" Sustained Effects of Cognitive Behavioral Therapy for Insomnia in Chronic Heart Failure " Nancy Redeker (12/08/2021)

December 27, 2021

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00:00Again, wonderful.
00:05Thanks for doing this, Nancy.
00:07Thank you for the invite.
00:09Yeah, it should be fun.
00:15There we go. People are joining. Excellent.
00:27Hello hello.
00:34We'll get started in just
00:35a couple of minutes.
00:51All right, I think we're reaching
00:53a critical mass of 30 participants.
00:55Excellent. Hello Mayor,
00:57thanks for the note. Hi everyone,
01:00my name is Andres in truck and I want
01:04to welcome you back to our Joint Sleep
01:07Conference and seminar between Yale BIDMC,
01:10Brigham Women's BMC and Tufts Sleep Center.
01:13So it really sounds like a northeastern
01:16conglomerate and a few announcements.
01:18Before we start and I introduce
01:20today's speaker, doctor Nancy Redeker.
01:22First, Please ensure that you are muted
01:25during the talk and to receive CME credit.
01:28Please see the chat room for
01:30instructions which will be posted there.
01:31A few minutes after we start,
01:33if you're not already registered
01:35with the CME at Yale,
01:36you will need to do so first to get
01:38credit and recording of this session will
01:40be available online after two weeks at
01:42the link that we provided in the chat.
01:45And if you do have questions during the talk,
01:47please make use of the chat rooms
01:49throughout the hour and at the end we
01:52hopefully will have a productive session,
01:54and so without further ado,
01:57I wanted to introduce with great pleasure
02:00to a speaker doctor Nancy Reticker.
02:03And for a joint conference today.
02:04And so,
02:05doctor Reticker has completed her nursing
02:08training at Seton Hall and then earned
02:11a PhD of Nursing Research NYU in 1990.
02:13And then she went on to become a professor
02:16of nursing at Wreckers University
02:18before being recruited to Yale School
02:20of Medicine as the director of Yale's
02:22nursing PhD program and director of
02:25the by Behavioral Laboratory here,
02:27which has catalyzed really
02:28catalyzed the research at Yale.
02:31So Nancy has been conducting research at the,
02:34you know, NIH,
02:35funded and otherwise funded
02:36research in chronic illness,
02:37sleep, and health outcomes.
02:38So the past 30 years and reviewing
02:40her CV was really fun and I wanted to
02:42share a first research paper with you,
02:44which was published in 1989,
02:47titled Health Beliefs,
02:48Health Locus of Control,
02:49and the frequency of practice of
02:52breast self examination in women.
02:54And in the 150 papers and more.
02:57Since that time,
02:58she's focused on a wide range of topics,
03:00including sleep,
03:01health and underserved communities,
03:02children and adults with severe comorbid
03:04conditions such as heart failure and in
03:07addition to being a prolific researcher,
03:10Nancy has been a committed mentor,
03:12helping junior investigators from many
03:15different fields including nursing,
03:16physiotherapy,
03:17psychology physicians,
03:18myself included to careers in research.
03:21So thank you,
03:21Nancy for myself and Oreo mentees.
03:25And Nancy is more recent.
03:26Focus has been improving quality
03:28of life in individuals with sleep
03:30disorders and heart failure which
03:31we all know is a highly prevalent
03:33and highly morbid condition.
03:34And So what Doctor Recker has done is
03:37focused beyond the sleep disturbance as
03:39classically attributed to sleep apnea.
03:42In this vulnerable population.
03:42And so I'm excited to hear her
03:44talk on the topic today,
03:45and so let's please give a warm welcome,
03:48digitally or otherwise,
03:50to Doctor Rediker and go ahead and
03:52Nancy thank you.
03:56Can you see are we good?
03:57We got the slides up OK, yeah.
04:00So anyway, thank you everyone.
04:03I have nothing to disclose here and the
04:05information is here about your CME credits.
04:08So thank you for that nice introduction.
04:10I think it's funny that you
04:12mentioned my first paper,
04:13so I had to do research and I had little
04:15children in the daycare setting and I
04:18wasn't that interested in breast self exam,
04:20but I knew I could get all these preschool
04:23mothers to fill out my questionnaire so
04:25it's interesting how our work evolves.
04:27Anyway, after that I became a corner
04:29carry unit nurse and that's how I
04:31got interested in heart disease.
04:32So the title of my talk today is cognitive
04:35behavioral therapy has sustained effects
04:37among people with stable heart failure.
04:40So as most of you probably know,
04:42heart failure presents a large
04:44burden in the population.
04:45There's about 26 million people throughout
04:47the world who have heart failure,
04:49and of course they have
04:51lots of comorbid problems,
04:52but they also have high symptom burden.
04:55They have a lot of fatigue.
04:56They have dyspnea.
04:57I think I learned that in my
04:59second day of nursing school,
05:00but they also have a lot of
05:02depression and sleep disturbance.
05:04And we'll talk a little obviously talk a
05:06little bit more about that in a minute,
05:08as well as poor function and quality of life,
05:11cognitive dysfunction,
05:12and it also costs the healthcare system
05:14quite a lot of money to be able to
05:17treat them as well as what we've often
05:19focused on in terms of specific sleep
05:22disorders such as sleep disordered breathing.
05:24When we think about sleep disorders in heart,
05:26failure,
05:26of course,
05:27and I'm sure many of you in the room
05:30are from a pulmonary perspective,
05:31are aware and have focused on sleep disorder.
05:34Everything and we know 50% or more have
05:37either central or obstructive sleep apnea,
05:40or both.
05:41There's also some prevalence,
05:43increased prevalence of
05:44restless leg syndrome,
05:45but there's also a lot of self reported
05:48sleep complaints which we could call
05:50insomnia and I'll get to him in a minute.
05:52How I defined that,
05:53but there's a lot of questions
05:55in the literature you know in in
05:57our clinical practice as well.
05:58If so,
05:58is there a sleep disturbance
06:00only due to sleep apnea?
06:01Is it due to nocturnal symptoms?
06:03Is it also?
06:05Comorbid with depression and anxiety.
06:08We also know that heart failure patients
06:10are on many different medications,
06:11of which many are most,
06:13could contribute to poor sleep.
06:15But finally,
06:16is it also a learned behavior associated
06:19with perpetuating factors as well as
06:21hyper arousal from a physiologic as
06:24well as a psychological perspective?
06:26And are these things that might
06:28be amenable to treatment?
06:30So when we drill down a little bit more
06:34into specific symptoms and this comes.
