bluuebunny/crossref_metadata_2025 huggingface dataset:
0443 Intra Week Sleep Patterns Analyzed Using Consumer Sleep Tracker Data
Authors: Gahan L , Ruder M , Raj A , O’Mullane B , Raymann R J
Published: May 2020

Introduction

Big data collected using consumer sleep technology can provide objectively measured insights on sleep behavior in the real-life environment. It has the advantage over self-report data of being less prone to bias. Here we used a non-contact bio-motion sensor to remotely capture objective sleep data. We analyzed 168432 nights of sleep data to test if differences between weekday versus weekend sleep behavior, known from self-report, would still hold using objective data in a large population.

Methods

Sleep data was acquired using the SleepScore Max remote sleep sensor and included 168432 nights (2730 users, mean age: 46.6 +/- 11.8 years, 33% female, all resident in the USA). Analysis was restricted to those of working age; adults between 20-65. Any sleep which ended from Monday to Friday was considered weekday sleep, and any ending on Saturday or Sunday as weekend sleep. Data records were inspected and cleaned before analyzing. Descriptive statistics and independent t-tests were used to analyze the data.

Results

Total Sleep Time, Time In Bed and Sleep Onset Latencies were longer during weekend (TST: + 20.6 mins, TIB: +22.9 mins, SOL: +1.1 min, all p <0.001), resulting in a slightly poorer Sleep Efficiency (-.016%, p<0.01) for weekend nights. Time to bed and final awakening were both delayed in weekends as compared to weekdays (Time to bed +30.0 mins, and final awakening +53.4 mins, both p<0.001).

Conclusion

This big data analysis confirms the earlier observed difference in sleep and sleep behavior between weekdays and weekends. This should be considered for optimizing (automated) sleep interventions, that may not normally take the weekend effect into consideration.

Support
0459 Is It Having a Baby or Me? Differentiating Insomnia Disorder and Sleep Disruption from Pregnancy to 2 Years Postpartum
Authors: Quin N , Lee J , Pinnington D M , Shen L , Manber R , Bei B
Published: May 2020

Introduction

Insomnia Disorder (Insomnia) diagnosis requires sleep complaints to persist despite “sleep-conducive conditions and adequate sleep opportunity”. Women experience significant sleep disruption during pregnancy and postpartum periods due to physiological changes and night-time infant care, but not all women with sleep complaints meet Insomnia criteria. This study examined sleep and mental health correlates of Insomnia Disorder and sleep complaints in the context of a randomised controlled trial for improving maternal sleep.

Methods

163 generally healthy first-time mothers (age M±SD=33.4±3.5) with singleton pregnancy repeated the following assessments at 28-30 and 35-36 weeks’ gestation, and 1.5, 3, 6, 12, and 24 months postpartum: the Insomnia module of the Duke Structured Interview for Sleep Disorders, PROMIS Sleep-Related Impairment, Depression, and Anxiety Short Forms. We compared clinical features when DSM-5 Insomnia criteria (less the 3-month criteria) were (1) met (Insomnia), (2) not met only because of the sleep condition/opportunity criteria (Sleep Disruption), and (3) not met due to low symptom/distress (Low Complaint).

Results

944 interviews and 1009 questionnaire were collected across 7 time-points. Proportions of women meeting Insomnia criteria were 16.0% and 19.8% during early and late third trimester, and ranged 5.3-11.7% during the 5 postpartum time-points. If the sleep condition/opportunity criteria were not considered, rates of “Insomnia” would have been 2-4 times higher at 21.4-40.4% across all time-points. Mixed effects models, controlling for intervention allocation, showed that compared with Insomnia, Sleep Disruption had comparable depression (p=.68) and anxiety (p=.23), and somewhat lower sleep-related impairment (p=.06). These symptoms were lowest for Low Complaint.

Conclusion

Both Insomnia and Sleep Disruption were associated with significant daytime impairment, depression, and anxiety. Assessing sleep complaints without considering sleep condition/opportunity can result in over-diagnosis of perinatal Insomnia in these women with primarily sleep disruption; these women may have limited benefits from Insomnia-specific treatment. Interventions for maternal sleep should carefully differentiate between Insomnia and other sleep concerns (e.g., sleep disruption/opportunity, sleepiness/fatigue) and appropriately address each.

Support

Australasian Sleep Association, Monash University, Royal Women’s Hospital Foundation. National Health and Medical Research Council, Department of Education and Training.
0470 A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia in Pregnant Women
Authors: Kalmbach D A , Cuamatzi-Castelan A , Tonnu C V , Roth T , Sangha R , Swanson L M , O’Brien L M , Drake C L
Published: May 2020

Introduction

Over half of pregnant women experience clinical insomnia, which is linked to perinatal depression and cognitive-emotional dysregulation. Despite high rates of prenatal insomnia and known maternal consequences, efficacious insomnia treatment options for this population are woefully scant. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy digital CBTI via mobile health app in pregnant women with insomnia.

Methods

Single-site RCT. Ninety-one pregnant women (29.03±4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. Blinded assessments were performed before treatment, after treatment (during pregnancy), and 6 weeks after childbirth. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale’s Cognitive factor (PSAS-C) served as study outcomes.

Results

From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p<.001) and PSQI (-2.98 points, p<.001) and increases in nightly sleep duration by 32 minutes. Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 minutes per night (p=.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.

