bluuebunny/crossref_metadata_2025 huggingface dataset:
0388 Lemborexant Effect on Sleep Parameters in Adults with Moderate or Severe Chronic Obstructive Pulmonary Disease
Authors: Zammit Gary K , Cheng Jocelyn Y , Hall Nancy , Moline Margaret
Published: April 2024

Introduction

Several commonly prescribed hypnotics may worsen respiratory function, especially in the elderly. Lemborexant (LEM) is a competitive dual-orexin-receptor-antagonist approved to treat adults with insomnia. In Study E2006-A001-113 (NCT04647383), LEM demonstrated respiratory safety in participants with untreated moderate-to-severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated sleep variables from this study.

Methods

This double-blind, placebo (PBO)-controlled, crossover study enrolled adults (45–90y) with untreated moderate or severe COPD, assessed by Global Initiative for Obstructive Lung Disease spirometry recommendations (apnea hypopnea index < 15 was allowed). Participants were randomized to LEM 10mg (LEM10) or PBO in two 8-night treatment periods (separated by ≥14d). Latency to persistent sleep (LPS), sleep efficiency, wake after sleep onset (WASO), and total-sleep-time (TST) were assessed using in-laboratory polysomnography on Days 1 (D1) and 8 (D8).

Results

The analysis set comprised 30 adults with moderate (n=25) or severe (n=5) COPD (mean [SD] age, 69.2 [6.3]y; 70.0% female). Six (20%) participants had a medical history of insomnia. Least squares mean (LSM; standard error [SE]) LPS was significantly shorter (improved) with LEM10 compared with PBO on D1 (LEM10, 30.9 [9.0] min; PBO, 51.5 [9.0] min; P< 0.01) and D8 (LEM10, 27.0 [7.0] min; PBO, 46.6 [7.0] min; P< 0.001). LSM (SE) sleep efficiency was significantly higher (improved) with LEM10 compared with PBO on D1 (LEM10, 81.0% [2.6%]; PBO, 66.6% [2.6%]; P< 0.0001) and D8 (LEM10, 77.1% [2.9%]; PBO, 69.4% [2.9%]; P< 0.0001). LSM (SE) WASO was significantly lower (improved) with LEM10 compared with PBO on D1 (LEM10, 68.2 [9.6] min; PBO, 114.6 [9.6] min; P< 0.0001) and D8 (LEM10, 90.4 [9.9] min; PBO, 106.1 [9.9] min; P< 0.0001). LSM (SE) TST was significantly longer (improved) with LEM10 compared with PBO on D1 (LEM10, 388.9 [12.4] min; PBO, 319.5 [12.4] min; P< 0.0001) and D8 (LEM10, 370.1 [13.7] min; PBO, 332.9 [13.7] min; P< 0.0001). LEM was well-tolerated.

Conclusion

In participants with untreated moderate-to-severe COPD, most of whom did not have a medical history of insomnia, LEM improved sleep onset, sleep maintenance, and TST compared with PBO, suggesting LEM may be a potential treatment option for patients with COPD and insomnia.

Support (if any)

Eisai, Inc.
0390 Efficacy of Suvorexant for Insomnia Disorder in Well-controlled Restless Legs Syndrome
Authors: Winkelman John , Zackon Jordana
Published: April 2024

Introduction

Sleep disturbance remains common in patients with a history of Restless Legs Syndrome (RLS), even after RLS symptoms are sufficiently controlled with medication. Multiple potential causes for treatment-refractory sleep disturbance exist, including conditioned insomnia and poor sleep habits due to chronic RLS-related sleep disturbance, and comorbid medical and psychiatric illness. We conducted a placebo-controlled crossover trial to examine the efficacy of suvorexant in improving sleep quality and quantity in patients with well-controlled RLS and persistent insomnia.

Methods

In this double-blind, randomized, placebo-controlled crossover trial, 34 patients with well-controlled RLS were randomized to placebo or suvorexant (10-20 mg) for 6 weeks, followed by a 2-week washout and then the opposite treatment. Well-controlled RLS was defined as a score of less than 15 on the International Restless Legs Syndrome Study Group Rating Scale (IRLS) and Insomnia Disorder was defined by a self-reported combined Sleep Onset Latency (SOL) and Wake After Sleep Onset (WASO) of greater than 45 minutes and a Total Sleep Time (TST) of less than 7 hours. The primary outcome was actigraphically-derived TST, and secondary outcomes were Insomnia Severity Index (ISI) score and actigraphically-derived WASO. Data for all sleep metrics were collected at baseline and for the last two weeks of each treatment period.

Results

There were no significant improvements in actigraphically-derived TST (p = 0.58) or WASO (p = 0.99) while taking suvorexant compared to placebo. However, there was a significant reduction in insomnia symptoms, measured by the ISI, while taking suvorexant (p = 0.03). Moreover, exploratory analyses revealed a significant increase in self-reported TST (p = 0.01) and a significant reduction in nightly variability in TST (p = 0.03) while taking suvorexant. The most commonly reported side effect of suvorexant was fatigue (29.4%).

Conclusion

Though we did not observe a significant change between treatments in our primary endpoint of actigraphically-derived TST, our secondary and exploratory findings revealed promising support for suvorexant’s positive impact on self-reported quantity and quality of sleep in people with well-controlled RLS who continue to suffer from insomnia.

Support (if any)

Funded by an investigator-initiated grant from Merck Pharmaceuticals.
0394 The CANnabidiol Use for RElief of Short-Term Insomnia (CAN-REST). a Randomised Placebo-Controlled Clinical Trial
Authors: Hoyos Camilla , Marshall Nathaniel , Gordon Christopher , Yee Brendan , McGregor Iain , Grunstein Ronald R
Published: April 2024

Introduction

Cannabidiol (CBD) is a non-intoxicating cannabinoid which Australian regulators (TGA) have proposed down-scheduling to an over-the-counter pharmacist-only medicine pending positive efficacy trials. This trial compared the effect of 50mg and 100mg/day of an oral capsule CBD medicine with placebo over 8 weeks on insomnia symptoms, stress and mood.

