bluuebunny/crossref_metadata_2025_split 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

Abstract

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 &lt;0.001), resulting in a slightly poorer Sleep Efficiency (-.016%, p&lt;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&lt;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

Abstract

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

Abstract

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&lt;.001) and PSQI (-2.98 points, p&lt;.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

Abstract

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

Abstract

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

Abstract

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

Abstract

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&lt;.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

Abstract

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&lt; .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 &gt; 1 capsule. Those 4 taking ≥ 10 were younger (p&lt;.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

Abstract

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&lt;0.01, partial η 2=0.13) and a greater increase in interdaily stability (F1,78=12.41, p&lt;0.01, partial η 2=0.25). There was a greater decrease in intradaily variability following PMRT (F1,78=27.96, p&lt;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

Abstract

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&lt;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&lt;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&lt;0.05. Sleep Efficiency (SE) increased by 1.6% (p&lt;0.002) for all, and by 7.1% (p&lt;0.001) for SE&lt;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