06:36From some of our earlier work,
06:37as many as 70% of heart failure
06:39patients both heart failure with
06:41preserved ejection fraction heart
06:43failure with reduced ejection
06:45fraction have symptoms such as difficulty
06:48initiating sleep, staying asleep,
06:50waking too early, not enough sleep,
06:52they nap a lot during the day.
06:54We have nocturia. In fact,
06:55people have said to me, well of course,
06:57heart failure patients get up a lot at night.
06:59They have nocturia difficulty sleeping flat,
07:02but there's also a huge amount
07:04of hypnotic use prescribed and.
07:06Not prescribed in this population.
07:09So some of these might be specific
07:10to one sleep disorder or another,
07:12and in a minute I'll explain
07:14how we got to insomnia.
07:16So when we looked at these in a
07:18sample which which was collected.
07:20Oh, I can't believe it's almost 20 years
07:23ago we started this work when I was in
07:26New Jersey and Robert Wood Johnson.
07:28Hospital I'm looking at sleep symptoms
07:30and people with heart failure.
07:32We recruited 59 patients with heart
07:34failure and healthy controls which
07:36were pretty well matched on age,
07:38gender and comorbidity, and we said,
07:40well, do heart failure patients really
07:42have poor sleep than other people?
07:44And we weren't looking at some
07:45sort of breathing here.
07:46This is a pretty low budget study.
07:48We were looking at self report
07:50and actigraphy, but so on.
07:52Almost every measure, falling asleep,
07:54staying asleep, waking too early,
07:56not enough sleep, more naps.
07:59Over 50% of heart failure patients took
08:02naps during the day pauses during this sleep.
08:05Interestingly enough, leg twitching.
08:07They had nocturnal dyspnea,
08:09but notably the control group had
08:11just had as much as more snoring,
08:14but also had as much more nocturia.
08:16So these are sort of common things
08:18that we think are,
08:19are, you know,
08:20related to their their staying awake
08:22with the heart failure patients?
08:23At least in this.
08:25And this was self report data.
08:27We're not higher on those other things.
08:30So we also collected actigraphy.
08:32This is data from a little bit
08:34more recent study,
08:34but the data from the early study
08:36looked the same and most of you are
08:38probably familiar with actigraphy.
08:40Each one of these lines is a
08:4212 hour day from noon to noon,
08:44and the little black marks here
08:46are their activity.
08:47The red marks is where the
08:49device says they're awake.
08:50The line along the bottom and
08:52then here in the blue is where it
08:54indicates this is their sleep time.
08:56What you notice here is there's a
08:58lot of irregularity and bedtime.
09:00There's also a lot of little tiny,
09:02whether their arousals or just movements
09:04we don't know because this is actigraphy,
09:07but there's a lot of disturbed sleep and
09:09just to be said in a very unscientific way,
09:12and so this is really been a focus
09:14of our work as to to consider
09:16addressing some of that.
09:18So when we looked at the actigraphy
09:19again in this very small sample,
09:21what we saw, this is the heart failure.
09:23Patients again compared to
09:25the comparison group,
09:26they had pretty close to the
09:28same sleep duration.
09:30They had more wake after sleep onset.
09:32This is in the bar graph at the right,
09:33with the statistics on the left
09:36and they awaked awake and much
09:38more frequently during the night.
09:40But interestingly enough they
09:42also had longer time in bed,
09:44which probably explains
09:45their poor sleep efficiency,
09:47notably the heart failure patients also had.
09:52I'm not sure what happened to
09:53the alignment in this slide,
09:54but had longer sleep latency.
09:56Almost half of these patients
09:58had prolonged sleep latency and
09:59this was the median level then,
10:02then the the comparison group.
10:05So this LED us to think so.
10:07So this lead us to a larger study
10:09which we got funded from an order
10:11one and the question was how is sleep
10:14disturbance as you see in wait in the middle?
10:16How does sleep disturbance and we didn't
10:19mean this specifically as a specific sleep.
10:22Diagnosis but sleep
10:24disturbance more generically,
10:25how did that explain the outcome here?
10:28Was functional performance and how did
10:31it explain daytime symptoms and in turn,
10:33did these symptoms mediate the
10:35relationship between complaints of poor
10:38sleep and the the functional outcome?
10:40And you look we did.
10:41We did do we did home PSG on all of
10:43these patients full PSG and we did
10:45measure sleep disordered breathing.
10:47We measured PLM's.
10:48We measured and et cetera,
10:51and so we were able to recruit
10:54about 175 patients.
10:55It's 175 and with a mean age of 60.
11:01Ejection fraction,
11:01interestingly enough,
11:02when we started this study,
11:04we were only looking at patients with
11:06reduced ejection fraction and then our
11:08cardiology colleagues got really smart,
11:10much smarter about sleep,
11:12disordered breathing.
11:12And so we we originally set out to take
11:15people that were completely naive.
11:17Any sleep treatment and take
11:19a broad cross section,
11:20but that got harder and harder to do,
11:22so we had both patients with
11:24reduced and preserved ejection
11:25fraction in this study with the
11:27mean New York art class of 2.5,
11:29the majority of the patients were obese.
11:31So just to give you a flavor
11:33this and I am going to get to
11:35the intervention in a minute,
11:37but I wanted to explain how we
11:39got to the intervention when we
11:41compared the patients on the apnea
11:44hypopnea index across quartiles.
11:46What you see here in on based
11:48on their symptoms and function
11:49'cause we were interested.
11:51This was the primary outcomes was
11:53function and symptoms as you see here
11:55on the left and when we compare it
11:58across the hi quartile with the first
12:00column being the overall number.
12:02And the the 3rd, 3rd, 2nd,
12:043rd,
12:044th and 5th column is being the HI
12:06court that there was no difference in
12:09self reported sleep with the piskey.
12:11No difference in depression,
12:13no difference in global fatigue,
12:16no difference in the Epworth and no
12:19difference in the six minute walk
12:21across apnea. Hypotony index cord piles.
12:23The only difference was a little bit
12:26less physical activity on the actigraph,
12:29which you see only in the 4th quartile.
12:32These were people with an HI
12:34and you see our
12:35court tiles here pretty much corresponded
12:37to clinical levels of the HI and so it
12:41was only at that level and so well.
12:43So what is it about sleep if it's not the hi,
12:46that's sort of contributed.
12:48So what we found out was that overall,
12:51about half of the patients reported
12:53difficulty initiating sleep,
12:55maintaining sleep or waking too early.
12:57Half of them had difficulty maintaining.
12:59OK, that's pretty nonspecific.
13:0242% had difficulty falling asleep.
13:04And 24% woke up too early in the morning.
13:07Insomnia was a little bit more
13:08prevalent in the women than the men,
13:10although this wasn't significantly
13:12significantly different and the
13:14insomnia is not associated with age.