Methods

This was a sponsor-initiated (NCT05253417) randomised, double-blind, 3-arm parallel superiority trial. This study was undertaken remotely without in-person visits. Participants were randomised (1:1:1) via a centralised computerised secure system. Potential participants were recruited through social and other media advertising with all participants initially directed to an online screening platform. Those who met initial eligibility were invited to a telehealth screening and informed consent visit. Inclusion criteria included adults aged 18-65 years with an Insomnia Severity Index (ISI) of 8-21. All questionnaires were collected through the online platform, and we couriered actigraphy devices and blinded study drug to participants. Safety blood and urinary drug screening was performed before and after treatment by local pathology services. The primary outcome was ISI and secondary outcomes were actigraphy-derived wake after sleep onset, stress and anxiety (DASS-21 questionnaire). The critical p-value for the primary hypotheses was < 0.025 and < 0.0083 for any of the 3 secondary outcomes to maintain an overall false discovery rate of 5% in each of the primary and secondary comparisons.

Results

Recruitment was ceased (n=206) when we reached our pre-defined sample size (50mg=64; 100mg=62; placebo=80; 146 females; mean age 47 years [19-65]; ISI=16.8 [8-21]). All participants were analysed under the intention-to-treat principle. At 8-week follow-up there was no difference between placebo and 100mg (-1.3, 95%CI [-2.8 to 0.3], p=0.10) or 50 mg (0.1, [-1.4 to 1.6], p=0.89) on the ISI. No secondary outcomes were positively affected (all p≥0.04). All adverse events were minor and consistent with the known pattern of events for CBD.

Conclusion

There was no significant effect of 8 weeks of a low-dose CBD medicine on insomnia symptoms in intention-to-treat analyses. It is possible that higher doses of CBD and identifying insomnia subgroups responsive to CBD may be effective and are warranted for future research.

Support (if any)

BOD Science, Australia
0396 Intensive Sleep Retraining and Sleep Deprivation for Treating Chronic Insomnia: A Randomized Controlled Trial
Authors: Le Bouthillier Jacques , Ivers Hans , Morin Charles
Published: April 2024

Introduction

Intensive sleep retraining (ISR) is a promising alternative treatment option for individuals who do not respond to standard cognitive behavioral therapy for insomnia. ISR capitalizes on two potential modes of actions: 1) a reconditioning between the bed and bedroom with rapid sleep onset and 2) an increase in the homeostatic sleep drive due to sleep deprivation. The present study compares the efficacy of ISR with total sleep deprivation for the treatment of chronic insomnia.

Methods

34 adults (10 males, 24 females, mean age 33.8 years) with chronic sleep-onset insomnia (with or without sleep maintenance difficulties) were randomized to ISR, total sleep deprivation (TSD) or a control (CTL) condition. The ISR treatment consisted of 42 sleep onset trials over a 21-hour sleep deprivation period, the TSD treatment consisted of an equivalent 21-hour sleep deprivation without sleep onset trials, and the CTL condition consisted of one night of habitual sleep in the laboratory. Participants completed several measures including the Insomnia Severity Index (ISI) and daily sleep diaries at pre-treatment, post-treatment, and at 1, 2, and 3 months after treatment.

Results

From pre-treatment to 3-month follow-up, significant and large decreases in insomnia severity were observed in both ISR (M = -5.91 units, p < .001, d = -1.99) and TSD (-5.41 units, p < .001, d = -1.82). Mean pre-treatment ISI scores (16.3) were in the moderate severity range and fell into the subthreshold insomnia category at post-treatment for both ISR (M = 12.4) and TSD (M = 12.6) groups and remained in that range at follow-up. From the same pre-treatment to 3-month follow-up period, a significant and moderate reduction in sleep onset latency was observed for the ISR group (M = -11.66 min, p < .05, d = -0.76), but not for the other two groups.

Conclusion

Both ISR and TSD were effective in reducing insomnia symptoms severity, but ISR produced a superior treatment response on sleep onset latency and this improvement was generally maintained up to 3 months after treatment.

Support (if any)

This research was supported by a grant from the Canadian Institutes of Health Research (#148410).
0397 Randomized Controlled Trial of Telehealth in Older Adults: Technology-assisted CBTi+, CBTi, and Sleep Hygiene
Authors: Schade Margeaux , Roberts Daniel , Gartenberg Daniel , Taylor Daniel , Emert Sarah , Nagy Samantha , Torres-Negron Alexia , Russell Michael , Melissa Melissa , Gamaldo Alyssa , Buxton Orfeu
Published: April 2024

Introduction

Of 34M US adults affected by insomnia, 75% are older adults. Cognitive Behavioral Therapy for Insomnia (CBTi) is recommended because polypharmacy and fall risks accompany pharmacotherapies. We evaluated telehealth CBTi with an interactive patient-therapist application, SleepSpace, which integrates data from wearables and Internet of Things (IoT) devices.

