bluuebunny/crossref_metadata_2025 huggingface dataset:
0358 Prevalence of Insomnia Symptoms and Insomnia Disorder within VA Subacute Rehabilitation
Authors: Boeve Angelica , Boyle Julia , Moye Jennifer , Driver Jane , Ruopp Marcus , O'Malley Kelly
Published: May 2023

Introduction

Approximately 40% of Veterans report insomnia symptoms and 12% of Veterans have a formal insomnia disorder diagnosis. While these numbers reflect outpatient prevalence rates, there is little data on the prevalence of insomnia symptoms and insomnia disorder among the 32,000 Veterans receiving care within VA Community Living Centers (CLC) (rehabilitation and long-term care facilities) each year. The present analysis provides an initial step in understanding the prevalence of insomnia disorder vs. insomnia symptoms within a local VA CLC subacute rehabilitation unit. This analysis is part of a clinical innovation project that evaluated Veterans’ sleep during admission for the purposes of informing clinical interventions.

Methods

67 Veterans were admitted to a VA subacute rehabilitation unit following hospital discharge between March and August 2022. Veterans were asked to complete a brief evaluation within 7 days of admission, including the Insomnia Severity Index (ISI), Sleep Need Questionnaire (SNQ), and Epworth Sleepiness Scale (ESS). Sleep disorder diagnoses were obtained through chart reviews. Descriptive statistics were used to evaluate the prevalence of sleep disorders, insomnia severity, sleep need, and daytime sleepiness.

Results

48 of 67 (71.6%) Veterans (Mage=72.8±12.0;97.9%male;79.2%white) completed evaluations within 7 days of admission. 52.1% of Veterans reported at least subthreshold insomnia (ISI≥8) with 22.9% reporting moderately severe clinical insomnia (ISI≥15). 50% reported not meeting their sleep need (SNQ≥13) and 33.3% reported at least mild levels of daytime sleepiness (ESS≥11). Chart reviews indicated only 25% of Veterans had a formal sleep disorder diagnosis in their chart and only 4.2% Veterans had a formal diagnosis of insomnia disorder.

Conclusion

The results of this preliminary analysis highlighted the discrepancy between national outpatient statistics and local inpatient statistics on the prevalence of insomnia symptoms and disorder. While the Veterans admitted to the CLC may be experiencing additional factors influencing their sleep (e.g., environmental disruptors), this does not wholly explain the discrepancy between the local and national ­samples. Future evaluations should include multiple VA sites to obtain a more representative sample of Veterans. Clinically, these findings suggest that insomnia disorder should be considered a standalone diagnosis and added to Veterans’ charts when clinically elevated symptomology is endorsed.

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0359 Relationships Between Sleep Valuation and Sleep Patterns
Authors: Lundy Bethany , Nielson Spencer , Kay Daniel
Published: May 2023

Introduction

Sleep valuation is the relative worth placed on sleep. Individual differences in sleep valuation relate to age, gender, depression, and overall sleep health. The factor structure of sleep valuation and how subfactors of sleep valuation relate to sleep health outcomes remain unclear. This study investigated how latent factors of sleep valuation relate to sleep health.

Methods

Data were collected from 125 adults, primarily college students (59% female, mean age 21, and 87% white), who completed the 43-item Sleep Valuation Item Bank, the Insomnia Severity Index, and a standard sleep diary. Based on observations from a previous study, sleep valuation items were separated from sleep devaluation items and principal axis factoring analyses were run for each set of items. Spearman’s correlation analyses were used to explore associations between sleep valuation and devaluation subfactors with demographics, general and mental health, insomnia severity, in bed time, total sleep time, and sleep efficiency reported on the sleep diary for the prior night.

Results

Based on the scree plot method, three sleep valuation (sleep wanting, preference/prioritizing, and enjoyment) and two devaluation (sleep aversion and procrastination) subfactors emerged in the factor analysis. Greater sleep wanting was associated with female gender, poorer general and mental health, more severe insomnia, and later bedtime, p<.05, for all. Sleep preference/prioritizing was associated with female gender and poorer mental health, p<.05, for all. Sleep enjoyment was associated with lower insomnia severity and greater sleep efficiency, p<.05, for all. Sleep aversion was not associated with any sleep diary variable. Sleep procrastination was associated with a later bedtime, less time in bed, and greater insomnia severity, p<.05, for all.

Conclusion

Findings closely replicated prior studies including a similar factor structure and the association of sleep valuation to gender, mental and physical health, and insomnia severity. Sleep valuation and devaluation patterns were intimately related to self-reported sleep behaviors. The direction of these associations could not be determined. Nevertheless, we recommend development and testing of primary and tertiary interventions that target sleep valuation patterns to explore their impact on sleep health behaviors.

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n/a
0360 Shifts in Daytime Functioning Items on the Insomnia Severity Scale with Lemborexant after 6 Months of Treatment
Authors: Chepke Craig , Cote Kimberly , Pinner Kate , Yardley Jane , Moline Margaret
Published: May 2023

Introduction

The Insomnia Severity Index (ISI) is a 7-item self-reported questionnaire evaluating perception of symptom severity included in Phase 3 studies of lemborexant (LEM), a competitive dual orexin receptor antagonist approved in several countries to treat adults with insomnia. The ISI total score, and items 4-7 for daytime function (DF), improved significantly with LEM treatment compared to placebo (PBO) as assessed at 1, 3 and 6 months. Here we report shifts in DF scores at 6 months depending on baseline severity.