13:17The HI or left ventricular LV.
13:23So this is just some,
13:25some of the data comparing people with
13:28and without insomnia with insomnia in
13:30blue without insomnia is in the red.
13:32Comparing those folks on levels
13:35of sleepiness, depression,
13:37fatigue, and physical function.
13:39The six minute walk to fit on this slide,
13:41you have to multiply this by 100.
13:44So there was about 100 foot
13:46difference in six minute walk distance
13:49between the patients with insomnia
13:51and the people without insomnia.
13:54And so you know.
13:55So it was sort of.
13:57One would expect that we might see some
14:00effectivity going on here that people
14:02with more insomnia might report more
14:04daytime symptoms and poorer function.
14:06But this is an objective measure
14:08commonly used in cardio pulmonary care.
14:10And there was 100 foot and statistically
14:13significant clinically significant as
14:15well difference in the six minute walk.
14:17So we published both of these
14:19papers in the journal SLEEP.
14:20And again, I can't believe it's 2010 already.
14:24And and and so this was sort
14:26of the take home message.
14:28Insomnia seems to be important
14:30to function in these patients,
14:32so the next question was, well,
14:33what are we going to do about this, right?
14:35So here's our model.
14:37Well, we could give kpap,
14:38but we were interested in daytime
14:41function and fatigue and mood and it
14:44we didn't see a difference in the
14:46hi on those variables we could give
14:48Hypnotics and I'll explain a little bit
14:50more why we didn't do that in a minute.
14:52Of course,
14:53everybody could use better heart
14:55failure disease management.
14:56We could do more physical activity
14:58to improve function.
14:59We obviously could improve stress.
15:02A lot of these patients were depressed.
15:03We could do any depressants,
15:05but we just said let's let's look
15:07at CBT eye and see if we can get
15:10a better outcome on the function
15:12and symptoms with this treatment.
15:15So.
15:17Just as a review,
15:18I'm sure you're all familiar with this.
15:20The this is the ICD 3 definition of insomnia,
15:24which pretty much is corresponds to what
15:28we we were observing in our patients.
15:31So we said, OK,
15:32I'm you know I'm I'm sort of
15:34a very quantitative person,
15:35but I thought it was very important.
15:37If we were going to develop an intervention
15:39to go back and see what the patients say.
15:42So we after we did this study and this we
15:44did after I came to Yale with a colleague,
15:46Doctor Laura Andrew Scheer,
15:47in our critical care program,
15:49who is an expert in qualitative research.
15:53We went back to the heart failure
15:54patients and said if we were
15:56going to build an intervention,
15:57what would you be interested in?
15:58How important is your sleep and?
16:01If we were to build a
16:03behavioral intervention,
16:03would you come?
16:05And So what they told us is insomnia was
16:09very important to them in that quote,
16:11and that this is the title of the paper.
16:13I need a bucket of nails.
16:14If I thought it would help me sleep.
16:17I go to bed knowing that,
16:18so we asked them well,
16:19what happens at night.
16:20I go to bed knowing that I'm not
16:22going to sleep and it bothers me.
16:23OK, so this kind of catastrophe
16:25station is really part of insomnia.
16:27Dear God, please let me sleep tonight.
16:30They talked about all some of the
16:32typical cognitions we think about
16:34in behavioral aspects of insomnia.
16:36Notably, very few people told us that
16:38it was their heart failure symptoms
16:39that we were keeping them awake.
16:41Very few people told us it
16:43was nocturia or disneya.
16:45Most of them had these sort of obsessive.
16:47Thoughts most of the patients were
16:49in some kind of in in hypnotic,
16:52either prescribed or not prescribed,
16:54but they were all whether they
16:56were on a addicting Med or not.
16:58We're all afraid of becoming addicted,
17:01addicted.
17:02They had some very.
17:06Very strange behaviors.
17:07The one lady that we were two different
17:10drugs that that she could have been on.
17:13One might have been a 5 milligram dose.
17:15One would have been a 10
17:16milligram dose and she'd say,
17:18well I want to take the 5 milligram because
17:20it's less because it's less powerful.
17:22I'm not going to get addicted somebody else
17:24said I'll just nibble off a little bit.
17:26It's not like taking the whole thing
17:28but mostly what they said is doctors
17:30don't ask and patients don't tell
17:32we go to in most of them obviously
17:34we're not going to a sleep doctor.
17:36That we go.
17:37We go to the point to the my
17:39cardiologist or my primary care doctor
17:42or my advanced practice provider and
17:44they don't ask me about my sleep.
17:47And I know they don't have time.
17:48They want to take my blood pressure.
17:49They want to give me a pill and
17:51so I leave without telling them.
17:53So for us.
17:54And then we did ask them more about.
17:56Well, if we built an insomnia intervention,
17:58you know a behavioral intervention.
18:00Would you be interested in it
18:01given all the other things you
18:02need to do to manage their health?
18:04And they unanimously said yes.
18:07So we proceeded to conduct.
18:08This was another study funded
18:10within or 21 from the National
18:12Institute of Nursing Research.
18:14A feasibility and efficacy study
18:16of CBT for insomnia and this
18:18was published in the Journal of
18:21Clinical Sleep Medicine in 2015.
18:23So basically what this was and we
18:25wanted to very carefully control
18:27for time and attention,
18:29so we randomize people with heart failure,
18:31patients with an insomnia severity
18:33index of greater than seven into
18:36groups 7 is considered the cut
18:38off for no versus some insomnia.
18:41The cutoff for on the ISI.
18:42For those of you know it is a
18:44little higher for clinical insomnia,
18:45but we didn't know what levels
18:47of insomnia would merit treatment
18:49in these particular patients.
18:50So we took anybody that had at least
18:53mild insomnia. And we randomize.
18:55This is a group interventions.
18:56So we randomized them in groups to four
18:59BI weekly sessions of pretty standard CBT.
19:01I sleep hygiene and cognitive therapy,
19:04sleep restriction,
19:05stimulus control.
19:06We also added progressive muscle
19:08relaxation and the reason we did
19:10that was because there's such a high
19:13arousal level in these patients,
19:14the control group was heart failure,
19:17self management,
19:17which is pretty much consistently
19:19what heart failure patients should
19:21know when to call the doctor
19:23with how to take your medication.
19:25What symptoms weren't follow up low fat?
19:29Low sodium, diet, exercise, etc.
19:30We did include some fleet very simple
19:33basic sleep hygiene in there because
19:35we felt that it was a question
19:37of equipoise we couldn't recruit
19:39people into an insomnia trial and
19:41not do anything at all about,
19:44you know,
19:44to keep A to keep them in the trial,
19:46but be nothing at all,
19:47and so the literature suggests
19:49that sleep hygiene alone is
19:51not an active component of CBT.
