bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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

Abstract

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 &lt; 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&lt;.001). The same trend was observed for shorter sleep duration (Q1-Q4 ORs:1.6-2.4, p&lt;.001), sleep apnea (Q1-Q4 ORs:1.4-2.4, p&lt;.0001) and snoring (Q1-Q4 ORs:1.3-1.8, p&lt;.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

Abstract

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) &gt;=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

Abstract

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

Abstract

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&lt; 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&gt;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&lt; 13) increased from 29% to 50 after the same period of long-term follow-up, and those with moderate-to-severe daytime fatigue (FFS&gt;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&lt; 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

Abstract

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

Abstract

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

Abstract

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 &gt;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 &gt;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&lt;.001) and anxiety (p&lt;.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