Conclusion

Digital CBTI improves sleep quality and increases sleep duration during pregnancy and after childbirth. Digitally delivered interventions have potential to improve the health of new and expectant mothers, but CBTI likely needs to be tailored for perinatal patients to optimize outcomes.

Support

This study was funded by the American Academy of Sleep Medicine (198-FP-18, PI: Kalmbach).
0475 Reducing Dysfunctional Sleep-Related Cognitions Improves Nighttime Sleep and Daytime Consequences in Older Adults with Insomnia
Authors: Song Y , Kelly M R , Fung C H , Dzierzewski J M , Grinberg A , Mitchell M N , Josephson K , Fiorentino L , Martin J L , Alessi C A
Published: May 2020

Introduction

The long-term impact of addressing sleep-related cognitions, which is an important component of cognitive behavioral therapy for insomnia (CBTI), has not been established, particularly in older adults. We examined whether specific changes in sleep-related cognitions predicted long-term changes in sleep and other outcomes following CBTI in older adults.

Methods

We analyzed data from a randomized controlled trial testing CBTI in older veterans with insomnia (N=159, mean age 72 years). Sleep-related cognitions were assessed with the Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS, subscales: Consequences, Worry/Helplessness, Sleep Expectations, Medication). Outcome measures included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), sleep diary variables, Flinders Fatigue Scale (FFS), and Short Form-12 health-related quality of life (QOL). Analyses completed slope of change in DBAS subscales (baseline to post-treatment: T1) between CBTI and control with respect to slope of change in sleep and other outcomes from post-treatment to 6-months (T2).

Results

Compared to controls, the CBTI group had significantly stronger associations between improvement (T1) in DBAS-Consequences and subsequent (T2) improvement in PSQI (difference in slopes [DIS]=0.9, 95%CI=[.29, 1.43], p=0.004), ISI (DIS=1.1, 95%CI=[.18, 2.0], p=0.019), ESS (DIS=0.6, 95%CI=[.10, 1.18], p=0.020), and FFS (DIS=1.9, 95%CI=[.76, 3.09], p=0.001). The CBTI group also had significantly stronger associations between improvement in DBAS-Worry/Helplessness and subsequent improvements in PSQI, ISI, and FFS; improvement in DBAS-Medication and PSQI and ISI; and improvement in DBAS-Sleep Expectations and improved FFS. Slopes were not different between groups for sleep diary variables or QOL.

Conclusion

Significant improvements in sleep-related cognitions with CBTI across DBAS subscales in older adults predicted improvement in several outcomes of nighttime sleep and daytime consequences. These findings suggest the importance of addressing dysfunctional sleep-related cognitions for sustained improvement with CBTI in older adults

Support

The study was supported by VA Health Services, Research and Development (Alessi, IIR 08-295), National Institute on Aging (K23AG055668, Song), National Heart, Lung, and Blood Institute (K24HL 143055, Martin) of the National Institutes of Health and VA Greater Los Angeles Healthcare System, Geriatric Research, Education and Clinical Center.
0480 Efficacy and Safety of Lemborexant in Female Subjects of Perimenopausal Age with Insomnia Disorder
Authors: Cheng J , Yardley J , Pinner K , Moline M
Published: May 2020

Introduction

Insomnia is common in women in the perimenopausal age range. We present 12-month efficacy and safety data for the subgroup of female subjects in the age range associated with perimenopause (age 40-58y) from SUNRISE-2 (NCT02952820; E2006-G000-303).

Methods

SUNRISE-2 was a 12-month, randomized, double-blind, placebo (PBO)-controlled (first 6mo [Period 1]), global phase 3 study. During Period 1, subjects received PBO or lemborexant (LEM: 5mg, [LEM5]; 10mg, [LEM10]). During Period 2 (second 6mo), LEM subjects continued their assigned dose. PBO subjects were rerandomized to LEM5 or LEM10 (not reported here). Changes from baseline in subjective sleep parameters: subjective sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO) were assessed from sleep diary data.

Results

The perimenopausal subgroup comprised 280 subjects (Period 1: PBO, n=90; LEM5, n=82; LEM10, n=108). Baseline median sSOL (min) was 57.5, 51.1, and 54.0 for PBO, LEM5, and LEM10. Greater median decreases from baseline in sSOL (min) occurred at 6mo with LEM vs PBO (PBO, −17.9; LEM5, −20.7; LEM10, −30.4); improvements persisted at 12mo (LEM 5, −27.7; LEM10, −33.9). Baseline mean[SD] sSE was 59.9%[16.6%], 60.7%[20.0%], and 61.2%[17.5%] for PBO, LEM5, and LEM10. Greater mean[SD] increases from baseline in sSE (%) occurred at 6mo with LEM vs PBO (PBO, 12.5%[15.0%]; LEM5, 15.9%[17.0%]; LEM10, 17.2%[14.7%]); improvement persisted at 12mo (LEM5,17.6%[18.2%]; LEM10, 19.1%[14.8%]). Baseline mean[SD] sWASO (min) was 134.9[70.8], 142.4[86.5], and 136.5[84.4]. Greater mean[SD] decreases from baseline in sWASO (min) occurred at 6mo with LEM vs PBO (PBO, −37.0[59.6]; LEM5, −50.1[74.5]; LEM10 −54.5[65.4]); improvement persisted at 12mo (LEM5, −59.1[76.7]; LEM10, −66.2[64.9]). Most treatment emergent adverse events (TEAEs) were mild/moderate.