Methods

Study 303 was a 12-month, randomized, double-blind PBO-controlled (first 6months; Treatment Period 1 [TP1]) phase 3 study in subjects (age ≥18y) with insomnia disorder. Subjects were randomized to PBO, LEM 5mg (LEM5) or 10mg (LEM10) for 6 months. ISI items are rated on a 5-point Likert scale from 0 (no problem) to 4 (very severe problem). Daytime-related items include ratings on sleep satisfaction, extent symptoms are noticeable to others, cause worry/distress, or interferes with daily function. Data were analyzed by Cochran-Mantel-Haenszel test of general association vs placebo.

Results

Of the 949 subjects, 749 (78.9%) completed the ISI at baseline and end of TP1: PBO (258/318 [81.1%]; LEM5, 257/316 [81.3%]; LEM10, 234/315 [74.3%]). Baseline daytime ISI-total-score distribution was similar between groups; most had scores of 9-12 (66.7-68.6%). At the end of TP1, more subjects with baseline scores of 9-12 shifted to 0-4 with LEM5 (49.7%) and LEM10 (46.2%) than with PBO (26.6%). Similarly, more subjects with baseline scores of 13-16 shifted to 0-4 with LEM5 (39.1%) and LEM10 (46.3%) than with PBO (29.6%). An additional 28.1% and 25.9% of subjects with LEM5 or LEM10, respectively, with baseline scores of 13-16 shifted to scores of 9-12, compared with 31.5% of PBO. The overall shift distributions were significantly different, favoring both LEM groups (p< 0.01).

Conclusion

More LEM-treated subjects improved in daytime functioning as evidenced by the significantly large number of subjects whose scores moved into the lower categories (i.e., better sleep) compared with PBO subjects. These data support important improvements in daytime function that are evident even after 6 months of continuous LEM treatment.

Support (if any)

Eisai Inc.
0364 The Effect of Lemborexant on Polysomnographic Sleep Parameters in Adults with Mild, Moderate, or Severe Obstructive Sleep Apnea
Authors: Moline Margaret , Cheng Jocelyn , Hall Nancy , Shah Dhara , Zammit Gary
Published: May 2023

Introduction

Several commonly prescribed hypnotics may worsen respiratory function, especially in the elderly. Lemborexant (LEM) is a dual-orexin-receptor-antagonist approved to treat adults with insomnia. In Studies 102 (NCT03471871) and 113 (NCT04647383), LEM demonstrated respiratory safety in subjects with mild, moderate, or severe obstructive sleep apnea (OSA) who did not report insomnia. The current analyses evaluated sleep variables from these studies.

Methods

Studies 102 and 113 were double-blind, placebo (PBO)-controlled, crossover studies in adults with untreated mild (apnea-hypopnea-index [AHI] ≥5 to < 15), moderate (AHI≥15 to < 30), or severe (AHI≥30) OSA, without insomnia. Subjects were randomized to two 8-night periods (separated by ≥14 days) treated with LEM 10mg (LEM10) or PBO. Latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were assessed using polysomnography on Days 1 (D1) and 8 (D8).

Results

The analysis set comprised 39, 13, and 20 subjects with mild, moderate, or severe OSA, respectively. On both days, LPS was not statistically different from PBO in any group. Compared with PBO, SE was significantly greater on D1 in subjects with mild (LEM10, 90.43; PBO, 80.31; P< 0.0001), moderate (LEM10, 88.83; PBO, 84.02; P=0.016), and severe (LEM10, 87.76; PBO, 77.84; P< 0.0001) OSA. On D8, SE was significantly greater in subjects with mild (LEM10, 86.65; PBO, 80.59; P=0.003) and moderate (LEM10, 88.45; PBO, 80.70; P=0.004) OSA, with a trend towards significance in subjects with severe (LEM10, 85.60; PBO, 80.63; P=0.055) OSA. WASO was significantly lower (improved) on D1 in subjects with mild (LEM10, 33.30; PBO, 76.76; P< 0.0001), moderate (LEM10, 44.26; PBO, 64.71; P=0.008), and severe (LEM10, 42.03; PBO, 91.49; P< 0.0001) OSA. On D8, WASO was significantly lower in subjects with mild (LEM10, 51.74; PBO, 70.52; P=0.015) and moderate (LEM10, 49.16; PBO, 75.15; P=0.008) but not severe (LEM10, 59.85; PBO, 74.46; P=0.161) OSA. LEM was well-tolerated.

Conclusion

In untreated OSA subjects without insomnia, irrespective of OSA severity, LEM improved sleep maintenance versus PBO. LPS did not differ between treatments since such patients may not report sleep onset difficulties. These findings support the use of LEM for patients with comorbid insomnia and sleep apnea (COMISA).

Support (if any)

Eisai, Inc.
0367 Urban Stress and Sleep Health by Proximal Neighborhood Groups in Washington, DC
Authors: Jackson Alexus , Ize-Iyamu Osayi , DeLeon Rodrigo , Poindexter Milan , Mellman Thomas
Published: May 2023

Introduction

African Americans are disproportionately affected by environmental factors that increase the risk for negative health outcomes. Analyses from National Health Interview Survey (NHIS) data estimated 15 to 75 percent of the disparities between Black and White respondents being accounted for by residential context. Poor sleep health, particularly short sleep duration, has been linked to metabolic and cardiovascular disease. A population study indicated that sleep duration of less than 6 hours was more common among African Americans compared with other racial groups in the United States and this association was accounted for by African Americans living in high density urban environments. Threats of violence may engender feelings of vulnerability when sleeping and be an important determinant of sleep health though this relationship has not been adequately studied. The aim of this study is to determine how an individual’s sleep health relates to violent crime rates in their neighborhood of residence as well as indicators of neighborhood stress endorsed in a self-reported survey.