Methods

This RCT (NCT05015803) followed community-dwelling participants 60-90 years old with an Insomnia Severity Index (ISI) score ≥11. Absence of mild cognitive impairment was affirmed with the Montreal Cognitive Assessment (MoCA) Blind v.8 (score ≥ 18). Participants wore actigraphy and an Apple Watch throughout and independently completed a weekly electronic ISI. They attended 7 weekly, ~1hr video-conference sessions (1 intake, 6 procedural) with a clinical therapist. Participants were randomly assigned to one of 3 study conditions (age-, gender-stratified): 1) education about sleep hygiene only (20%; “Hygiene”), 2) telehealth CBTi (40%; “CBTi”), and 3) telehealth CBTi with phone/IoT platform application enhancement (40%; “CBTi+”) including meditations, sound machines, smart light bulbs, an electronic diary, with visualizations, metrics, and wearable data shared with participants in the CBTi+ condition. Linear mixed models compared ISI change across time by group.

Results

Of 60 individuals enrolled, 54 were randomized and retained (39F, mean±SD age=71±4y). ISI slopes for both CBTi (-.09/day) and CBTi+ (-.09/day) declined at a significantly steeper rate than Hygiene (-.05/day; each p<.05), but did not differ from one another. Significantly more CBTi+ participants exhibited full remission (ISI < 8; 18/21, 85.7%) than in the Hygiene group (5/11, 45.4%; p=.03 Fisher’s Exact); CBTi alone (16/22, 72.7%) did not significantly differ from Hygiene, although with limited statistical power. Diary-reported sleep measures to calculate self-reported sleep efficiency (sSE) in the final week at end of treatment revealed differences in mean±SD for Hygiene (81±05%) vs. CBTI (88±07%), and vs. CBTI+ (90±04%, p< 0.05, t-test).

Conclusion

This research supports the efficacy of a remote, technology-assisted telehealth CBTi platform to improve insomnia symptoms comparable to standard telehealth-CBTi in older adults with insomnia. The platform provides enhanced data access for therapists and opportunities for data-driven engagement with patients.

Support (if any)

R44 AG056250, UL1TR002014
0398 Impact of an Over-The-Counter "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality
Authors: Ponce Clairissa , Razon Amanda , Chao Joey , Nakagawa Sydney , Peterson Megan , Roque Angelina , Vanderpool Maya , Ferracane Michael , Olson Lisa
Published: April 2024

Introduction

Many over-the-counter products such as bubble baths, room sprays, and lotions claim they contain the pineal hormone melatonin and promote sleep. In this randomized, controlled, double-blind crossover trial we compared the impact of a commercial “sleep lotion” versus a placebo control lotion.

Methods

Participants applied lotions on two different nights, one hour before bedtime. To assess whether melatonin was absorbed through the skin and circulating systemically, we conducted enzyme linked immunosorbent assays on saliva samples to quantitate melatonin levels. We also assessed sleep quality the night after lotion application with a modified Pittsburgh Sleep Quality Index. The amount of melatonin in Dr. Teal’s Sleep Lotion was measured using High Performance Liquid Chromatography.

Results

Our sample of 63 undergraduate college students scored an average of 6.3 ± 2.7 on the Global Pittsburgh Sleep Quality Index, with 65% above the cutoff of 5 indicating poor sleep quality in the previous 30 days. The melatonin-containing sleep lotion dramatically impacted salivary melatonin levels, increasing them up to ~1000 fold compared to the placebo control lotion. Sleep quality in the overall group was not impacted by the lotion, but in a subsample of the poor sleepers, the lotion improved sleep quality. High Performance Liquid Chromatography of the sleep lotion revealed the presence of 2.4 ± 0.1 mg melatonin/g lotion, or a 0.24 ± 0.01% formulation.

Conclusion

Caution should be taken by consumers using over-the-counter melatonin lotions because the undisclosed dosage is high and well absorbed by the skin. Clinicaltrials.gov ID NCT06053385

Support (if any)
0399 Masked Tapering and Augmented CBTI Improves Benzodiazepine Receptor Agonist Discontinuation in a Randomized Trial
Authors: Fung Constance H , Alessi Cathy , Martin Jennifer , Josephson Karen , Kierlin Lara , Dzierzewski Joseph , Moore Alison , Badr M Safwan , Zeidler Michelle , Der-Mcleod Erin , Ghadimi Sara , Naeem Saadia , Partch Lisa , Guzman Andrew , Grinberg Austin , Smith Jason , Cook Ian , Kelly Monica , Mitchell Michael
Published: April 2024

Introduction

Benzodiazepines and benzodiazepine receptor agonists (BZRAs) are not recommended as first-line therapy for insomnia in older adults due to adverse events (e.g., falls). Although guidelines recommend cognitive behavioral therapy for insomnia (CBTI) and BZRA discontinuation, discontinuing BZRAs is challenging. To improve discontinuation success, we developed and tested a novel intervention (grounded in the science of known placebo effects of BZRAs), masked taper plus cognitive behavioral therapy-augmented program (MTcap), which masks the daily BZRA dose during tapering and adds novel cognitive and behavioral exercises targeting placebo effects to CBTI. We hypothesized that MTcap would increase BZRA discontinuation 1 week (PTX) and 6 months post-treatment (6M) compared to standard CBTI plus supervised (unmasked) gradual taper (SGT).

Methods

In a multi-site randomized trial, adults (>= 55 years) who use lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem at doses <= 8 mg diazepam-equivalent 2+ nights/week for >= 3 months for insomnia were randomized to MTcap versus SGT. Blinded research staff conducted PTX and 6M assessments including one-week medication logs and Insomnia Severity Index (ISI). Effects of MTcap versus SGT on BZRA discontinuation (primary outcome) were modeled with logistic regression. Using two-level mixed-effects models, we predicted additional outcomes (frequency [#days/week taken], dose, ISI) as a function of treatment group, site, treatment-site interaction, and time.