Conclusion

Consistent with previously reported data from the total population, subjective sleep parameters improved, and improvement was sustained over time in perimenopausal women. LEM was well tolerated, supporting LEM as a potential treatment option for perimenopausal women with insomnia.

Support

Eisai Inc.
0484 How Much Improvement in Subject-Reported Sleep Onset Latency is Needed for Patients to Report a Positive Impact of Their Insomnia Medication?
Authors: Drake C , Yardley J , Pinner K , Perdomo C , Kumar D , Moline M
Published: May 2020

Introduction

How much improvement would be considered meaningful from the patient perspective is not well defined. In SUNRISE-2 (NCT02952820; E2006-G000-303), using the Patient Global Impression-Insomnia version (PGI-I), subjects rated how treatment impacted subjective (sleep diary-based) sleep onset latency (sSOL; Question2; positive, neutral, and negative) relative to before starting treatment. Meaningful change can thus be determined based on the change from baseline (CFB) in subjects with a positive score.

Methods

SUNRISE-2 (n=949, full analysis set) was a Phase 3, 12-month, double-blind, global study in subjects age ≥18y with insomnia disorder. Subjects received PBO (N=318), LEM 5mg (LEM5, N=316) or LEM 10mg (LEM10, N=315) for 6 months. At the end of Month 6, PBO subjects were rerandomized to LEM5 or LEM10; LEM5 and LEM10 subjects continued at the same dose for 6 more months. The ranges of median CFB in sSOL (minutes) at 6 months were examined in response to PGI-I Item 2.

Results

At 6 months, subjects reporting positive medication effect (PBO, n=110; LEM5, n=178; LEM10, n=159) showed median CFB in sSOL from -17.5 to -32.1 minutes across treatment groups. In subjects reporting neutral effect (PBO, n=49; LEM5, n=28; LEM10, n=27), median CFB in sSOL ranged from -10.4 to -25.6 minutes across treatment groups. In subjects reporting negative medication effect (PBO, n=82; LEM5, n=34; LEM10, n=32), median CFB in sSOL ranged from -8.6 to -10.4 minutes across treatment groups. The PBO group provided the smallest numbers for each response category range.

Conclusion

Subjects reporting positive medication effect on PGI-I Item 2, i.e. decreased time to fall asleep, had corresponding changes from baseline in sSOL ranging from -17.5 to -32.1 minutes. Thus, this range may represent a clinically meaningful improvement as perceived by patient-subjects, and may be useful to clinicians in determining whether a treatment regimen is working for their patients.

Support

Eisai Inc.
0492 Sleep and Hyperarousal: Inability to Discontinue Chronic Hypnotic Use
Authors: Roehrs T , Koshorek G , Verkler J , Roth T
Published: May 2020

Introduction

Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical concern. Sleep and hyperarousal was examined in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication after 6 months of nightly use.

Methods

DSM-V diagnosed people with insomnia (n=31, 26 females), aged 23-61 yrs, with a polysomnographic sleep efficiency (SE) of ≤85% on a 8-hr polysomnogram, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency have completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg as capsule 1, 6.25 mg as capsule 2, placebo as capsule 3; eszopiclone 2 mg, 1 mg, and placebo as capsules 1, 2 and 3 respectively; or 3 placebos.

Results

Fifteen subjects stopped taking study medication when told to discontinue. The other 16 subjects who took study medication (users) had longer MSLT (a measure of hyperarousal) sleep latency (16.2 vs 8.3 min) than non-users (p<.001) at baseline. At baseline users and non-users had similarly disturbed nocturnal sleep: SE 73.4 vs 73.9 %, with sleep latencies of 54 vs 40 min and wake time after sleep onset of 90 vs 104 min.

Conclusion

Hyperarousal, defined by MSLT and high diurnal urinary cortisol levels, has been found in some people with insomnia. High MSLTs were previously associated with dose escalation in a chronic zolpidem use study. These emerging data would suggest high MSLT may also be predictive of difficulty discontinuing hypnotic use.

Support

NIDA, grant#: R01DA038177 awarded to Dr. Roehrs
0494 Ability to Discontinue Chronic Hypnotic Use: An Update
Authors: Roth T , Koshorek G , Verkler J , Roehrs T
Published: May 2020

Introduction

Physicians prescribing hypnotics remain concerned regarding patient’s inability to discontinue hypnotics after chronic use. That concern has never been directly tested in a controlled prospective study using self-administration choice procedures. This is an update on results from an on-going “blinded” clinical trial in which insomnia subjects are instructed to stop taking their study medication after 6 months of nightly use.

Methods

DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=31, 26 females), with disturbed sleep (i.e., polysomnographic sleep efficiency of ≤85%), no other sleep disorder, unstable medical or psychiatric diseases or drug dependency completed the trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos).

Results

The number of capsules taken declined from week 1 to 2 (p< .001). Over the 2 weeks 15 participants took 0 (48%), 12 ≤ 6 (39%) and 4 ≥10 total capsules (1 each took 42, 19, 13, and 10). Among those taking capsules, most took one capsule per night and 6 took > 1 capsule. Those 4 taking ≥ 10 were younger (p<.05), but did not differ in screening sleep efficiency or blinded treatment group. Importantly 1 subject took every capsule available.