Methods

African- American men and women between the ages of 18-35 filled out the insomnia severity index (ISI) and city stress inventory (CSI). Sleep duration and sleep efficiency were obtained through home-based actigraphy. Participants were categorized as poor sleepers if two out of three criteria were met: sleep duration of less than six hours, ISI greater than 10, and sleep efficiency below 85%. Participants addresses were linked to one of the 51 proximal neighborhood groups (PNG) defined by the DC Department of Health and Office of Planning using MAR geocoder and QGIS mapping software. Violent death rates and other social health determinants are indicated by PNG in the DC DOH’s Health Equity Report (2019).

Results

Sleep measures were not correlated with neighborhood violent death rates (Pearson r’s: .05 - .17; all NS). SE and TST were weakly correlated with CSI scores (both r’s = -.22, NS).

Conclusion

The negative findings may be related to sample size, the presence of threat and crime in all of the locations, and the importance of individual coping.

Support (if any)

NIHLB grant R01HL136626 to Dr. Thomas A. Mellman and NCATS grant for a Clinical Translational Science Award UL1-TR001409.
0370 A three-arm randomized controlled trial examining mindfulness-based and cognitive-behavioral therapies for prenatal insomnia
Authors: Kalmbach David , Cheng Philip , Ong Jason , Reffi Anthony , Fellman-Couture Cynthia , Seymour Grace , Bayoneto Alec , Roth Thomas , Drake Christopher
Published: May 2023

Introduction

Cognitive behavioral therapy for insomnia (CBTI) improves sleep in pregnancy, but its therapeutic benefits may be diminished in pregnancy due to undertreatment of cognitive arousal (i.e., heightened cognitive activity, especially at night). A recent proof-of-concept, single-arm trial suggested that combining behavioral sleep strategies with mindfulness components produced large reductions in prenatal insomnia, depression, and cognitive arousal. The present study was a randomized controlled trial evaluating the effectiveness of this mindfulness-based intervention and CBTI relative to a control condition.

Methods

Sixty-four pregnant women with clinically significant insomnia symptoms were randomized to a mindfulness-based intervention, CBTI, or control. The mindfulness intervention was Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness framework and tailors all components to pregnancy. PUMAS and CBTI were delivered via six telemedicine sessions, whereas control patients electronically received six weekly information sheets on perinatal sleep health. Treatment outcomes were assessed before and after treatment, which included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), and pre-sleep arousal scale’s cognitive factor (PSASC; nocturnal cognitive arousal). Treatment outcomes were analyzed via general linear models, and the PRODCLIN method tested mediation models in evaluation of treatment mechanisms.

Results

Intent-to-treat analyses revealed significant ISI reductions in the PUMAS (-11.05±3.84) and CBTI (-11.20±6.87) conditions relative to control (-4.27±1.96). Insomnia remission rates were highest among PUMAS patients (81.8%), whereas 65.0% of CBTI patients and 13.6% of controls remitted. PUMAS significantly alleviated depression relative to control (EPDS: -3.77±3.88 vs -0.59±2.84, p=.017), whereas CBTI did not differ from either group (EPDS: -2.55±4.25, p-values ≥ .271). Similarly, PUMAS alleviated cognitive arousal relative to control (PSASC: -8.82±4.99 vs -3.45±4.53, p=.009), whereas CBTI did not differ from either group (PSASC: -7.30±7.49, p-values ≥ .104). Mediation analyses estimated that reductions in cognitive arousal mediated 26.6% and 40.6% of PUMAS effects on insomnia and depression.

Conclusion

PUMAS alleviated insomnia, depression, and cognitive arousal relative to control. Reducing cognitive arousal was a significant treatment mechanism by which PUMAS alleviated insomnia and depression. By comparison, CBTI significantly alleviated insomnia relative to control, but yielded no significant effects on depression or cognitive arousal.

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0371 Acute effects of cannabinoids in insomnia disorder: a randomised, placebo-controlled trial using high-density EEG
Authors: Suraev Anastasia , McGregor Iain , Marshall Nathaniel , Kao Tancy , D'Rozario Angela , Grunstein Ron , Hoyos Camilla
Published: May 2023

Introduction

Medicinal cannabis is often cited as a popular alternative to common sleep aids; however, there are limited studies using complex sleep EEG methods examining its’ effects in insomnia disorder.

Methods

Twenty participants (16 female; mean [SD] age, 47.1 [8.7] years) with insomnia disorder (mean ISI=20.8) completed two 24-hour in-laboratory visits during which they received a single oral dose of ‘CBD/THC’ containing 200 mg cannabidiol (CBD) and 10 mg Δ9-tetrahydrocannabinol (THC) or matched placebo. Co-primary outcomes were total sleep time (TST) and wake after sleep onset (WASO). Secondary outcomes included next-day neurobehavioural function and sleep architecture metrics determined using overnight polysomnography with high-density EEG. Trial registration: ACTRN12619000714189.