Results

188 participants (mean age 69.2 years, 34.6% female, mean frequency 5.9 days/week BZRA use, mean diazepam-equivalent 3.9 mg, mean ISI 14.0) were randomized (MTcap n=92, SGT n=96), with PTX and 6M follow-up rates of 94.7% and 93.6%, respectively. BZRA discontinuation for MTcap was superior to SGT at both PTX (MTcap=0.884, SGT=0.674; odds ratio [OR] 3.683, 95% CI 1.670, 8.122, p=.001) and 6M (MTcap=0.734, SGT=0.586; OR 1.955, 95% CI 1.033, 3.700, p=.039). Change in BZRA frequency was lower in MTcap than SGT at PTX (-1.32, 95% CI -2.07, -0.57, p<.001), but not 6M. ISI did not differ between these two active treatment groups at PTX or 6M.

Conclusion

Adding a masked taper and novel cognitive and behavioral exercises targeting placebo effects to traditional unmasked tapering plus CBTI results in markedly improved long-term BZRA discontinuation, with similar improvement in symptoms of insomnia.

Support (if any)

VAIIR 17-234, NIAR01AG057929, UL1TR001881
0400 Comparing the Effectiveness of Cannabis to Treat Sleep Impairments Between Those with and Without Sleep Disorders
Authors: Herens Allison , Kelly Erin , Hajjar Emily , Garber Gregory , Worster Brooke
Published: April 2024

Introduction

People are increasingly turning to cannabis to treat sleep disorders and symptoms. Despite mixed results in prior research, there is a small body of research indicating that cannabis could have a positive impact on sleep disorders, as well as people who have sleep issues that haven’t arisen to a clinical level warranting diagnosis. It’s important to understand if there are differences in the effectiveness of these therapies between those who have a sleep disorder diagnosis versus those who do not.

Methods

Using an online cross-sectional survey, individuals across Pennsylvania self-reported how they used cannabis to treat sleep disturbances (N=1034). Participants self-reported demographics, employment status and hours, sleep diagnoses, mental health diagnoses, cannabis use for sleep, symptoms of Cannabis Use Disorder using the Cannabis Use Disorder Identification Test Short Form (CUDIT-SF, range: 0-12), and their sleep disturbances using the Insomnia Severity Index (ISI, range: 0-28). To determine if a formal sleep diagnosis is associated with insomnia severity while using cannabis, a one-way ANCOVA was used to compare the difference between those with and without sleep diagnoses on the ISI on days that cannabis was used. Analyses controlled for age, gender, race, number of mental health diagnoses, cannabis use disorder, employment status, and job shifts that may negatively impact sleep.

Results

While using cannabis, both those with a diagnosis (M=9.56, SD=4.39) and without a diagnosis (M=8.56, SD=4.06) reported scores well below the clinical cutoff of 15 on the ISI. There was a significant effect of formal sleep disorders on ISI scores after controlling for stated covariates [F(1, 827)=6.69, p=.01]. While most participants used cannabis for sleep daily, a subset of the sample did not (n =222). Using a paired t-test, we compared if insomnia severity was significantly reduced on days when using cannabis compared to when not using. There was a significant increase in ISI scores on days that individuals did not use cannabis (M=13.43, SD=4.82) compared to days they used cannabis (M=8.76, SD=4.15), t(221)=14.85, p<.001.

Conclusion

While patients with formal sleep disorder diagnoses still report greater sleep issues, both groups showed significant improvement in their levels of impairment related to sleep while using cannabis.

Support (if any)
0403 Sleep Health Among Ukrainians: One Year After Russia’s Full-scale Invasion
Authors: Wang Shanshan , Hicks Madelyn , Barrett Emily , Martsenkovskyi Dmytro , Holonova Irina , Marchak Helga , Ishchenko Liudmyla , Fiedler Nancy , Haque Ubydul
Published: April 2024

Introduction

The study aims to investigate the prevalence of sleep disturbances, factors associated with sleep disturbances, and their impacts on quality of life among Ukrainian adults one year after Russia’s full-scale invasion.

Methods

Online survey data were collected using a quota sampling approach. A total of 2364 adults living in Ukraine aged 18-79 years were recruited from 5 April 2023 to 15 May 2023. Short sleep duration was defined as sleep duration ≤ 6 hours, and long sleep duration was defined as sleep duration ≥ 9 hours. Insomnia was assessed by the Insomnia Symptom Questionnaire. The World Health Organization Quality of Life Brief Version was used to assess the quality of life.

Results

The prevalence of short sleep duration, long sleep duration, and insomnia among the overall population was 39.4%, 6.9%, and 38.5%. Additionally, females (short sleep duration: adjusted odds ratio (OR)=1.38; insomnia: adjusted OR=2.11) and those with depressive symptoms (short sleep duration: adjusted OR=1.51; insomnia: adjusted OR=5.86) were more likely to have both short sleep duration and insomnia. Individuals working in essential public service are more likely to have short sleep duration than those not working in essential public service (adjusted OR=1.50). Both short sleep duration and insomnia were associated with lower quality of life in the physical and psychological domains. Insomnia was also linked to lower quality of life in the social relationships domain.

Conclusion

Sleep health among Ukrainians during the war is concerning. More studies are warranted to understand the impacts of the war on sleep health.

Support (if any)
0405 Prevalence of Poor Sleep Quality and Its Association with Smartphone Use in Singapore
Authors: Lim Chau Sian , Sim Hui Shan , How Choon How , Png Constance , Peh Andrew , Oh Hong Choon , Ong Rebecca
Published: April 2024

Introduction

Singapore, an urbanized multi-ethnic city-state in Southeast Asia with a very high smartphone penetrance, ranks among the most sleep deprived countries globally. This study examines the prevalence of poor sleep quality in Singapore and its association with smartphone use.