Conclusion

The majority (87%) of the participants discontinued 6-month nightly hypnotic use (i.e. took ≤ 6 total capsules) and among those taking capsules the rate declined from week 1 to 2. Age may help identify the few with difficulty discontinuing.

Support

NIDA, grant#: R01DA038177 awarded to Dr. Roehrs
0503 Reductions in Sleep and Daily Rhythm Variability Following Brief Behavioral Treatment for Insomnia
Authors: Kanady J C , Straus L D , Gloria R , Neylan T C , Maguen S
Published: May 2020

Introduction

Brief behavioral treatment for insomnia (BBTI) is efficacious for insomnia symptoms. Here we examine whether BBTI reduces sleep and daily rhythm variability and whether reductions in variability result in improved functioning and quality of life.

Methods

Ninety-one Veterans with insomnia (49.3±18.7yrs; 18.7% female) were randomized to one of two treatment conditions: BBTI or progressive muscle relaxation training (PMRT; control condition). Variability was assessed using sleep diaries and actigraphy. The sleep diary outcome variables included bedtime variability, wake time variability, and total sleep time variability; actigraphy variables included interdaily stability, intradaily variability, and total sleep time variability. Functioning was assessed using the Work and Social Adjustment Scale. Quality of life was assessed using the Hotel Dieu-16 Scale.

Results

Compared to PMRT, BBTI resulted in a greater reduction in subjective total sleep time variability (F1,90=6.61, p<0.01, partial η 2=0.13) and a greater increase in interdaily stability (F1,78=12.41, p<0.01, partial η 2=0.25). There was a greater decrease in intradaily variability following PMRT (F1,78=27.96, p<0.01, partial η 2=0.42). Across the entire sample, reductions in subjective wake time variability were associated with improved functioning (F1,88=4.43, p=0.04, η 2=0.05) and reductions in subjective total sleep time variability were associated with improved quality of life (F1,89=4.91, p=0.03, partial η 2=0.05).

Conclusion

There was significant improvement in the stability of sleep-wake rhythms following BBTI, suggesting that BBTI not only treats insomnia, but also may stabilize circadian rhythms. Interestingly, PMRT resulted in greater intradaily variability reductions than BBTI. One explanation is that due to BBTI stimulus control guidelines, individuals were getting out of bed in the middle of the night more frequently and thus, these awakenings were better captured by actigraphy. Reductions in wake time and total sleep time variability were associated with improved functioning and quality of life, further demonstrating the importance of stable sleep-wake rhythms.

Support

VA Rehabilitation Research and Development Grant # RX001539-01A2
0507 Mobile Cognitive Behavioral Therapy is Efficient in Improving Sleep in Students
Authors: Eyal S , Altman Y , Baharav A
Published: May 2020

Introduction

Academic achievements and social life on campus represent the main focus for students, while sleep is neglected. The emergence of social media, gaming reduces sleep opportunity, quality and ability. Students are sleep challenged and prone to develop chronic sleep difficulties in later life. Cognitive behavioral interventions are recognized as effective for insomnia and circadian misalignment. We aimed at detecting sleep difficulties, related habits, and at testing the efficacy of a mobile app in improving sleep in students with insomnia symptoms.

Methods

Observational study of US students who approached wellness staff and were offered the Refresh by Sleeprate mobile app that provides a sleep assessment followed by weekly cycles of personalized digital cognitive and behavioral reframing. The app collects perceived, and optional objective sleep data acquired using wearable devices. 892 students aged 18-30 years registered an account between Jan 1 and Oct 30, 2019. The study reports engagement data and outcomes of the assessment and the digital intervention.

Results

507 completed their assessment (6.2 avg nights). 69% presented insomnia symptoms with or without circadian misalignment, 8% circadian misalignment, 12% sleep deprivation, 11% poor sleep hygiene. 192 (55.3% of students with insomnia symptoms) completed at least one week of intervention (5.6 weekly avg nights, 28 avg total nights). Sleep Latency (SL) in minutes decreased from 28.8 (21.5) (Mean/SD) to 22.1 (19.3), p<0.001. When the initial mean SL was longer than 30 minutes, the improvement was larger, from 53.9 (20.8) to 32.7 (25.4) (p<0.001). Mean perceived Wake After Sleep Onset (WASO) longer than 30 minutes decreased from 46.3 (19.0) to 35.8 (21.4), p<0.05. Sleep Efficiency (SE) increased by 1.6% (p<0.002) for all, and by 7.1% (p<0.001) for SE<85%.

Conclusion

The mobile app used reveals sleep problems and is efficient in improving insomnia symptoms in those who remain engaged. 55% of those who started the program also completed it. Engagement remains the main barrier to sleep improvement at scale.

Support

N/A
0514 Efficacy of a Forehead-Cooling Device for Treating Insomnia in Veterans
Authors: Nofzinger E
Published: May 2020

Introduction

In 2 independent studies, we explored whether a forehead-cooling device was effective in improving insomnia in veterans.