Results

Compared to placebo, CBD/THC significantly decreased TST (-24.5 min, p=0.047) with no significant change to WASO (+10.7 min, p=0.422). CBD/THC significantly decreased time spent in REM sleep (-8.1%, p< 0.001) and increased REM sleep latency (+65.6 min, p=0.008). High-density EEG analysis revealed a significant reduction in high-frequency EEG activity overlying the posterior and frontal cortex during N2 sleep with CBD/THC treatment compared to placebo. CBD/THC treatment also reduced delta activity in the posterior region of the brain during N3 sleep and increased alpha and beta activity during REM sleep in the posterior regions of the brain relative to placebo (all p’s< 0.05). CBD/THC did not impair next-day (+12 h post-treatment) cognitive performance, alertness, or simulated driving performance (all p’s>0.05). Eighty-five mild, non-serious, adverse events were reported (55 during ETC120; most common dry mouth, drowsiness, and fatigue).

Conclusion

An acute dose of combined 200 mg CBD and 10 mg THC reduced TST with a clear effect of REM sleep suppression. However, no next-day residual impairment on cognitive function, alertness or simulated driving performance were observed. Further research is required to determine the impact of chronic cannabinoid dosing on REM sleep and other objective sleep outcomes in insomnia disorder.

Support (if any)

The study was funded by the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded centre for cannabinoid research at the University of Sydney, Australia.
0372 Association between the real-world use of GABA receptor agonists and daytime impairment in US patients with insomnia
Authors: Büsser Alexander , Olivieri Antonio , Ahuja Ajay , McCall William V , Grandner Michael
Published: May 2023

Introduction

Currently available data inadequately quantify daytime impairment associated with insomnia disorder and the impact of its treatments in the real-world setting. The objective of this real-world study was to retrospectively examine daytime impairment symptoms before and during pharmacological treatment with non-benzodiazepine receptor agonists (non-BzRAs) and benzodiazepines in US patients with insomnia.

Methods

Information from HealthVerity was retrieved for patients with insomnia aged ≥ 18 years prescribed non-BzRAs or benzodiazepines as first-line treatment between October 2015 and March 2020. For each patient with data, insurance claims data were extracted alongside physician notes in free-text form. Patient demographics and prescription information were extracted from the claims. Daytime impairment symptoms were extracted and quantified from physician notes using an ontology designed with three domains (i.e., alert/cognition, mood and sleepiness) and 14 items analogous to the Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ). This ontology extends IDSIQ terms to 109 terms in total to reflect the language of physicians. The annualized rate of daytime impairment measures the frequency of symptoms occurring from 182 days before treatment start to about three months (mean) during treatment. The rate is normalized by one year as the duration before and during treatment is different. A single symptom of a visit is counted maximally once within a specific domain.

Results

2361 and 1045 unique patients were prescribed non-BzRAs and benzodiazepines, respectively. Non-BzRAs treatment was associated with a statistically significant 16% overall increase of daytime impairment symptoms during versus before treatment (p=0.003). Statistically significant increase of daytime impairment symptoms with non-BzRA treatment was observed in the alert/cognitive (16%,p=0.019), mood (22%,p=0.002) domains, but only nominal increase in the sleepiness domain (12%,p=0.084). Benzodiazepine treatment was associated with a statistically significant 19% overall increase of daytime impairment symptoms during versus before treatment (p=0.047), with a statistically significant increase seen in the mood domain (26%,p=0.030) but only nominal increases in the alert/cognitive (7%,p=0.76), and sleepiness (21%,p=0.079) domains.

Conclusion

This study shows that treatment of insomnia with commonly used drugs (i.e. non-BzRA and benzodiazepines) is associated with an overall increase in daytime impairment symptoms in a real-world setting.

Support (if any)

Idorsia Pharmaceuticals Ltd.
0373 Association of U.S. Military Burn Pit Smoke Exposure with Insomnia and Sleep Apnea Symptoms
Authors: Nowakowski Sara , Razjouyan Javad , Kokonda Manasa , Christie Israel , Helmer Drew
Published: May 2023

Introduction

Burn pits (BPs) have been widely used by the U.S. military for waste disposal. Due to the obviously toxic nature of the BP emissions, exposure may contribute to diverse adverse health conditions, including sleep apnea. To our knowledge, this is the first study to examine the association between self-estimated amount of BP emission exposure and self-reported sleep complaints.

Methods

We used an online health questionnaire of the VA/DoD Airborne Hazards and Open Burn Pit Registry administered between April 2014 and August 2022 to 320,231 Veterans and active-duty personnel (age 40.1±9.2 years, BMI 28.8±4.5 kg/m2, 11% female, 75% white). Outcomes included insomnia, short sleep duration < 6hrs, sleep apnea events, and snoring. The exposure variable was cumulative BP exposure that was calculated by multiplying the response (in hours) to a question about burn pit exposure by number of deployment days, summing across deployments, and categorizing by quartile. We employed separate logistic regression models to determine the association between cumulative BP exposure days and sleep outcomes using no BP exposure as the reference. We adjusted the models by age, BMI, sex, race, ethnicity, military branch and duty status.

Results

We observed higher odds of insomnia as the duration of BP exposure increased in each quartile (Q1-Q4 ORs:1.8-3.4, p<.001). The same trend was observed for shorter sleep duration (Q1-Q4 ORs:1.6-2.4, p<.001), sleep apnea (Q1-Q4 ORs:1.4-2.4, p<.0001) and snoring (Q1-Q4 ORs:1.3-1.8, p<.0001).

Conclusion

Higher levels of BP emission exposure was associated with a greater report of insomnia symptoms, shorter sleep duration, snoring and sleep apnea events. Future research will focus on examining the association of BP emission ­exposure and objective sleep data extracted from polysomnography reports in the Veteran Affairs electronic medical records.