Methods

A cross-sectional household survey in eastern Singapore was conducted from October to December 2022. Subjects were included if they were residents aged 21 to 60 and own a smartphone. A simple random sampling design and a proportionate stratified approach by dwelling type was used to select 1200 households for the survey. Key variable data collected included sleep quality as measured using the Pittsburgh Sleep Quality Index (PSQI), problematic smartphone use (PSU) using the Smartphone Addiction Scale – Short Version, and smartphone usage patterns. Other variables included psychological symptoms of depression, anxiety, and stress using validated scales. Social support, sociodemographic, and lifestyle data were also recorded. Significant factors from bivariate analyses were included in adjusted multivariable logistic regression models.

Results

400 participants (200 male, 200 female) were surveyed. Prevalence of poor sleep quality was 21%. PSU was associated with poor sleep quality (aOR 2.73, 95% CI 1.61 – 4.64, p< 0.001). Daily use of a smartphone in bed before sleep was associated with poorer sleep quality (aOR 2.70, 95% CI: 1.15 – 6.34, p=0.023), compared to no smartphone use. After lights out, even occasional smartphone use was associated with increased likelihood of having poor sleep quality (aOR 3.02, 95% CI: 1.31 – 6.95, p=0.010). Spending >4 hours compared to < 2h per day on the smartphone was also linked with poorer sleep quality (aOR 2.50, 95% CI: 1.15–5.43, p=0.020). Conversely, making smartphone calls to family (aOR 0.49, 95% CI: 0.25 – 0.96, p=0.040) or friends (aOR 0.39, 95% CI: 0.21 – 0.74, p=0.004) was negatively associated with poor sleep quality.

Conclusion

About a fifth of adults in Singapore suffer from poor sleep quality and it is significantly associated with smartphone usage patterns. It remains plausible that smartphone-mediated social connections could contribute to improved sleep quality; further research is required to explore this.

Support (if any)

This research was supported by CGH’s Joint Research and Innovation Grant (RIG202110-003PR).
0406 Demographic Factors Are Unrelated to Interest in VA BSM Services: Results of a Quality Improvement Initiative
Authors: Walia Neal , Erickson Alexander , Kelly Monica , McGowan Sarah Kate , Martin Jennifer , Zeidler Michelle , Ryden Armand , Grinberg Austin
Published: April 2024

Introduction

High rates of sleep disorders in Veterans increases demand for behavioral sleep medicine (BSM) services and clinical efficiency is essential to improving access to care. An ongoing quality improvement project assessing the utility of a clinic orientation group reduced intake no-show rates within a large Department of Veterans Affairs (VA) BSM clinic and revealed that some Veterans declined services after learning more about the treatment offerings. The goal of this analysis was to identify characteristics of patients following completion of the orientation group that predicted acceptance of BSM services to address potential disparities in engagement with BSM.

Methods

Data from 228 Veterans referred for BSM services were analyzed. Individuals were coded as interested (scheduling or attending intake) vs. disinterested (declining or failing to attend intake) in BSM. Predictors included 1) race (0=white, 1=BIPOC), 2) Age, and 3) medical complexity based on VA disability rating and care assessment need (CAN) score (score predicting risk of hospitalization within the next year).

Results

Of the 228 Veterans reviewed, most patients were male (n =183, 84%) and identified as white (n=73; 32%), followed by Hispanic/Latinx (n=48, 21%), and Black (n=44, 19.3%) race/ethnicity. Average age was 51.4 years; SD=15.23, range [22,95]). A total of 73% (n=166) were interested in BSM services after the orientation group and 27% (n=62) were disinterested. Chi-square and logistic regression results indicated no differences between groups across predictors explored (p-values 0.34-0.80) when evaluated individually or in a multivariable model. No-show to intake appointments fell from 21% (n=74 out of 353 in the 11 months prior to initiation of the orientation group to 7.5% (17/267) after the orientation group was initiated.

Conclusion

Over one quarter of veterans referred to a BSM orientation group declined BSM services after learning more about services offered. Reduced intake no-shows suggests improved clinic efficiency. We did not identify differences in acceptance of services based on race/ethnicity, age, or medical complexity. Although the number of women in this sample was too small for statistical analysis, gender differences should be evaluated with a larger sample. Additional evaluations will consider whether disparities exist elsewhere in the referral pathway.

Support (if any)

VAGLAHS GRECC
0407 Physician Heal Thyself – a Novel Approach to Improve Sleep in Post-Graduate Medical Trainees
Authors: Epstein Matthew , Levine Jeffrey , Kellenberger Katherine , Chiu Stephanie , Kendra Moira , Landsman Melissa , Cerrone Federico
Published: April 2024

Introduction

Post-graduate medical training entails long work hours, overnight shift work, nocturnal sleep disruptions and insufficient sleep. Mandatory work hour restrictions have had some benefits, but ongoing acute and chronic sleep deprivation in physician trainees continues to impair physical and mental health, impede work performance and contribute to patient safety concerns. Sleep deprivation is increasingly common regardless of profession, and most adults fail to get adequate sleep, in part due to worsening sleep hygiene. We sought to determine whether physician trainees might be similarly impacted by the plethora of contemporary, maladaptive lifestyle habits and behaviors that contribute to insomnia in the general population.

Methods

We recently developed and validated a comprehensive sleep hygiene survey (Atlantic Sleep Hygiene Questionnaire, ASHQ) consisting of 20 detrimental sleep habits based on a critical analysis of the sleep hygiene literature. The ASHQ was administered to 97 residents and fellows at 2 teaching institutions encompassing 13 different specialties. Trainees also completed a single item sleep quality assessment (Sleep Quality Score, SQS) and a screening tool for insomnia (Insomnia Severity Index, ISI). ASHQ scores were summarized and compared to SQS and ISI survey results, and correlations were analyzed for each assessment. Trainees were provided immediate feedback following completion of the survey.