Methods

Both studies were uncontrolled and exploratory in nature. The first study involved 20 veterans who expressed interest in using the forehead-cooling device and received 4 weeks treatment. The second study involved 19 veterans who were recruited via media to participate in a 4-week study and were compensated for their participation. All participants completed questionnaires before and after treatment.

Results

In the retrospective analysis, veterans had improvements over baseline in insomnia severity index (M ± SD =17.6 ± 4.7 pre- vs 6.9 ± 3.5 post-treatment, t(19) = -9.4, p<0.00001), in sleep latency (M ± SD = 61.7 ± 49.1 minutes pre- vs 25.0 ± 20.8 minutes post-treatment, t(19) = -4.6, p<0.001) and in minutes awake after sleep onset (M ± SD =78.7 ± 57.8 minutes pre- vs 29.9 ± 18.3 minutes post-treatment, t(19) = -4.0, p<0.001). In the prospective study, veterans had improvements in insomnia severity index over baseline (M ± SD = 20.7 +3.8 pre- vs 9.5 ± 7.5 post-treatment, t(18) = 5.8, p<0.00001), depression severity on the PHQ-9 (M ± SD = 21.5 ±6.1 pre- vs 14.2 ± 5.1 post-treatment, t(18) =4.1, p<0.001) and anxiety severity on the GAD 7 (M ± SD = 9.8 ±7.1 pre- vs. 6.2 ± 5.4 post-treatment, t(18) = -3.1, p<0.01).

Conclusion

Use of a forehead-cooling device improved insomnia in veterans. These findings were replicated in an independent prospective trial. Reductions in depressive and anxiety symptoms from baseline were also noted in the prospective study. These promising preliminary data suggest the need for further large scale randomized controlled trials to establish the efficacy of forehead-cooling on insomnia in veterans.

Support

Ebb Pharmaceuticals, Pittsburgh, PA 15222
0528 Insomnia as a Mechanism for Improvement in Alcohol Problems Among Young Adults
Authors: Miller M , Freeman L B , Park C J , Hall N , Sahota P K , McCrae C S
Published: May 2020

Introduction

More than half of heavy-drinking young adults report symptoms of insomnia, which have been associated with alcohol-related problems. This study examined improvement in insomnia (via Cognitive Behavioral Therapy for Insomnia; CBT-I) as a mechanism for improvement in alcohol-related problems.

Methods

Fifty-six heavy-drinking young adults with insomnia (ages 18-30y) were randomized to CBT-I (n=28) or single-session sleep hygiene control (SH; n=28). Of those, 43 (77%) completed post-treatment (24 SH, 19 CBT-I) and 48 (86%) completed 1-month follow-up (25 SH, 23 CBT-I). Multiple imputation was used to estimate missing data. Treatment outcomes were assessed using multilevel models. Mediation was tested using bootstrapped confidence intervals for indirect effects in the PROCESS macro.

Results

CBT-I participants reported greater decreases in insomnia severity than those in the sleep hygiene group [group X time interaction, F(2,59)=11.29, p<.001], both post-treatment and at 1-month follow-up. Both groups decreased significantly in diary-assessed sleep quality [time, F(2,55)=40.30, p<.001], with a marginally significant interaction in favor of the CBT-I group [F(2,55)=2.69, p=.08]. There were no significant group by time interactions in the prediction of actigraphy-assessed sleep variables, although again, there was a marginally significant interaction in the prediction of actigraphy-assessed sleep efficiency [F(2,66)=2.75, p=.07]. Both groups reported significant decreases in drinking quantity over time [time, F(2,58=13.88, p<.001]. However, CBT-I participants reported greater decreases in alcohol-related consequences than those in the sleep hygiene group [F(2,67)=4.13, p=.02]. In the mediation model, CBT-I did not have a direct effect on change in alcohol-related consequences (B=1.49, SE=1.06, 95%CI=-0.65, 3.62); however, it influenced change in 1-month alcohol-related consequences indirectly through its influence on post-treatment insomnia symptoms (B=-1.09, SE=0.57, 95%CI=-2.30, -0.05).

Conclusion

CBT-I is effective in treating insomnia among heavy-drinking young adults and may be associated with reductions in alcohol-related problems due to its impact on insomnia symptoms.

Support

This work was supported by funding from the University of Missouri System Research Board Office (PI Miller). Mary Beth Miller’s contribution to this project was also supported by the National Institute on Alcohol Abuse and Alcoholism [grant number K23AA026895].
0532 Cognitive Behavioral Therapy Delivered Via Telemedicine vs. Face-to-Face: Results from a Randomized Controlled Non-Inferiority Trial
Authors: Arnedt J , Conroy D , Mooney A , DuBuc K , Balstad S , Pace D , Yang A , Furgal A , Sen A , Eisenberg D
Published: May 2020

Introduction

Telemedicine is increasingly an option for delivery of healthcare services, but its efficacy and acceptability for delivering CBT for insomnia has not been adequately tested. In a randomized controlled non-inferiority trial, we compared face-to-face and telemedicine delivery (via the AASM SleepTM platform) of CBT for insomnia for improving sleep and daytime functioning at post-treatment and 12-week follow-up.