19:53I so that was in here.
19:56And and arguably,
19:58improving your heart failure might
20:00actually also with with self management
20:03might also improve your sleep.
20:05We had this pretty much the same outcomes
20:07that we had in the earlier study,
20:09so I'm going to skip over this,
20:12but we had 59.
20:14We had 29 people in the CBT I which we
20:17called healthy sleep and 19 people in
20:19the healthy hearts which was the control.
20:21It was a pretty diverse group.
20:23The only difference was,
20:25interestingly enough,
20:26the CBT I group had a little bit.
20:29A little bit more comorbidity,
20:31which would have argued
20:32against the treatment effect.
20:33However,
20:34we did show that we and we were
20:37primarily focused here on effect size,
20:39not statistical significance,
20:40because this was a preliminary study,
20:43but we did see a very large improvement
20:46in the CBT group versus the attention
20:49control on insomnia severity.
20:52You see the in the far right hand
20:54corner side. Here is the effect size.
20:57We also saw a lot.
20:59Improvement in the PISKI as well as,
21:02interestingly enough,
21:03a large effect on fatigue.
21:06Now that you know a lot of people in
21:08cardiology aren't that focused on sleep,
21:10but most of us know that,
21:11think that fatigue is pretty
21:13important outcome.
21:14And so, so this was a pretty large effect.
21:16We also saw some improvement
21:18in Actigraph measured sleep,
21:19latency, duration and efficiency.
21:22Although everybody had poor sleep
21:25efficiency pretty much throughout,
21:26and this has been in all of my
21:28studies in sleep efficiency of.
21:29High 70 to 80%.
21:33So this is the manova where
21:35we combine the outcomes.
21:36Not only were these large effects,
21:39but they were statistically
21:41significant when we considered
21:43insomnia and fatigue together,
21:45so the overall effect on both insomnia
21:48and fatigue was I was at a .02 level
21:50and it was considered a large effect.
21:53So this was our preliminary work
21:55when I'm going to move to is to
21:58talk about this is a pre load
22:00to how did we get to the trial
22:02that that we're just reporting?
22:05Today So what I'm reporting today,
22:08and I'm excited to announce it's
22:11just been published in Sleep,
22:12is the results of our five year clinical
22:15trial that built on all of that other work.
22:18Again, I can't believe how time flies.
22:22And so we'll, that's that's the next.
22:24I'll segue to that.
22:25So this was a model that builds
22:28directly on that earlier work,
22:30and on the right hand side you
22:33see the intervention is CBT.
22:34And as we know,
22:35CPT is designed to work on our
22:38thoughts and our behaviors, right?
22:41And so the focus was CBT I.
22:43And how can we use that to improve
22:45that and in turn improve insomnia?
22:48But we were also interested
22:50in these other outcomes.
22:51Again, very important in heart failure.
22:55The primary outcome in this study,
22:57again based on our preliminary work,
22:59was fatigue.
23:01In terms of the symptom outcomes,
23:04and then the other primary outcome was six
23:06minute walk and self report using the SF 36,
23:10we also measured psycho motor vigilance.
23:12We haven't, we haven't
23:14finished analyzing that yet.
23:16Secondary aim was also to look at
23:18health care resource utilization and
23:20my colleague Doctor Chris holiday get.
23:22The Penn State is a economist with
23:25expertise in this area and he is working
23:27on those data as we speak and then uh.
23:30Another sort of tertiary aim was to
23:33consider event free survival given
23:36some of the increasing evidence
23:38that insomnia predicts outcome.
23:41Because this is such a dirty business in
23:43terms of looking at the inputs into insomnia.
23:45Of course we have multiple other factors.
23:48We have sleep apnea.
23:50We have adherence to their self care.
23:53We need,
23:53we have comorbidity and other factors,
23:55and they were all considered.
23:59We did, by the way,
24:00so so the study design included.
24:03It was a randomized controlled trial with
24:06a modified intent to treat approach.
24:08What I mean by that is everyone that
24:11randomized and everyone but included
24:13to the extent we could in the analysis
24:16and what we realized at the end
24:18is that we lot we did not include.
24:21There were some people at baseline
24:22that had missing data,
24:23so that's why it's a modified intent
24:26to treat. We did screen people.
24:28We used the.
24:29Darius device to screen for sleep
24:32disordered breathing and to be
24:33in the trial you had to either be
24:36adherent on PAP or you had to have
24:38an age that I have less than 15.
24:41And as you can imagine that is
24:42was a huge challenge and I'll talk
24:44about that in a minute.
24:45So again,
24:46we we're running this
24:48intervention as a group format.
24:50We randomizing groups after the baseline
24:53the participants were blinded until
24:56they showed up for the group the the CBT.
24:59Why was run by a psychiatric nurse
25:03practitioner who had trained in CBT?
25:06I and the control condition was the
25:09healthy Hearts group was run by a
25:12nurse practitioner with expertise
25:14in heart failure care.
25:16And one of our long term goals.
25:18Given that we know there's such
25:20a shortage of behavioral folks
25:22available to treat insomnia,
25:24one of our goals was to make this as
25:27simple and codified and procedural
25:29as we possibly could,
25:31so that long term we could get people
25:33that were not sleep specialists with
25:36short training, such as calling.
25:37SB is done in the UK to train
25:39nurses and other people to be able
25:41to deliver this with the idea of
25:43ultimately being able to disseminate
25:45it into the heart failure.
25:47Practice so we collected baseline data.
25:51Our measures were at one month post
25:54treatment and at 6-9 and 12 months.
25:57The primary outcomes I do not
25:58include that we have a large number
26:00of variables with the primary
26:01variables are listed here.
26:02The ISI sleep.
26:04Interestingly enough,
26:05in one of the revisions of this grant,
26:07the NINR decided that they
26:09wanted everybody to use the
26:12promise measures instead of the, you know,
26:15other sorts of measures because they
26:16wanted people to begin to standardize.
26:18These measures, but all my effect
26:20sizes were based on the other measures,
26:22so we have some double measures in here,
26:24but that that that'll be an
26:26interesting analysis as well.
26:28So we did measure sleepiness.
26:29We measured 6 minute walk in SF 36,
26:32so again, it's the same,
26:34exactly the same intervention
26:35that we had in our earlier work.
26:39So we we screened.
26:42We invited 14161 participants.
26:45We screened many more than that.
26:47We assessed 304 for eligibility.
26:50We screened out a large number
26:52of participants for sleep,
26:53disordered breathing and many, many, many.
26:55Said I.
26:56I don't want to be in your
26:58trial because I have insomnia.
27:00I have a poor sleep.