Results

ASHQ and ISI scores were elevated in a majority of the trainees, indicating a high prevalence of detrimental sleep habits and insomnia, respectively. ASHQ scores were significantly associated with SQS and ISI scores, and there was a direct correlation between poor sleep hygiene, worse sleep quality and insomnia.

Conclusion

Detrimental sleep habits were highly prevalent in this cohort of post-graduate medical trainees, and poor sleep hygiene correlated with both subjective sleep quality and insomnia. ASHQ may be a useful instrument to identify and improve poor sleep hygiene in this already sleep-deprived population.

Support (if any)
0410 Daily Shifts in Spiritual and Social Connection Are Associated with Nigh-to-Night Changes in Sleep in Young Adults
Authors: Reese Matthew , Kay Daniel , Duraccio Kara , Yang Chongming , Nielsen Jared
Published: April 2024

Introduction

Feeling connected, both spiritually and socially, contributes to positive health outcomes. In contrast, loneliness, the absence of social connection, is negatively associated with healthy sleep outcomes. Spiritual connection encompasses relationships with oneself, others, a higher power, or nature. The depth of these connections depends on self-awareness and soul-searching, shaping the level of intimacy but these internal feelings about personal spiritual connection are often overlooked.. This study examines the daily associations of feelings of spiritual and social connection with nightly sleep features in young adults (M=23+/-4 years of age).

Methods

This study included individuals with autism (n=33), social anxiety (n=28), and no diagnoses (n=33) Participants completed evening and morning diaries for 9 months while concurrently wearing an actigraph. The evening diary asked about daytime feelings of spiritual and social (digital and in-person) connection. Sleep diary measures included sleep onset latency, wake after sleep onset, total sleep time, and sleep efficiency. Multilevel linear modeling was used to explore daily/nightly associations between spiritual and social connection and sleep variables.

Results

Higher spiritual connection was associated with shorter sleep onset latency and (p=0.007) greater total sleep time (p=0.010), measured by sleep diary. Higher in-person social connection was associated with shorter total sleep time (p=0.010), measured by actigraphy. Higher digital social connection was associated with lower sleep efficiency (p=0.005), measured by actigraphy and lower self-reported wake after sleep onset (p=0.002). All other findings examining the daily/nightly associations between connection indexes and sleep variables were non-significant.

Conclusion

This study underscores the importance of considering internal spiritual connections alongside traditional measures of connection. As higher spiritual connection was associated with perceptions of sleep improvements (whereas in-person connection as associated with behavioral observations of sleep), spiritual connection could be a particularly salient intervention target for young adults with insomnia with sleep-state misperception. Digital social connection, however, revealed potential drawbacks, which highlights that even in the presence of connection using digital devices, electronic use may be deleterious to sleep.

Support (if any)
0411 The Effect of Non-pharmacological Interventions for Sleep During Pregnancy: A Systematic Review and Meta-analysis
Authors: Chen Pei , Wang Yueying , Wang Bixuan , yuan Jinjin , Lenon Pia Pauline , Bourjeily Ghada , Park Chang , Zhu Bingqian , Izci-Balserak Bilgay
Published: April 2024

Introduction

Sleep problems are common during pregnancy. Maintaining good sleep is critical to maternal and fetal health. This systematic review and meta-analysis aimed to quantify the effective non-pharmacological interventions for sleep in the pregnant population.

Methods

This review was performed following PRISMA and registered in PROSPERO (CRD42022372289). Studies were identified from PubMed, CINAHL, Embase, Web of Science, and Cochrane from inception to October 17, 2023 for intervention studies. Studies reporting non-pharmacological interventions and sleep-related outcomes were selected.

Results

Forty-two studies (N=3,378 women) were included. The efficacy of non-pharmacological interventions in terms of sleep quality showed a significant improvement (SMD=-1.17; 95% CI=-1.57 to -0.77; I2=97%; k=34). Interventions during the second trimester (SMD=-2.03; 95% CI=-3.26 to -0.79; I2=92%; k=3), third trimester (SMD=-1.51; 95% CI=-2.56 to -0.46; I2=95%; k=4), and the combined second and third trimester (SMD=-1.20; 95% CI=-1.87 to -0.54; I2=98%; k=18) demonstrated significant improvements in sleep quality. Both exercise (SMD=-0.73; 95% CI=-1.22 to -0.25; I2=90%; k=8) and cognitive behavioral therapy for insomnia (CBT-I) (SMD=-1.41; 95% CI=-2.56 to -0.26; I2=86%; k=3) led to significant improvements in sleep quality. These interventions also resulted in an increase in subjective nocturnal sleep duration (SMD=0.59; 95% CI=0.11 to 1.07; I2=86%; k=8), particularly with the use of eyemasks and earplugs during the third trimester (SMD=0.41; 95% CI=0.22 to 0.60; I2=46%; k=2), and improved subjective sleep efficiency during the combined second and third trimesters (SMD=0.92; 95% CI=0.29 to 1.52; I2=24%; k=2). Additionally, these interventions reduced subjective sleep onset latency (SMD=-0.53; 95% CI=-0.90 to -0.15; I2=49%; k=2). Furthermore, there was an increase in objective total time in bed during the third trimester (SMD=0.30; 95% CI=0.02 to 0.57; I2=0%; k=2). Objective sleep efficiency also saw a significant increase due to the interventions (SMD=0.19; 95% CI=0.01 to 0.38; I2=32%; k=5), especially during the combined second and third trimester (SMD=0.60; 95% CI=0.17 to 1.04; I2=0%; k=2).

Conclusion

Overall, non-pharmacological approaches appear to be beneficial for sleep-related outcomes in pregnant women. Future research should investigate intervention effects across trimesters and explore sleep-related outcomes, incorporating subjective and objective data.