Methods

Sixty-five adults with chronic insomnia (46 women, mean age 47.2 ± 16.3 years) were recruited primarily from insomnia clinics and screened for disqualifying sleep, medical, and mental health disorders. Eligible participants were randomized to 6 sessions of CBT for insomnia delivered face-to-face (n=32) or via AASM SleepTM (n=33). Participants completed self-report measures of insomnia (Insomnia Severity Index, ISI) and daytime functioning (fatigue, depression, anxiety, and overall functioning) at pre-treatment, post-treatment, and 12-week follow-up. The ISI was the primary non-inferiority outcome.

Results

Telemedicine was non-inferior to face-to-face delivery of CBT for insomnia, based on a non-inferiority margin of 4 points on the ISI (β = -0.07, 95% CI -2.28 to 2.14). Compared to pre-treatment, ISI scores improved significantly at post-treatment (β = -9.02, 95% CI -10.56 to -7.47) and at 12-week follow-up (β = -9.34, 95% CI -10.89 to -7.79). Similarly, daytime functioning measures improved from pre- to post-treatment, with sustained improvements at 12-week follow-up. Scores on the fatigue scale were lower in the telemedicine group at both post-treatment (F=4.64, df=1,119, p<.03) and follow-up (F=5.79, df=1,119, p<.02).

Conclusion

Insomnia and daytime functioning improve similarly whether CBT for insomnia is delivered via telemedicine or face-to-face. Telemedicine delivery of CBT for insomnia should be implemented more systematically to improve access to this evidence-based treatment.

Support

American Sleep Medicine Foundation Grant # 168-SR-17 (JT Arnedt, PhD)
0533 Age and Education Level are Associated with Dropout from Cognitive-Behavioral Therapy for Insomnia in Participants with Co-Occurring Depression: A Report from the TRIAD Study
Authors: Dietch J R , Manber R , Buysse D J , Edinger J D , Krystal A
Published: May 2020

Introduction

Early termination (i.e., dropout) from cognitive-behavioral therapy for insomnia (CBT-I) likely attenuates benefits and may reduce motivation for future treatment. The aim of the current study was to identify characteristics of participants who dropped out of CBT-I in an RCT of combined treatment for depression and insomnia.

Methods

Participants were 148 adults with comorbid insomnia and depression diagnoses (73% female; M age = 46.6[SD = 12.6]) who were randomly assigned to receive depression pharmacotherapy plus 7 weekly sessions of CBT-I (n = 73) or a credible control therapy for insomnia (n = 75). Receiver operating characteristic curve (ROC) analyses were performed to determine which participant characteristics (i.e., demographics, baseline depression and sleep variables) predicted dropout at session 4 (i.e., minimum dose) and session 7 (i.e., full course of CBT-I).

Results

Early termination (prior to session 4) rate was 28% and ROC analyses indicated participants aged 36 or less were more likely to drop out than those older than 36 (49% vs. 22%). The model did not identify additional predictors for either of the two age categories. Overall termination (prior to session 7) rate was 45% and ROC analyses indicated participants aged 46 or less were more likely to drop out than those older than 46 (61% vs. 34%). The model further found that among participants aged 46 or less, those with less than 14y education were at greater risk for dropout than those with greater than 14y education (79% vs. 46%). No other demographic, depression, or sleep variables were significant predictors of dropout.

Conclusion

Age was associated with elevated rate of dropout from CBT-I among individuals with co-occurring depression and insomnia. It appears that the combination of younger age and lower education level is particularly detrimental to treatment engagement. Better understanding of factors that contribute to dropout from CBT-I in this vulnerable group can guide development of retention strategies.

Support

MH078924, MH078961, MH079256
0540 Insomnia Symptom Trajectories During and Following Combined Treatment for Insomnia and Depression: A Report from the Triad Study
Authors: Atwood M E , Dietch J R , Buysse D J , Edinger J D , Krystal A , Manber R
Published: May 2020

Introduction

Cognitive behavioral therapy for insomnia (CBT-I) reduces insomnia severity among individuals with insomnia and major depressive disorder (MDD). Understanding the long-term trajectories of insomnia symptom severity has the potential to inform optimization of CBT-I in this population. The objectives of this study were to examine trajectories of change in insomnia severity over a 16-week treatment phase and 2-year naturalistic follow-up, and explore correlates of symptom trajectories.

Methods

148 adults (age 46.6±12.6, 73.0% female) with insomnia and MDD were randomly assigned to receive depression pharmacotherapy plus seven sessions of either CBT-I or control insomnia therapy. Depression and insomnia severity were assessed via the Hamilton Depression Rating Scale and Insomnia Severity Index at baseline, bi-weekly during treatment, and every 4 months over follow-up. Sleep effort and beliefs about sleep were assessed at baseline, midtreatment, and posttreatment.

Results

Latent class linear mixed modeling revealed four insomnia response trajectories: 1) Early Sustained-Responders (16%) showed marked improvement early in treatment, sustained over follow-up; 2) Gradual-Responders (36.7%) achieved substantial symptom reduction by posttreatment, sustained over follow-up; 3) Initial-Responders (25.3%) had substantial symptom reduction during treatment but increased in severity over follow-up; and 4) Partial-Responders (20.7%) achieved minimal improvement over treatment, and maintained moderate symptom severity over follow-up. Chi-square analyses revealed that classes did not differ significantly on sex, ethnicity, employment, relationship status, or treatment received (all ps > .05). One-way ANOVAs with Tukey’s HSD, showed that Partial-Responders consistently endorsed higher depressive symptom severity, sleep effort, and unhelpful beliefs about sleep at baseline, throughout treatment, and follow-up (ps < .05). Early Sustained-Responders endorsed lower sleep effort by midtreatment (ps < .01).