27:00I don't know if that it was insomnia.
27:02I have poor sleep,
27:03but I don't want to use my CPAP.
27:05So we ruled out a whole lot
27:07of people because of that.
27:09But anyway,
27:10we randomized in clusters 189
27:13participants and 100 were allocated
27:15to the CBT I and 89 to the
27:18attention and control we ended up.
27:21And this is where the we analyzed 91
27:24in the CPT I and 84 in the control.
27:28So this very busy slide shows
27:31the the comparison.
27:33The group was comparable on most measures.
27:35The average age was around 63,
27:37sample was 57 or 58% male.
27:41It was about 1516 for 16 percent,
27:4517% African American overall and they
27:47look very similar to our early work.
27:50The average BMI was in the the obese range.
27:55New York art class.
27:56They were not as as given that
27:58we were recruiting out of,
27:59yeah,
27:59which is an advanced heart failure program.
28:01A lot of them had fairly low levels
28:04of New York heart class at one and
28:07two heart failure class about a
28:10third of the patients had low EFC and
28:14there was significant comorbidity.
28:16We did not say that you had to be off
28:18your hypnotic medications to be in the trial,
28:20but we did offer tapering
28:23in the intervention.
28:25So All in all,
28:26half of this sample had mild sleep,
28:29mild insomnia and and a little more than
28:32half had clinical levels and insomnia.
28:35So what did we learn?
28:36So this is the the 1st post
28:39treatment which it which was
28:40within two weeks of the follow up.
28:42So it was about three months after baseline.
28:45This is using.
28:48GLMM analysis and what you
28:50see here is that at baseline,
28:53most people had clinical level of insomnia,
28:56which is about 15 in the healthy sleep
28:59they dropped by by more than six points.
29:02They did also improve.
29:03Interestingly enough,
29:04in healthy hearts,
29:05but not nearly as much,
29:06so 6 to 7 is considered a
29:09clinically significant improvement
29:10in the insomnia severity Index,
29:12so we did pretty well at the first follow up.
29:15They also improved on sleep quality based on.
29:17Both of those self report measures
29:20they improve somewhat on
29:21their sleep efficiency, but only by
29:25about 5% and their sleep duration.
29:27Interestingly enough, improved a
29:29little bit in the Healthy Sleep group.
29:31What's interesting about that is that
29:34sleep restriction was a part of the CBT I.
29:38We also showed us didn't hide,
29:40realized I didn't highlight it here.
29:42We also showed some trends
29:45suggesting improvement,
29:46but it wasn't statistically insignificant.
29:49And fatigue and in excessive daytime
29:53sleepiness. Again, it wasn't in.
29:55And So what you see here is that
29:58this was the the far right corner
30:00is the group by time right?
30:02The first column we saw in within the
30:04healthy sleep we saw an improvement,
30:05but there wasn't a group by time
30:08difference at the at this early follow-up.
30:11So I'm sorry this is out of order.
30:14I no matter how many times you
30:15look at your slides,
30:16they're still out of order anyway,
30:18so we looked at the intervention
30:20effects at 12 months.
30:22So looking at change over time there was
30:25an early and sustained improvement in
30:27these variables and I'll show you this.
30:30The graph in a minute.
30:33But at 12 months we saw a nice,
30:36robust improvement and sustained improvement
30:39in insomnia severity such that the group,
30:42by time interaction was significant
30:45at 12 months.
30:47I didn't show you all the
30:48intervening data in here,
30:49just for time constraints,
30:52but and So what we we also controlled
30:54using the false discovery rate
30:56for the multiple comparisons,
30:57and you see that statistically
31:00significant insomnia severity,
31:01sleep quality, sleep.
31:03Latency as well as,
31:05interestingly enough,
31:06fatigue,
31:07excessive daytime sleepiness and
31:09six minute walk again in the
31:11heart healthy Sleep group.
31:13The first column here we saw
31:15over 100% improvement in the six
31:18minute walk with some improvement,
31:20but not nearly as much in the
31:23control condition.
31:24So this is a graphic display
31:27of on the top left,
31:29the mean and the insomnia severity
31:32on the left is the the actual and
31:36on the the right is the predicted
31:38based on the GLMM approach and
31:40what you see is that we saw the
31:43most dramatic improvement in the
31:45first follow up with the the
31:47continued level up to 12 months.
31:50So we taught these participants something
31:52and it looks like they're still using it.
31:55Over the 12 months.
31:57Earlier work was only a shorter term
31:59follow up so we were not able to see
32:02that this other slide shows the mean
32:04sleep quality and it looks very similar.
32:08So when we thought about these in a more
32:11dichotomized way, this slide shows the
32:14observed and estimated proportions of
32:17participants with clinical insomnia,
32:19daytime sleepiness using the typical.
32:23The X Epworth cut off and a six minute
32:26walk distance of greater than 1000 feet,
32:29which is often used as a clinical metric
32:32and in any case, So what you see here again,
32:36the healthy sleep in in the top left.
32:38This is clinical insomnia.
32:40You see the dark,
32:42the dark filled in black bar.
32:46Here is the healthy sleep.
32:48A healthy heart is in Gray.
32:50The solid line is the predicted and
32:54then the healthy hearts is the predicted.
32:56So the healthy sleep is predicted etc.
32:58And so you're seeing very
33:00much the same thing, right?
33:01So that 60% of the people at baseline in the
33:05in the healthy sleep had clinical insomnia,
33:08but it was only about 10 or 12%
33:11at the follow at this 12 months.
33:13Similarly for the PISKI and then
33:16excessive daytime sleepiness.
33:18Again, you see that dramatic
33:19decrease you see some decrease.
33:21History's in the control group,
33:22but not nearly as much,
33:25and it's not sustained.
33:27So,
33:28so that is in a nutshell is
33:31our is our results.
33:33We also showed though this is
33:34a sort of interesting graphic
33:36that our statistician prepared
33:37and what you see here is looking
33:40at sleep characters over time.
33:42Looking at them all together and
33:43we also I failed to mention again
33:45for time sake did not put in that.
33:47We have the dysfunctional beliefs and
33:50attitudes about sleep and the sleep
33:52Disturbance Questionnaire which is a measure.
33:54These are measures as you know
33:57about perceptions about sleep.
33:58And what you see here on the
34:00left is the healthy sleep group.
34:02On the right is the healthy heart group.
34:04And what this is showing the the
34:07outside of this is showing baseline
34:09and then this looking at the shrinkage
34:12essentially is how it is changed
34:14overtime and you see there's a lot
34:16more sleep disturbance in the healthy
34:18heart here on the right hand side.
34:20This is trying to let us look at all
34:23of these variables taking together.
34:25So, uhm.
