bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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 &lt; 0.025 and &lt; 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

Abstract

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 &lt; .001, d = -1.99) and TSD (-5.41 units, p &lt; .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 &lt; .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

Abstract

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&lt;.05), but did not differ from one another. Significantly more CBTi+ participants exhibited full remission (ISI &lt; 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&lt; 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

Abstract

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

Abstract

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 (&gt;= 55 years) who use lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem at doses &lt;= 8 mg diazepam-equivalent 2+ nights/week for &gt;= 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&lt;.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

Abstract

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&lt;.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

Abstract

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

Abstract

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&lt; 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 &gt;4 hours compared to &lt; 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

Abstract

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