Support (if any)

This work is supported by the Department of Veteran Affairs, Veterans Health Administration, Office of Research and Development, and the Center for Innovations in Quality, Effectiveness and Safety (CIN 13-413), Michael E DeBakey Veteran Affairs Medical Center Bridge Grant (PI: Nowakowski), and the VA Airborne Hazards and Burn Pit Center of Excellence Pilot Grant (PI: Nowakowski).
0374 Does adding a chatbot and human support enhance treatment adherence to and efficacy of digital CBTi? A randomized controlled trial
Authors: Chan Wai Sze , Cheng Wing Yee , Lok Samson H C , Cheah Amanda K M , Lee Anna K W
Published: May 2023

Introduction

Digital cognitive behavioral therapy for insomnia (dCBTi) has been shown to be efficacious; however, treatment adherence and efficacy are suboptimal compared to CBTi delivered in person. The present study evaluated whether the addition of different types of coaching support (i.e., phone coaching by a therapist trained in CBTi, phone coaching by a research assistant not trained in CBTi, and virtual coaching by a chatbot that simulates human dialogue) would improve treatment adherence to and efficacy of dCBTi. It was hypothesized that the addition of any form of coaching will have beneficial effects, with therapist coaching achieving the best outcomes.

Methods

A single-blind, parallel, randomized controlled trial was conducted. One-hundred-fifty adults with insomnia, indicated by Insomnia Severity Index (ISI) >=10, were randomly assigned to one of the five conditions: dCBTi with three 20-min therapist phone coaching sessions (C1), dCBTi with three 20-min non-therapist phone coaching sessions (C2), dCBTi with chatbot virtual coaching (C3), dCBTi without any coaching (C4), and the sleep hygiene and sleep diary control (C5). dCBTi is a smartphone application adopting a six-session CBTi with components of sleep hygiene, sleep restriction, stimulus control, relaxation, and cognitive therapy. Participants completed sleep diaries, ISI, dysfunctional beliefs about sleep (DBAS), sleep-related behavior questionnaire (SRBQ), and measures of mood, fatigue, and quality of life at pre-intervention, post-intervention, and 4-week follow-up.

Results

Mixed modeling analysis showed that participants in C1, C2, C3, and C4 had greater improvements in insomnia symptoms, sleep efficiency, DBAS, SRBQ, mood, and fatigue than C5. Participants in C1 had significantly greater treatment adherence and improvement in DBAS and SRBQ than those in C4; those in conditions with any form of coaching had greater treatment adherence than those in C4. However, improvements in insomnia symptoms were not significantly different between conditions with or without coaching.

Conclusion

Adding human support, especially therapist phone coaching, improved treatment adherence to dCBTi but not efficacy. Nonetheless, adding therapist coaching led to greater improvements in the mechanisms of change, i.e., reductions in dysfunctional beliefs and behaviors related to insomnia, which may promote greater maintenance of treatment efficacy at longer follow-up. Clinicaltrials.gov registration#: NCT05136638

Support (if any)

HKU Fund for Translation Research #104005654
0375 Increased Engagement with a Tailored Sleep Guide is Associated with Reduced Variability in Sleep Efficiency in Chronic Insomnia
Authors: Fanson Freya , Hansen Devon , Gottlieb Elie , Raymann Roy , Danoff-Burg Sharon , Buchwald Dedra , Van Dongen Hans , Watson Nathaniel
Published: May 2023

Introduction

Insomnia is highly prevalent, but difficult to diagnose due to night-to-night sleep variability, and difficult to treat in part due to the lack of trained providers. Consumer sleep technology (CST) allows for longitudinal sleep monitoring in a natural environment. One such device, the Sleep Score Max (SleepScore Labs) combines longitudinal non-contact sleep tracking via radio-frequency biomotion sensor technology with an individualized sleep guide function, which provides tailored recommendations to improve sleep based on the user’s objectively measured sleep, bedroom environment, and self-reported daily activity. Focusing on sleep efficiency, we examined if level of engagement with the sleep guide is related to sleep improvement in chronic insomnia.

Methods

As part of a larger study, N=30 individuals with chronic insomnia (ages 38.7±14.9; 8 male) participated in an 8-week at-home sleep monitoring study. Enrollment criteria included being 18-65y old and meeting ICSD-3 criteria for chronic insomnia with no other clinically relevant condition contributing to sleep disturbance. Participants were instructed to track their sleep with the aforementioned device and engage with the sleep guide daily for 8 consecutive weeks. For observed sleep efficiency, means (characterizing sleep overall) and within-subject standard deviations (characterizing ­night-to-night variability) were assessed by week, and change scores from week 1 to week 8 were correlated with level of engagement with the sleep guide function (defined as percentage of days interacted with the guide within the 8-week period).

Results

From week 1 to week 8, mean sleep efficiency increased non-significantly (t[23]=0.83, p=0.42), but night-to-night variability decreased significantly (t[23]=-2.16, p=0.041). There was no significant relationship between change in mean sleep efficiency and level of engagement with the sleep guide (r=0.005, p=0.980), but there was a significant relationship between change in night-to-night variability and level of engagement (r=-0.48, p=0.018), such that night-to-night ­variability decreased more in those with greater engagement.

Conclusion

Night-to-night sleep variability is a chief complaint of people with chronic insomnia, and reduced night-to-night variability in sleep efficiency may indicate improvement. As such, engagement with an individualized sleep guide incorporated in a CST device may help individuals with chronic insomnia improve their sleep.