Conclusion

Results suggest four temporal patterns of treatment response and identified clinical correlates. Future work will be needed to determine if addressing sleep effort early in the course of treatment might enhance sustained insomnia outcome.

Support

MH078924, MH078961, MH079256
0546 Sleep Science at Home - Delivering Sleep Assessment and Digital CBT-i at Scale
Authors: Arnal P J , Thorey V , Debellemaniere E , Mordret E , Llamosi A , Chouraki A
Published: May 2020

Introduction

Cognitive-behavioral therapy for insomnia (CBT-I) is the current first-line treatment for insomnia disorder, recommended by the AASM and SRS. Digital versions of CBT-I have been developed and validated to address the need for implementation at scale but still suffer from poor accessibility and compliance. Therefore, the aim of this open-label, Real-World Study (RWS) was to assess the engagement and efficacy of a next-generation CBT-i 6-weeks program.

Methods

1304 subjects were included in the analysis between Dec 23rd, 2018 and December, 14th 2019. The main inclusion criteria were having an Insomnia Severity Index ISI ≥ 15 and completion of one week of Dreem program. The variables have been measured by the Dreem headband (DH) for objective variables, and on subjects’ answers to questionnaires for subjective ones.

Results

The retention during this RWS was 70.4 % (Pre: n = 1304 and Week 4: n = 935). The program led to a clinically significant decrease of 7.42 points on the ISI (p < 0.001). The obj-WASO was reduced by 35% (n = 359, p < 0.001), obj-Awakenings were reduced by 37% (n = 359 p < 0.001), obj-SE was increased by 2.56 points (n = 305, p < 0.001) and obj-SOL was reduced by 22% (n = 359, p < 0.001). The subj-SOL was reduced by 41% (n = 176, p < 0.001), subj-SE was increased by 8.9 points (n =168, p < 0.001), subj-SD was increased by 16% (baseline: 307.50 ± 88.86 min; post 357.07 ± 91.24 min, subj-SD (n = 174, p < 0.001).

Conclusion

The results of this RWS suggest this insomnia program has a high engagement compared to other digital CBT-I programs and is as effective as traditional in-person CBT-I. This new generation of Insomnia therapy combining hardware, software and therapist serves as an efficient and engaging treatment implementable at scale.

Support

This study has been supported by Dreem sas.
0548 Overnight Memory Consolidation in Insomnia versus Normal and Experimentally Disrupted Sleep
Authors: Omlin X , Reid M J , Sharman R , Schneider J , Espie C A , Kyle S D
Published: May 2020

Introduction

Healthy sleep is assumed to play an important role in the consolidation of newly acquired memories. Evidence suggest that periods of sleep after learning facilitates memory consolidation relative to wakefulness. Insomnia is associated with cognitive impairment but few studies have assessed overnight memory consolidation. We compared overnight consolidation in people with insomnia to a group of good sleepers who were randomised to either a normal night of sleep (uninterrupted sleep, US) or one night of sleep continuity disruption via forced awakenings (FA).

Methods

51 good sleepers (37 female; mean age: 24 years, SD: 3.63), randomised to either one night of US (n=24) or one night of FA (n=27), were compared to 27 participants meeting criteria for insomnia disorder (23 female; mean age: 53 years, SD: 8.34) who were assessed at baseline as part of a randomised controlled trial of digital cognitive-behavioural therapy. Overnight memory consolidation (difference in correctly recalled word pairs between evening and morning recall) was assessed using the same word-pair task and protocol in the two lab-based studies.

Results

Overnight memory consolidation was significantly lower in the insomnia (mean: 5.4, SD: 5.8, p=0.001) and the FA (mean: 6.7, SD: 4.1, p<0.001) group compared to the US group (mean: 11.6, SD: 5.3). However, when adjusted for age only the FA group, but not the insomnia group, showed significantly lower memory performance than the US group.

Conclusion

While our findings suggest that overnight memory consolidation is impaired in insomnia relative to normal sleep we cannot rule out an age-related explanation given the difference in ages between the study samples. Future work will assess whether overnight consolidation improves following cognitive behavioural therapy.

Support

The research was supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) and the Dr Mortimer and Theresa Sackler Foundation. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
0554 Insomnia Disorder Predicts Stressful Life Events in Individuals Who Have Recently Experienced Involuntary Job Loss
Authors: Skobic I , Howe G , Haynes P L
Published: May 2020

Introduction

The stress generation hypothesis posits that depressed (versus non-depressed) individuals generate more stressful life events, especially events for which they are at least partly responsible (i.e., dependent events). Insomnia disorder interferes with emotion regulation, potentially leading to impaired decision-making and increased stress generation. We hypothesized that insomnia disorder would lead to an increased number of stressful life events in our sample of adults who have recently experienced involuntary job loss.

Methods

Assessing Daily Activity Patterns through Occupational Transitions is a longitudinal study examining linkages between job-loss, sleep, obesity, and mental health. We used baseline and 3-month follow-up data from 137 participants who completed the Life Events and Difficulties Schedule, a contextual life event measure. Insomnia disorder was coded yes if participants met ICSD-3 criteria for a current chronic or acute insomnia disorder on the Duke Structured Interview for Sleep Disorders. Covariates included age, gender, and race. Linear and logistic regression were employed to assess changes in number of events over time. Secondary analysis examined the relationship between insomnia and dependent stressful life events specifically.