34:28This is conclusions,
34:29but I want to leave time for some
34:32discussion because I think there's a
34:34lot a lot of things here issues to bring up.
34:37We concluded that cognitive
34:39behavioral therapy has sustained
34:41effects on insomnia severity,
34:43sleep quality, latency, and efficiency.
34:46It also improved fatigue,
34:48excessive daytime sleepiness,
34:50and six minute walk,
34:51and these were not only clinically
34:54but statistically significant.
34:56And again, you know, in heart failure.
34:59You may say, well,
35:00who cares if we improve the insomnia,
35:02but we didn't do anything to change
35:04their standard heart failure treatment
35:06and we were able to improve their
35:08fatigue in their six minute walk.
35:10Although there was a smaller
35:11improvements in the heart failure,
35:13self management.
35:14These were not mostly clinically significant.
35:17So.
35:21So. So in addition to this,
35:25why is insomnia important to heart disease?
35:29So doctor Javaherian Redline published
35:32a very nice review and chest in 2017
35:36about the role of insomnia in predicting
35:39adverse cardiovascular events.
35:41And there's some interesting data
35:44suggesting that not only does it it
35:47predicted incident heart failure in a
35:49population based study in Scandinavia.
35:51On the other hand,
35:53it did not predict echocardiography
35:54back cardio, graphic indices.
35:56There's some evidence that it that,
36:00of course we know that dementia and
36:02alter cognition are more important.
36:03In in are very important in heart failure,
36:07some evidence about cognition,
36:09our data showing symptoms
36:10and functional performance,
36:12and so it feels like insomnia
36:14is a really important target.
36:17The treatment,
36:17though you know a lot of our patients,
36:20were on medication.
36:21Heart failure patients might be on an
36:23average of eight to 10 different medications,
36:25so we really want to add to that
36:27polypharmacy and there's some
36:29evidence that benzos and we don't
36:30use those a lot anymore,
36:32but they also have adverse
36:34cardiovascular effects.
36:35So in some I would conclude that
36:38insomnia treatment is important.
36:40This is and this is one example of the
36:44Kaplan Meier curve from the log log
36:47stand study in Scandinavia showing the
36:49number of insomnia symptoms and showing.
36:52Event free survival now.
36:54I don't believe that this study was
36:56controlled for sleep disordered breathing,
36:58but we see a really strong
37:01predictive potential here.
37:03So the other thing to bring
37:05up as a point of discussion,
37:08and this is a nice slide from
37:10Tarek Ahmad here at Yale,
37:11in which he reviewed the biomarkers of.
37:16You know heart, heart,
37:18heart failure biomarkers,
37:19write novel biomarkers of heart failure,
37:21but if we go through these,
37:22a lot of these are linked with insomnia
37:25as well as some other sleep disorders.
37:27C reactive protein, for example,
37:29inflammatory processes, cytokines.
37:33Troponins,
37:33neurohormonal aspects and so
37:36a question might be asked.
37:39We did we improve the behavioral aspects.
37:42We improved insomnia,
37:43but to what extent?
37:45Might this treatment also improve
37:46some of this pathophysiology and
37:48I think we're we're not there yet,
37:50but I think it's important question.
37:52So we did actually write a supplement
37:54to our study and this is the same
37:57model you saw before in which we added
38:00some biomarkers of inflammation,
38:02neurohormonal.
38:03Activation heart failure,
38:05disease progression as well as
38:08some sleep regulatory variables.
38:09Things like BD and F41.
38:12And we we haven't yet. We have the.
38:15We've collected the samples but
38:16we haven't yet analyzed that,
38:18so that's to be determined.
38:19But I just wanted to put that in
38:21there that we improved behavior,
38:22but the and and we improved functional
38:25outcome. But the question is what?
38:27How did that happen?
38:28Was it just behavior or was there
38:31some biology associated with it?
38:33Soum
38:37what we can conclude here.
38:39So here's the challenge we about.
38:41We know that a large percentage of people
38:43with heart failure have also have moderate
38:46to severe sleep disordered breathing,
38:48and we know that they probably,
38:51although there's the,
38:52there's a lot of null trials and
38:54heart failure with PAP therapy.
38:56They have both.
38:57They have insomnia,
38:58and they have sleep disordered breathing,
39:00and so which should we?
39:02What should we read first?
39:04What level of sleep apnea
39:05do we need to treat?
39:06Should we be treating them together?
39:09Because we will,
39:09we screened out an awful lot of
39:11people because they had sleep
39:12disordered breathing and maybe
39:13we could have helped them.
39:15But the comment the current practices
39:17to treat the sleep apnea so so
39:19how should we think about that?
39:21And what should a new trial look like?
39:24We screened a lot of people
39:25and sent them for CPAP and even
39:26after we screen them they didn't
39:28want to use their seat path.
39:29So this adherence question
39:30is an important one.
39:32We ran our intervention
39:33as a face to face group,
39:35which again I'm glad we were
39:37really done before the pandemic.
39:39But that was very hard to do and may
39:43not be practical in the real world situation.
39:45So could we go to an app based approach,
39:48although we or their patients in
39:50our study also really appreciated
39:52the group the group approach they
39:54they bonded with each other.
39:56There was some social support there.
39:58Could we be doing this as online telehealth?
40:00Interestingly enough,
40:01a lot of the older participants
40:03in this study early on,
40:04we actually gave them an inexpensive
40:07tablet computer and ask them, you know,
40:11they told them they could log on
40:12like that if they couldn't come to the group,
40:15and most of them didn't
40:16want to use the tablet.
40:16They gave them to their grandchildren.
40:18So I think that's changed
40:20with Tele Health and so,
40:22how could we incorporate this
40:23into heart failure,
40:24disease management,
40:25perhaps with Tele health,
40:26perhaps?
40:27Would have been act because the
40:29face to face is probably not.
40:31Reasonable or feasible,
40:32and then the final question,
40:34which I mentioned briefly,
40:36is what are the biological mechanisms
40:38by through which this might work?
40:43So I did want to.
40:45This has been I've sort of was asked
40:47to talk about this particular trial,
40:49but I did want to give you some
40:51context and for me this has been a,
40:53you know, a 21 year effort in
40:57three different institutions,
40:59and so I wanted to thank or
41:02collaborators and staff that that
41:04were instrumental earlier in the day.
41:07Some of us were having a conversation
41:08about how to follow up people
41:10and keep them in the study and.
41:12You know, we we often give
41:14credit to our collaborators,
41:15but we don't often enough give credit to
41:17those people that may have us be successful,
41:20especially with studies of
41:21such a sick group of of people.
41:24So I wanted to thank our many
41:27collaborators and also to the
41:29many students and trainees that
41:31worked with us along the way.