Support (if any)

NIH grant KL2TR002317; research devices provided by SleepScore Labs.
0376 Long-Term Effectiveness of Cognitive-Behavioral Therapy for Insomnia: A Patient-Reported Outcomes Post-Treatment Study
Authors: Lenker Kristina , Bourchtein Elizaveta , Paquet Caitlin , Calhoun Susan , Fernandez-Mendoza Julio
Published: May 2023

Introduction

Insomnia is the most prevalent sleep disorder, with 10% of adults meeting criteria for a chronic insomnia disorder (CID). Cognitive-behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment given the strong evidence supporting its efficacy in the short-term and mid-term. Less is known about the effectiveness of CBT-I in routine clinical practice on patient-reported outcomes beyond 3y post-treatment.

Methods

Participants included 68 adults (48±15 years old, 63% female, and 11% minority) who received CBT-I for CID at the Behavioral Sleep Medicine (BSM) program of Penn State Health Sleep Research & Treatment Center3 to 7y prior to the present study. Participants completed Insomnia Severity Index (ISI) and Flinders Fatigue Scale (FFS) at baseline and follow up.

Results

After a median of 5y follow-up, 50% of patients didn’t meet insomnia case definition (ISI< 11), and 60% had experienced a meaningful improvement in insomnia severity (change in ISI score of -6 points or more). Only 35% of patients continued to experience moderate-to-severe insomnia (ISI>14) at follow-up. These effects were similar in patients who had a history of a medical (n=42) or psychiatric (n=38) disorder at pre-treatment when compared to those without prior medical or psychiatric disorders (p=0.380 and p=0.467 for insomnia caseness, respectively). The percent of patients absent of clinically significant daytime fatigue (FFS< 13) increased from 29% to 50 after the same period of long-term follow-up, and those with moderate-to-severe daytime fatigue (FFS>15) fell from 62% to 38%. Hypnotic use (i.e., prescription or over-the-counter) decreased from 66% at baseline, though this varied by insomnia status at follow-up: while 56% of insomnia cases (n=34) at follow-up reported still taking medications at bedtime, only 17% of remitted cases (n=34) did (p< 0.001).

Conclusion

This long-term evidence is consistent with prior clinical trials, national trends, and further supports that insomnia is a disorder, not a symptom, comorbid with medical and psychiatric conditions that should be treated independently. The effectiveness outcomes show improved sleep, daytime functioning, and discontinuation of sleep medications, a goal of clinical practice guidelines. Importantly, treatment gains remained after the onset of the COVID-19 pandemic.

Support (if any)

Penn State Health Department of Psychiatry Trainee Award
0384 Assessing the content validity of the IDSIQ through cognitive interviews in individuals with comorbid insomnia and nocturia
Authors: Phillips-Beyer Andrea , Olivieri Antonio , Marco Tobias Di , Kimel Miriam
Published: May 2023

Introduction

The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is validated to measure daytime functioning in individuals with insomnia disorder. This study assessed the content validity of the IDSIQ through cognitive interviews in individuals with insomnia and comorbid nocturia.

Methods

This was a cross-sectional, qualitative observational study. Data were collected from 10 adult subjects from the US suffering from insomnia disorder (DSM-5) and comorbid nocturia (≥2 nocturnal voids). One-on-one, web-based interviews were conducted using semi-structured guides and lasted 60–90 minutes. Based on the stage of the study, all participants examined the content validity of the IDSIQ as part of 1) hybrid concept elicitation and cognitive interviews (n=5; Stage 1), or 2) cognitive interviews (n=5; Stage 2). Institutional review board approval and web-based informed consent were obtained prior to the patient interviews.

Results

The mean age of participants was 59.5 years (SD=4.3) and 62.2 years (SD=8.5) in the hybrid and cognitive interview groups, respectively. All individuals in the hybrid interviews were female, whereas all individuals in the cognitive interviews were male. Participants’ overall impressions were positive (10/10), describing the IDSIQ as straightforward (5/10), good (1/10), simple (1/10), very precise (1/10), very specific (1/10), clear (1/10), and aligned with their experience (3/10). The items were understood by all participants (10/10) except Item 1, which was understood by almost all participants (9/10). One participant suggested that the responses to questions on the IDSIQ may vary depending on the time the survey is administered, and the amount of sleep obtained the previous night. All 10 participants reported that they could answer all questions. Of the nine participants who were asked, all stated that the IDSIQ was relevant to their experience of their condition. Most participants reported that there were no missing items, whereas two participants stated that an item assessing the impact of insomnia on personal relationships (including family) was missing.

Conclusion

The content of the IDSIQ was easy to understand by patients that suffer from insomnia and comorbid nocturia. The study provides evidence for the content validity of the IDSIQ and its applicability in this population.

Support (if any)

Funded by Idorsia Pharmaceuticals Ltd.
0385 Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
Authors: Park Elena , Almanzar Gabriela , Balserak Bilgay , Mula Manasa , Chaudhry Minahil , Mitra Ramyani , Gooneratne Nalaka , Sloane Justin
Published: May 2023

Introduction

Insomnia is a common sleep complaint experienced by 1 in 7 pregnant women (Felder, et al, 2020). In recent years, mindfulness-based interventions have gained popularity among pregnant and postnatal women. We conducted qualitative interviews to explore how pregnant women perceive this type of behavioral intervention and its possible implementation as a smartphone app.