Support (if any)
0414 Dose-response of Daridorexant in Insomnia Disorder: A Meta-analysis of Phase 2 and 3 Studies
Authors: McCall William , Bassetti Claudio , Braunstein Guy , Hedner Jan , Laurent Johann , Olivieri Antonio , Luyet Pierre-Philippe
Published: April 2024

Introduction

Daridorexant is a dual orexin receptor antagonist approved for the treatment of insomnia disorder at two dose levels (25 and 50 mg). Dose-efficacy and -safety response relationships were evaluated using data from Phase 2 and 3 studies.

Methods

Data from one Phase 2 study evaluating daridorexant 5 mg, 10 mg, 25 mg, 50 mg and placebo for 1 month, and two Phase 3 studies investigating daridorexant 10 mg and 25 mg or 25 mg and 50 mg vs placebo for 3 months were used. Dose-response analyses at 1 month of double-blind treatment were performed using two statistical approaches: a linear regression approach based on individual patient data and a two-stage meta-analysis approach based on aggregated data. Efficacy endpoints were polysomnography-determined wake after sleep onset (WASO) and latency to persistent sleep (LPS), self-reported total sleep time and the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) total score (Phase 3 only for the latter endpoint). Safety endpoints were the percentage of patients with at least one adverse event (AE) and at least one AE corresponding to somnolence/fatigue during the first month of the double-blind study periods.

Results

Pooled efficacy analyses included 2153 patients randomized to placebo (n=678), daridorexant 5 mg (n=60), 10 mg (n=365), 25 mg (n=679) and 50 mg (n=371). The dose-response was significant for both statistical approaches in the observed range of 0 to 50 mg at Month 1 for all four efficacy endpoints (p< 0.01). All dose-response relationships were linear except for LPS (two-stage meta-analysis) which showed a change in slope after daridorexant 10 mg, without reaching a plateau. No significant dose-response relationship was observed for any AEs during the first month; results were consistent across methods (p>0.05). AEs corresponding to somnolence/fatigue were low at all doses and relaxing the linear assumption (two-stage meta-analysis) showed no evidence of dose-dependency (p=0.369).

Conclusion

The data support a favorable benefit-risk balance for daridorexant 25 mg and 50 mg at 1 month of treatment. The greater efficacy and similar safety at 50 vs 25 mg support the use of daridorexant 50 mg as a starting dose in patients with insomnia disorder.

Support (if any)

Idorsia Pharmaceuticals Ltd
0415 Real-world Data and Health-related Quality of Life in Treatment of Chronic Insomnia with Daridorexant
Authors: Winter Yaroslav , Apel David , Fietze Ingo
Published: April 2024

Introduction

Daridorexant was approved by FDA and EMA for the treatment of chronic insomnia. It is a new dual orexin-receptor anatgonist, which demonstrated its clinical efficacy and safety in randomized controlled trials. The real-world data including its influence on the health-related quality of life (HrQol) are not yet available. In this prospective observational study we investigate the influence of daridorexant on HrQol in patients with chronic insomnia.

Methods

Patients with chronic insomnia diagnosed following the DSM V criteria were included in the observational study in terms of the Mainz Sleep Registry (MAINZ-SLEEPREG). All patients received the standard dosis of daridorexant of 50mg/night. The evaluation of clinical parameters and HrQoL was performed before, as well as three and six months after the initiation of daridorexant. The collected night-time efficacy endpoints included wake time after sleep onset (WASO), latency to persistent sleep (LPS), total sleep time and self-reported total sleep time. The EuroQol5D (EQ5D Index and EQVAS: visual analogue scale) was used to evaluate HrQol.

Results

Study participants (n=63) were 52.7±11.0 years old and 58.7% of them were females. All applied night-time efficacy measures (WASO, LPF, total sleep and self-reported sleep time) showed a significant improvement by approximately 20-40% at the time points after three and six months (p< 0.05). At the follow-up after three and six months the EQ5D Index values (0.71±0.17 and 0.72±0.15, correspondingly) improved on daridorexant by 18% in comparison to baseline (0.61±0.17, p< 0.05). Similar increase of HrQol was observed on EQVAS (62.2±16.5 at baseline versus 73.9±19.8 and 74.6±18.9, p< 0.05).

Conclusion

The data from this real-word study shows that daridorexant not only significantly improves the night-time sleep of patients with chronic insomnia but it also increases their HrQol. These findings encourage farther real-world studies to investigate the role of daridorexant in the treatment of chronic insomnia in broader populations.

Support (if any)
0419 The Publication Profile of Randomized Clinical Trials for the Treatment of Insomnia
Authors: Kakazu Viviane , Assis Marcia , Bacelar Andrea , Bezerra Andréia , Ciutti Giovanna , Galduróz José , Conway Silvia , Drager Luciano , Khoury Mariana , Leite Ingrid , Luciano Ygor , Poyares Dalva , Tufik Sergio , Pires Gabriel
Published: April 2024

Introduction

There is a continuous need for the development and refinement of therapeutic interventions for insomnia. The implementation of these new treatments depends on robust results, and the publication of randomized controlled trials (RCTs) is often a requirement. The aim of this study is to describe the publication profile of randomized controlled trials (RCTs) about therapeutic interventions for insomnia.

Methods

A systematic review was performed on PubMed and Web of Science, searching for RCTs about pharmacological and non-pharmacological treatments for non-comorbid insomnia in adults. A bibliographic analysis was performed based on the publication year and the characteristics of the treatments evaluated in each included study.

