05We brought up what device to use an watch.
01:03:08Pat came up, you know which uses
01:03:11peripheral tear tanama tree and part
01:03:13of it was cost those systems in
01:03:15terms of research costs were much
01:03:17more prohibitive for the the study.
01:03:20The other concern was, you know,
01:03:22in gathering as much data as we
01:03:24could in terms of what the sleep
01:03:27apnea look like physiologically.
01:03:28From both the flow and a
01:03:30pulse oximetry perspective,
01:03:31it went back and forth.
01:03:33We also went back and forth in terms of
01:03:36should we use ody greater than or equal
01:03:38to five as inclusion in the trial or not,
01:03:41and whether or not that would be enough
01:03:44because some women you know meet ody
01:03:46criteria but don't quite have the like flow.
01:03:49The flow events aren't quite enough
01:03:51to count in those and then so they
01:03:54screen out based on hi and you know,
01:03:56I don't think there's a right
01:03:58or wrong answer,
01:03:59and obviously for a trial you just
01:04:01have to make some decisions and.
01:04:03Kind of go with them,
01:04:05but I do think it's super interesting
01:04:08to think about kind of non flow
01:04:11related ways to measure sleep apnea,
01:04:13including simpler cost, effective ways.
01:04:15Potentially even just with
01:04:16nocturnal pulse oximetry.
01:04:18And I know that there is some interest
01:04:20in we're using the Sleep Rating Center.
01:04:23Doctor Susan Redline is our is our
01:04:26coordinator of our H Set meetings
01:04:28and she's constantly pushing us
01:04:30to think about these things.
01:04:32And you know, who knows?
01:04:34Maybe download.
01:04:35Trying to get some modifications to our
01:04:37inclusion criteria to re evaluate that,
01:04:39but I totally agree with you
01:04:41and I think that it's in.
01:04:43It's important to think about those
01:04:45and also that pregnant women don't love
01:04:47going home with the you know nasal.
01:04:49Yeah,
01:04:50monitor it it they do well when
01:04:51they are properly trained,
01:04:53but it's a huge area where it falls
01:04:55offen in the trial then they if they
01:04:58don't get a good signal from the
01:05:00respiratory belts they have to like we do it.
01:05:03And so I agree be super interesting
01:05:06to explore that and in.
01:05:08Large group of pregnant women.
01:05:11Great, thank you so much for
01:05:12this very excellent talk.
01:05:14I like I said few people had to peel
01:05:16off because of the the grand rounds.
01:05:18But thank you, we really appreciate it.
01:05:20Really informative and we're happy as
01:05:22a as a institution to be part of your
01:05:24clinical trial with were eagerly waiting.
01:05:26The results of that alright?
01:05:28Well, thank you so much.
01:05:29I really appreciate the opportunity.