Methods

Participants were identified through OB/GYN physicians at Penn. Research coordinators asked participants questions regarding their perspectives toward a mindfulness-based sleep intervention and experiences related to pregnancy and sleep disturbances. Two study personnel initially identified themes in the responses and assigned each theme to a corresponding numeric value. Then, two other coordinators independently assigned the values to each response. Discrepancies were resolved as a team.

Results

The average age reported amongst the 12 respondents (all pregnant females) was 32 years old (min: 20; max; 39; SD: 4.4). On average, participants were willing to devote about 26 minutes/day to a behavioral intervention for sleep (min: 4; max; 84; SD: 20). Six out of 12 participants reported that stress/worry affects their sleep at least once a month, with two reporting pain and discomfort as also having an impact. All 12 subjects agreed that the use of a behavioral relaxation intervention is an appealing approach to improve sleep. Lastly, 6 out of 12 subjects responded with a willingness to use a behavioral intervention until their expected delivery date with two subjects agreeing to participate but requested stopping several weeks before delivery. All of the patients felt that implementing the mindfulness behavioral intervention as a smartphone app would increase appeal and accessibility.

Conclusion

Current insomnia medication options are limited for pregnant patients. Our data shows potential for the use of behavioral relaxation therapy as an alternative to improving sleep quality among pregnant women by targeting their experiences with stress. Furthermore, results indicate that a follow-up immediately post-delivery may be impractical due to the adjustment period necessary after giving birth. Future clinical studies will explore developing the app and impact on overall insomnia symptom burden in order to explore its utility as a non-pharmacological, easily accessible option for pregnant patients.

Support (if any)
0391 Demographic and clinical characteristics, and insomnia severity symptoms in cancer survivors with insomnia symptoms
Authors: Dean Grace , Kwon Misol , Dickerson Suzanne
Published: May 2023

Introduction

More than 50% of cancer survivors suffer from insomnia symptoms before, during or after cancer treatments, which may eventually progress to an insomnia disorder if not addressed. The current study aims to identify which of the demographic and clinical characteristics relate to subthreshold and clinical insomnia categorized according to Insomnia Severity Index (ISI), among heterogeneous sample of cancer survivors with insomnia symptoms (ISI score >7).

Methods

Baseline data from participants (n=136) from an ongoing trial were used. All participants completed demographic and clinical characteristic assessments (e.g., ISI, Pittsburgh Sleep Quality Index [PSQI], Hospital Anxiety and Depression Scale [HADS], 7-day sleep diary). Descriptive statistics were calculated for demographic and clinical variables. Bivariate comparisons of these variables by insomnia subgroups (subthreshold vs. clinical insomnia) were performed using Fisher's exact test.

Results

The sample included 60 breast, 48 prostate, 19 colorectal, and 7 lung cancer survivors (55.9% female; age=63.8 y, range: 32-82; 87.5% White; BMI=27.9±6.1 kg/m2). The analytical sample (n=134) comprised of 64.7% (n=88) subthreshold and 33.8% (n=46) clinical insomnia subgroups. Those in subthreshold subgroup consisted of more females (n=54, 40.3% vs. n=20, 14.9%), ≥ 65 y (n=51, 38.1% vs. n=22, 16.4%), and >25 BMI (n=55, 41.0% vs. n=35, 26.1%) than those in clinical subgroup. No statistically significant association between previously discussed variables were found. Both subthreshold and clinical insomnia groups had higher number of those with poor sleep quality than good, and sleep efficiency less than 85% than those with ≥85%, by PSQI and sleep diary, respectively. Of the subthreshold subgroup, 87 (64.9%) were identified as having no symptoms of depression, and 80 (59.7%) as having no anxiety, compared to those with symptoms. This was similar for the clinical subgroup where 37 (27.6%) had no symptoms of depression and 27 (20.1%) with no anxiety, compared to those with symptoms. There were statistically significant associations between insomnia subgroups and depression (p<.001) and anxiety (p<.001), respectively.

Conclusion

Preliminary descriptive findings highlight significant characteristics of cancer survivors with subthreshold and clinical insomnia. More clinical symptoms were present among clinical insomnia group. PSQI may identify poor sleepers in cancer survivors.

Support (if any)

NIH/NINR R01NR018215 (Dean), ClinicalTrials-NCT03810365
0401 Factors Associated with Insomnia in Male University Students
Authors: George Brianna , Garland Sheila
Published: May 2023

Introduction

University students can experience high levels of stress, and this can impact sleep quality and increase insomnia symptomology. Little research has investigated insomnia in male university students. This study examined factors associated with insomnia in male students to address concerns and direct resources.

Methods

Male students aged 18-35 at Memorial University completed an online survey. The Insomnia Severity Index (ISI) was used as the dependent variable to measure insomnia. Participants self-reported demographic and academic variables and also completed the Morning Evening Questionnaire (MEQ), Mindful Attention Awareness Scale (MAAS), Medical Outcomes Study Social Support Survey (MOS-SSS), Kessler Psychological Distress Scale (K10), and indicated sleep medication and stimulant use. Univariate and multivariate linear regressions were used to examine the relationship between insomnia and demographic factors, chronotype, social support, mindfulness, psychological distress, and sleep medication and stimulant use.