41:32And some of these early on were
41:34back Glory students and nursing
41:36at master students in nursing.
41:38I had PhD students.
41:40I have a few psychologists in here.
41:42And so this has been really,
41:45klar likes to talk about sleeping in
41:48inherently interdisciplinary field,
41:50but I think that's certainly I'd like
41:53to underscore that here in this talk.
41:55Anyway,
41:56I hope we have some time for some questions,
41:59thank you.
42:04Hi Nancy, thank you very much for for
42:07this interesting journey into treatment
42:10of insomnia and people with heart failure.
42:12And we as we all know, in practice medicine.
42:15We know that patients with heart failure
42:17have a lot of suffering to go through and
42:19so alleviating even a little bit might be a
42:22very meaningful contribution to their life.
42:24And so I think I please.
42:27Those in the audience.
42:28Please post your questions to the chat or.
42:32You can simply ask to be unmuted.
42:33I'd be happy to help you with that,
42:34and I do have a question I was
42:35hoping to ask you, Nancy, and so,
42:38as you mentioned.
42:39You know that that heart failure
42:41and heart failure, individuals,
42:42insomnia and sleep disordered
42:44breathing coexist, and in fact,
42:46we know that even in the non heart
42:48failure populations up to 1/3
42:50of individuals with sleep apnea
42:52present with insomnia symptoms,
42:54whether they're middle or early
42:55or late type of insomnia.
42:59We also know that it's some recent
43:01clinical trials using CBT in
43:03individuals with sleep apnea Co
43:05currently or before C PAP therapy
43:06improves in here ends and quality of
43:09life and functional outcomes and so.
43:12You know, just wondering,
43:13what are your thoughts on you know,
43:15as you think to the future,
43:16what would be your thoughts on including.
43:21People with sleep disordered
43:22breathing in these trials and and
43:24what what you consider being
43:25the intervention in this case.
43:28Yeah, I mean so. We've and we've
43:30talked about this a lot, right?
43:32So I had to screen out people because
43:34the standard practice is to treat people
43:36with moderate right at least moderate,
43:38mild to moderate sleep apnea.
43:40I think they should have both.
43:41I can't answer the question of which
43:43we do first, second, and third.
43:45I think that at least one of the trials.
43:48I forget which one,
43:49but at least one of the other trials
43:50treated one and then the other.
43:52I mean, maybe maybe if you treat insomnia,
43:54you're going to get better CPAP adherence.
43:58Although you know I,
43:59I think that's that remains to be seen.
44:01I don't know which comes first,
44:03but I definitely think we need to treat both.
44:06Yeah, I know it's it's a.
44:08It's a good point I.
44:08I think in in the in the general
44:10literature it's if you treat
44:12them simultaneously or they
44:13treat insomnia before or let's
44:15say the outcomes are better than
44:17yeah. I mean that would
44:18be my suggestion again.
44:19I mean again I you know I had to
44:21convince NIH reviewers and clinicians of
44:23this and it was a while back where we
44:25were just treating everybody you know.
44:27And so there's a you know question of
44:30what's good medical practice right?
44:33And I guess if somebody is really
44:35severe with their apnea, you got it.
44:37You better treat them 'cause
44:38it's the safety question, right?
44:39It's bad for their heart
44:40if you don't treat them.
44:41So I think that where the fuzzy
44:43line is and even in our study we
44:46originally set out with a lower
44:48ahi of around 10 and we ended up
44:50going up to 15 because we couldn't.
44:52We didn't have anybody to be in the trial,
44:54and so where's the line between
44:57being not safe?
44:58Although a lot of these people are work
45:00walking around with sleep apnea for
45:01a long time before we even see them.
45:03So I guess to me it's like the safety
45:05issue of which do you treat first?
45:08Yeah or simultaneous right?
45:09And so yeah, a message from a
45:12comment from Doctor Gary is.
45:14Thank you for the great talk.
45:15I like the idea of concurrently
45:17treating insomnia and OSA,
45:18particularly if the sleep
45:20psychologists conducting the CBT.
45:22I can help with habituation
45:23and coaching around Pampus
45:25even group coaching for I
45:27think that's great.
45:28I think the other point is that
45:30you know we had a control group
45:32that included heart failure,
45:33disease management and we showed some
45:35improvement in that group and it's.
45:38Possible that for people with
45:40low levels of poor sleep or or
45:43insomnia that that might be enough,
45:45you know, sort of in a stepped
45:47care approach to insomnia,
45:49but the other point that was
45:51interesting and this is not to
45:53be negative about any any system,
45:55but all the patient.
45:56Most of the patients we were
45:58recruited were coming from really
46:00well established heart failure
46:02disease management programs and
46:03we were very surprised at how
46:05much they felt like they benefited
46:07from our control condition.
46:09So I would argue that not
46:10only do they need this,
46:12not only the disease management
46:14in terms of the medical part,
46:16but the self care part that the
46:18patients need to do that also
46:19needs to be combined with the
46:21insomnia and the PAP treatment.
46:23Right,
46:23because we saw some improvements there,
46:26right?
46:26If you're fluid overloaded because
46:27you're not taking your diuretics
46:29or you're eating too much sodium,
46:31you're going to have both.
46:32You know you're going to have
46:33more sleep to sort of reading
46:35as well as insomnia.
46:36So.
46:37You know, thank you. Let's see.
46:40There's a question from Doctor Yagi.
46:43First of all, great talk and
46:45can you speak to any evidence of
46:46circadian rhythms being impaired
46:48in people with heart failure?
46:50So we did, not.
46:51That was not a primary part of this study.
46:53However, we have many, many, many,
46:55many actigraph files in these patients now.
46:58Actigraphy is not a clean measure
47:00of circadian rhythm because we
47:02have external you know external,
47:04but we will be analyzing that.
47:06And we do have a paper.
47:08Yeah, which published from our earlier
47:11cross sectional data showing that.
47:13Disrupted rhythms based on the actigraphy
47:17data rest activity rhythms were closely
47:20aligned with depression and fatigue right.
47:24Whether this is cross sectional.
47:26So in this new study and we also have,
47:28we did get another supplement for this.
47:31Looking at the extent to which those
47:33rest activity rhythms predict outcomes.
47:35So we we haven't finished analyzing that yet,
47:38but and that's not a pure circadian measure.
47:41We also know melatonin is often.
47:43Abnormal and and and low melatonin is
47:45as a negative effect in heart failure,
47:48so I think that's another important
47:49way to go.
47:49But Claire,
47:50I don't have the answer on that yet,
47:52great thank you. Another question.
47:54Slash comment in great work
47:56and is there a way to get CBT?