Results

The sample comprised 64 RCTs related to pharmacological and 74 to non-pharmacological treatments. The individual interventions with the greatest publication outputs are digital cognitive-behavioral therapy (dCBTi, n=35), in person CBT-I (n=28) and zolpidem (n=22). Regarding zolpidem, the first RCT was published in 1993, the median publication year is 2008 and 0.71±0.97 RCTs were published per year. The first RCT about in-person CBTi was published in 2001, the median publication year is 2018 and 0.90±1.1 RCTs were published per year. The first RCT about dCBT-I was published in 2009, the median publication year is 2019 and 1.13±1.91 RCTs were published per year.

Conclusion

The publication output for pharmacological interventions has been substantial for zolpidem and DORAs only, while most other drug categories have not been analyzed by a significant number of studies. A remarkable increase in the amount of RCTs about CBT-I (especially dCBT-I) has been observed. The possibility of sponsorship bias should be considered as an important driver for the development of new digital interventions for insomnia.

Support (if any)

VAK, AGB, GLRC, MPK, IGAL, YML, DP, ST and GNP are supported by the Associação Fundo de Incentivo à Pesquisa (AFIP). VAK, MPK and YML are grant recipients from the São Paulo Research Foundation (FAPESP; grant 2022/00328-5, 2023/07603-4, 2022/08677-9). GLRC, JCG and DP are fellowship recipients from the is Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Brazil. This work was funded by the Brazilian Sleep Association (Associação Brasileira do Sono – ABS).
0420 Clinician Experience with Implementing Brief Behavioral Treatment for Insomnia
Authors: Hough Caroline , Beyer Nicole , Hruska Kristina , Rodriguez Keri , Bramoweth Adam
Published: April 2024

Introduction

Chronic insomnia significantly affects health, functioning, and quality of life for many Veterans, yet access to evidence-based behavioral insomnia care remains limited. This Hybrid III stepped-wedge trial aims to test the implementation and treatment effectiveness of delivering Brief Behavioral Treatment for Insomnia (BBTI) into the VA Primary Care Mental Health Integration (PCMHI) setting.

Methods

Enrolled clinicians, across the four sites (n=16) were interviewed after the 12-month implementation phase. The semi-structured qualitative interview focused on clinician experiences during the implementation phase, how access to the bundle of implementation strategies influenced their delivery of BBTI in PCMHI, specific strategies that were most or least helpful, and barriers that impeded implementation efforts. Interviews were transcribed and summarized using rapid qualitative analysis. Interview data was synthesized and organized into a template based on applicable Expert Recommendations for Implementing Change (ERIC) strategies.

Results

Participating clinicians rated BBTI as highly compatible in PCMHI settings, adaptable in its delivery, and an important intervention for meeting Veterans’ needs. Clinicians felt supported during the implementation of BBTI through access to a variety of educational resources. The most frequently cited barrier to implementation was work infrastructure difficulties, including high caseloads and inadequate staffing. Another common barrier was Veterans’ co-morbid diagnoses and other health issues taking precedence over insomnia care. Lastly, multiple sites struggled to engage primary care, and other referring, providers. To facilitate sustainable delivery of BBTI in the future, clinicians requested continued access to BBTI resources and education materials and recommended ongoing group discussion and consultation amongst PCMHI clinicians.

Conclusion

Clinicians rated BBTI as a high-quality intervention with high mission alignment and were eager to continue providing BBTI after the study’s conclusion, despite implementation barriers. When integrated with implementation outcomes (i.e., reach, effectiveness, adoption, implementation, maintenance), front-line clinician perspectives and feedback can support efforts to foster sustainable delivery of BBTI and can inform a larger-scale rollout of BBTI into the VA PCMHI setting.

Support (if any)

VA Health Services Research and Development (I01 HX003096; PI Bramoweth)
0421 Do Online Trainings Really Work? One Year Follow-up of Providers Who Completed CBTI Training Through CBTIweb
Authors: Wilkerson Allison , Taylor Daniel , Lin Tao , Pruiksma Kristi , Dietch Jessica , Wardle-Pinkston Sophie
Published: April 2024

Introduction

Online trainings to learn new skills and interventions are growing in popularity for mental health practitioners. Such platforms show promise for exponentially improving dissemination of evidence-based treatments and subsequent accessibility for individuals in need of effective care. However, minimal research has been done on the long-term impact of these trainings. CBTIweb was developed to train providers in cognitive behavioral therapy for insomnia (CBTI) and launched on April 1, 2020. The aim of the present study was to assess retention of knowledge about insomnia and CBTI and implementation of CBTI by providers approximately one year following their completion of CBTIweb.

Methods

Providers who completed CBTIweb within the first three months following the launch (N = 624) were contacted via email. Upon consent they were asked to answer the same test questions that were given as part of the CBTIweb training and complete an online survey. The survey included number of patients receiving CBTI in past year, items related to self-efficacy for CBTI delivery, barriers to implementing CBTI into their practice, and desire for resources that would increase effective implementation.

Results

Of the 624 providers who were contacted, 233 completed the test questions and survey. The vast majority passed the test (87%) and reported using CBTI in their practice since completing training (73%). Self-efficacy was positively associated with CBTI use. The most commonly cited facilitator of implementation was ease of access to handouts and other web-based tools designed to improve interaction with patients. The most common barriers were time required to prepare for sessions, difficulty finding supervision, accommodating comorbid conditions, and low patient buy-in.

Conclusion

The majority of providers who completed CBTIweb retained the information they learned in the training and implemented CBTI into their practice, indicating this online training format is a useful avenue for disseminating and implementing CBTI and other evidence-based treatments. Development of resources that would streamline delivery of CBTI, including simplifying patient handouts to minimize therapist preparation time, would likely lead to an increase in use of CBTI. Other barriers, including accessibility of supervision and low patient buy-in, warrant further investigation.

Support (if any)

W8IXWH1710165