Results

The majority of participants (n=564; Mage = 23) were white (77.8%), undergraduates (76.3%), and enrolled full-time (90.7%). The mean insomnia severity score was 7.7 (SD = 5.42). Overall, 46% scored in the no insomnia range, 36% scored in the subthreshold insomnia range, 16% scoring in the clinical insomnia (moderate severity) range, and 2% scored in the clinical insomnia (severe) range. At the univariate level, sleep medication use (β = -.275, p < .001), stimulant use (β = -.158, p < .001), chronotype (β = -.344, p < .001), social support (β = -.244, p < .001), mindfulness (β = -.409, p < .001), and distress (β = .577, p < .001), were significantly associated with insomnia symptom severity. In the multivariate model (Adjusted R2 = .40, p < .001), only evening chronotype (β = -.195, p < .001), greater distress (β = .429, p < .001), and sleep medication use (β = -.139, p < .001) remained significantly related to insomnia.

Conclusion

This study identified factors associated with insomnia in male university students. Addressing insomnia, particularly in those with evening chronotype and those who use sleeping medication, may improve psychological distress and the overall well-being of male university students.

Support (if any)

Dr. Sheila Garland is supported by a Canadian Cancer Society Emerging Scholar Award (Survivorship) (grant #707146).
0403 Functional Connectivity of Brain Networks Predicts Polysomnographically Measured Sleep
Authors: Killgore William , Jankowski Samantha , Henderson-Arredondo Kymberly , Hildebrand Lindsey , Elledge Heidi , Lucas Daniel , Dailey Natalie
Published: May 2023

Introduction

The arousal hypothesis predicts that increased cognitive and somatic arousal interfere with sleep among patients with insomnia. Evidence suggests that the connectivity of the brain’s default mode network (DMN) may play an important role in this process. Here, we examined the association between whole cortex resting state functional connectivity and subsequent polysomnographically (PSG) assessed sleep the same night in a sleep laboratory among individuals with documented insomnia.

Methods

We collected data from twenty participants (12 female; age=26.9, SD=6.6 years) meeting criteria for insomnia/sleep disorder. Each participant completed a baseline resting state functional connectivity (rsFC) scan in the early evening and then retired to their own private bedroom in a sleep laboratory. Participants were monitored throughout the night with polysomnography and evaluated for various sleep parameters. Data were analyzed using the CONN Toolbox, v17f. Total Sleep Time from PSG was extracted and entered as a covariate into the whole brain connectivity analysis. Connectivity across the regions identified in the Automated Anatomical Labeling Atlas was assessed using the ROI-to-ROI analysis approach, with a peak signal threshold of p < .001 (uncorrected) and False-Discovery-Rate (FDR) correction seed level correction. We focused on the anterior and posterior medial regions of the DMN.

Results

The analysis showed that TST was significantly negatively correlated with numerous regions throughout the brain (p<.05, FDR corrected), while there were no regions of positive connectivity. Consistent with our hypothesis, we found that greater TST was associated with anticorrelated activation between the anterior cingulate cortex and regions associated with language processing (i.e., Heschl’s gyrus), sensory motor function (precentral and postcentral gyri), superior temporal gyrus, parietal occipital gyrus, temporal pole, and occipital cortex.

Conclusion

Findings suggest that the connectivity of the anterior DMN with language, sensory, motor, and emotional processing regions is related to subsequent PSG measured sleep. Prior work has suggested that stronger anticorrelations between the DMN and task-positive regions is associated with better cognitive performance. Our findings also suggest that stronger anticorrelations between the anterior DMN and these other cortical regions are highly related to sleep among individuals with insomnia.

Support (if any)

W81XWH2010173
0407 Impact of Lemborexant on Daytime Ratings of Sleepiness/Alertness in Subjects with Insomnia Disorder and Baseline Sleepiness
Authors: Ancoli-Israel Sonia , Moline Margaret , Cheng Jocelyn , Kumar Dinesh
Published: May 2023

Introduction

Since the use of sleep-promoting drugs can also lead to residual morning sleepiness, it is important to determine if a new hypnotic is associated with such a carryover effect of treatment. To this end, an assessment of sleepiness/alertness was included in lemborexant (LEM) phase 3 studies. LEM is a competitive dual orexin receptor antagonist approved in several countries for the treatment of adults with insomnia. This post-hoc analysis of Study 304 (E2006-G000-304; NCT02783729) assessed the impact of LEM on morning sleepiness/alertness in subjects who reported at least mild/moderate morning sleepiness at baseline.

Methods

Study 304 was a randomized controlled study in adults ≥55y with insomnia disorder (N=1006). Subjects received bedtime doses of placebo (PBO), LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended release 6.25 mg (not reported here) for 1 month. A daily Sleep Diary assessed morning sleepiness, within 90 min of waketime, with the question “How alert/sleepy do you feel this morning?” rated from 1 (extremely sleepy) to 9 (extremely alert). Scores were averaged over 7-day periods for baseline (single-blind run-in) and first and last 7 days of treatment. Chi-square tests were used to compare the shift from sleepy (≤3) to more alert (>3) between PBO and treatment groups.

Results

At baseline, 59/203 (29.1%), 66/261 (25.3%), and 79/265 (29.8%) of the PBO, LEM5, and LEM10 subjects reported a score ≤3, indicating at least mild/moderate morning sleepiness. At the end of 1 month of treatment, 37/57 (64.9%) of the PBO subjects rated themselves as less sleepy and more alert (>3), compared with 50/64 (78.1%; P=0.11) LEM5- and 58/76 (76.3%; P=0.15) LEM10-treated subjects.

Conclusion

In this study, ~28% of subjects reported morning sleepiness at baseline. More subjects who reported sleepiness at baseline and received LEM reported improved morning alertness during the last week of treatment compared with PBO subjects. These data are concordant with previous findings of a lack of effect of LEM on tasks requiring alertness in the morning.

Support (if any)

Eisai Inc.