47:58I covered by insurance and
48:00what are the best ways to get
48:02this treatment to our patients?
48:03So the question from Ian,
48:04we're from Norwalk. Well,
48:06that's a good question.
48:07I thought that we it was covered.
48:09I don't think it's covered very well.
48:11I mean for these pay I mean
48:12for anybody with insomnia,
48:13I thought we could get coverage.
48:14I mean, I don't do the billing,
48:16I just do research,
48:17right? Yeah, and so I,
48:18I think maybe I can address that a
48:20little bit and I think there are
48:22certain insurances that do coverage and.
48:25In private and also I believe in Medicare,
48:28but I can have somebody
48:29colleagues coming in this as well.
48:31But yes, it's a certainly is not
48:33covered as well as it can be.
48:35Let's see, Doctor Robert Thomas
48:37has a question in a statement.
48:39So C Pap alone does not cut it for
48:40the majority of these patients who
48:42have some combination of fragment
48:43and sleep and high loop gain which
48:45can amplify each other and so
48:47sensible CBT needs to be combined
48:49with multimodal apnea therapy.
48:51And so this is going back to this
48:53comment that really multimodal?
48:55Directly similar to the way we
48:57treat diabetes and and medically
48:59treat heart failure.
49:01Might be helpful here,
49:03and then another comment from Doctor Dre.
49:05Harry is do you think ISI should
49:07be administered in the cardiology
49:08clinic for all our failure patients?
49:10Absolutely,
49:12I I absolutely do.
49:13And at one point one of the clinicians
49:15left but I was trying to even if not ISI,
49:18at least some sleep quality measure.
49:20I don't know. We were working
49:22on getting that into Epic.
49:23I'm not sure where it stands over here,
49:24but yeah, yes, absolutely
49:27yeah, right and so then we have
49:28to figure out what are we going
49:29to do with that information and
49:30how do we help these individuals.
49:32So that goes back to Doctor.
49:34I think it also goes to
49:35educating the cardial.
49:36I mean, I we've done come along
49:38way right in terms of educating
49:40the cardiology community,
49:41but I do have to say I've been
49:44working with some folks who.
49:45We'll talk again.
49:46See Reticker study of sleep apnea.
49:48And it's not only Nancy Rediker study,
49:51but but my study was really
49:53about insomnia, right?
49:54So I think there's still a lot of
49:56a lot of lack of knowledge among
49:59the broader medical community about
50:01one sleep disorder versus another.
50:06Let's see and and so there is
50:08another question from Brendan Buck
50:10Crawford following up to the previous
50:12questions can CBT I also improve
50:14HI in heart failure patients if
50:17we consolidate sleep there will be
50:20less unstable non REM sleep less.
50:22App and transitional states which
50:23can lead to less periodic breathing
50:25and central events in heart
50:26failure patients question
50:27mark. So I actually think so.
50:29And some of you may know David
50:32Rappaport and he was my mentor for
50:34my K award and this was many many
50:36years ago and I brought that up and
50:38I thought he was going to look at me
50:40like I had two heads and he said yes.
50:41Of course if we get people into more
50:44stable sleep we might improve their.
50:46Hi I. We we we need to try it
50:50right now and there is a there's a
50:53little bit of data from one of those
50:55CBT and sleep apnea individuals where
50:57they hi declined by about seven
50:59and a half and in small groups.
51:02So there's certainly a signal for
51:05that in prior work as well so.
51:08And so Nancy could just speculate
51:09a little bit about the potential
51:11mechanisms by which.
51:14CBT I can improve
51:15so we have some additional data
51:17which I didn't present here so one
51:19there is a behavioral mechanism right
51:21we we looked at these perpetuating
51:24thoughts and thoughts about sleep.
51:26We measured those thoughts which
51:28but but they're psychological.
51:29Their perceptions, right?
51:30But they also can be related to physiologic,
51:33you know psychological and
51:35physiological arousal or not separate
51:38necessarily phenomena. And we did.
51:40We published a paper from our feasibility
51:42or early study which showed that.
51:44That that the treatment effect,
51:46at least on insomnia and fatigue,
51:48was mediated by some of
51:49those thoughts and ideas.
51:51You know, this catastrophizing and so forth.
51:54We have similar data which I do present
51:56here today from this and and or the paper
51:59that we just got accepted talks about that.
52:01But I do think there's an error out that the
52:05Physiology you know that it's inflammatory.
52:07We've got a route.
52:08We've got sympathetic arousal
52:09and insomnia as well,
52:10known to be a sympathetic process,
52:13and so I think that's.
52:14A large part of it,
52:15as well as inflammation,
52:17and so just just thinking about the
52:20intervention they have provided.
52:21Could you perhaps, you know,
52:23summarize the resources needed to
52:25intervene on the individual patient?
52:27For example, what would it?
52:28What would it cost to the practice to bear?
52:31Bring this to clinical side.
52:33Well, I think this would be no different.
52:35I mean, I mean you have we have
52:38behavioral Sleep Medicine here at
52:39Yale and other centers do as well.
52:42It's exactly the same treatment.
52:44Ray, all we did was deliver it in a
52:47specialized in a in a special setting
52:49only to heart failure patients and
52:51so and we did it in a group format so
52:53other people have done a group format.
52:55Other people have done individual
52:56face to face.
52:57I mean increasingly we're seeing
52:58Tele health and apps.
52:59The question is whether these very
53:02sick patients would be interested
53:04or able to do it that way.
53:07I mean our challenge is getting them
53:09all out and scheduling a group that
53:11would be the part that's less feasible.
53:14And then that's a question.
53:15Is do we you know,
53:17would they equally benefit from these other,
53:19you know, individual or app bait you know?
53:22And that's a that's a scientific question.
53:25We kind of knew that what we were
53:27doing was a little cumbersome,
53:28but all our preliminary data was based
53:30on that and the patients liked it.
53:32So we did.
53:33But now we're left with OK,
53:35how do we actually go out and implement this?
53:37How do we make it more streamlined for
53:40the particularly the heart failure setting?
53:42We are doing some,
53:43by the way,
53:43we're doing some additional qualitative.
53:46Focus group work with providers in
53:48heart failure programs of various
53:50sorts to to ask their opinions
53:52about how they might do this.
53:54To get that to happen.
53:56Well, wonderful wonderful body of work.
53:59Well, thank you so much Nancy for this
54:02wonderful talk and the lively discussion.
54:05And thank you everyone for
54:07participating in today's session.
54:08And this was our last session for 2021,
54:12so thanks everyone for making
54:13this a success and we will be back
54:15in January with another session
54:18sponsored by Boston Medical Center
54:20and so have a great afternoon.
54:22Have great holidays and we'll
54:24talk next month. Thank you.