Results

When controlling for covariates, insomnia disorder at study baseline predicted the number of stressful life events generated between baseline and 3-month follow-up (β =.60, se=.30, t=1.99, p=.05). Conversely, events at baseline did not predict insomnia disorder at follow-up when controlling for baseline insomnia disorder (OR=.98, CI=.82-1.17). Secondary analysis revealed a trend toward increased generation of dependent events among individuals with insomnia disorder (β =.37, se=.23, t = 1.6, p=.11).

Conclusion

Our analyses provide preliminary evidence for a causal relationship between insomnia disorder and stress generation. Additional research is needed to replicate and examine the mechanisms behind this relationship. This extension of the stress generation hypothesis may have important implications for harm reduction interventions for insomnia disorder.

Support

#1R01HL117995-01A1.
0560 The Effect of Smoking on OSA Endotypes: A Retrospective Cohort Study
Authors: Al-Azzawi S , Orr J E , DeYoung P , Owens R L , Malhotra A , Schmickl C N
Published: May 2020

Introduction

Smoking is a purported risk factor for obstructive sleep apnea (OSA), but the mechanisms through which smoking may cause OSA are largely unclear. Our goal is to assess the effect of smoking on the pathophysiological traits (“endotypes”) underlying OSA.

Methods

Based on a chart review we are creating a retrospective cohort of consecutive patients who were newly diagnosed with OSA based on an inlab polysomnogram between 1/2016 and 6/2018 and who have a documented smoking status. For each subject we are quantifying the endotypes (e.g. arousal threshold, loop gain, upper airway muscle recruitment) via a validated polysomnography-based algorithm. Additionally, we are estimating the arousal threshold based on a clinical prediction score. We are comparing OSA endotypes (primary outcomes), sleep apnea severity (apnea-hypopnea index, SpO2 nadir) and sleep parameters (e.g. total sleep time, sleep efficiency, sleep stages) in current vs former vs never smokers using Kruskal-Wallis tests (+Dunn’s test for post hoc comparisons).

Results

To date we have screened 334 of 2,138 subjects and identified 99 eligible subjects (5 current smokers at the time of polysomnography, 37 former smokers, and 57 never smokers). The clinical arousal threshold was similar across groups (P=.69); polysomnography-based endotype measures are pending. Further, there was no significant difference in sleep apnea severity or sleep parameters across groups, except stage N2 which was less in current vs former smokers (median-percentage 48.5 vs 66.3%, P<.05) and less in never vs former smokers (61.6 vs 66.3%, P<.05).

Conclusion

Overall, former vs never smokers appear to be similar with regards to sleep and sleep apnea parameters. Prevalence of current smokers appears to be low (5%) in our cohort; larger sample size and polysomnography-based endotypes are needed before firm conclusions about the effects of smoking on OSA mechanisms can be reached (data collection continues).

Support

This study had no specific funding. Christopher Schmickl is supported by NIH T32 grant HL134632.
0563 Inspiratory Flow Limitation in Non OSA Individuals: Risk Factors and Clinical Complaints After 8 Years of Follow in a General Population
Authors: Palombini L , de Godoy L B , Andersen M L , Poyares D , Tufik S
Published: May 2020

Introduction

Inspiratory flow limitation (IFL) indicated by the flattening of inspiratory curve, is a respiratory pattern in polysomnography (PSG) suggested as a parameter used to identify individuals with sleep breathing disorder. The cutoff value is still not well defined. The purpose of this study was to evaluate the frequency and clinical impact of IFL after 8-year follow up ingeneral population.

Methods

MethodsBaseline sample was derived from a prospective population-based study (Epidemiologic Sleep Study, EPISONO). A total of 1,042 subjects completed the study assessments in 2007 and 712 from these participants were reassessed in 2016.Full night PSG at baseline and follow-up was performed and clinical outcomes were analyzed. IFL was manually scored and TST spent in IFL during sleep was calculated.

Results

In 2007 and 2016, IFL in non OSA individuals′ mean value was 10.1% and 17.7 % of TST and 95th percentile was 37.8 % and 49.9 % respectively. OSA patients had higher BMI than nonOSA in 2007 (p = 0.01), however, BMI and age were not risk factors to develop OSA or to increase IFL after 8 years. Individuals with IFL that became OSA after 8 years had a higher BMI, regardless of time, than those that did not develop OSA. Individuals who presented <15% of TST with IFL in 2007 and changed to ≥15% in 2016demonstrated significantly worse Beck depression score compared to group that maintained IFL < 5%. Individuals with ≥ 15% of TST with IFL in 2007 and in 2016 also increased depression severity score and Whoqol social relationship and environment domainscompared to the group with <15%.

Conclusion

Non OSA individuals presented 10.1% in 2007 and 17.7% in 2016 of TST in IFL. After 8 years, individuals with ≥15% of IFL presented worsening of depression severity and sleep quality.

Support

The authors would like to thank for the support by grants from Associação Fundo de Incentivo a Pesquisa (AFIP), Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES).