bluuebunny/crossref_metadata_2025_split huggingface dataset:
0452 Lemborexant Treatment of Older Adults with Insomnia and Objective Short Sleep: Rates of Response and Remission
Authors: Edinger Jack , Krystal Andrew , Kumar Dinesh , Pappadopulos Elizabeth , Lundwall Christie , Moline Margaret 
Published: May 2022

Abstract

Introduction
In Phase 3 Study 304 (NCT02783729), lemborexant (LEM) provided significant benefit versus placebo (PBO) on polysomnographic (PSG) endpoints and sleep diary-based sleep onset and maintenance outcomes over 1mo in subjects with insomnia disorder. The study also included the Insomnia Severity Index (ISI) to ensure sufficient insomnia severity at baseline (ISI total score ≥13) and for use as an outcome measure. Subjects met criteria for insomnia disorder and were confirmed to spend between 7-9 hours in bed. Subjects had insomnia with objective short sleep (ISS; [total sleep time; TST] &lt;6hrs) or objective long sleep (TST ≥6hrs). Since patients with ISS may respond less well to therapeutic approaches such as cognitive behavioral therapy for insomnia (CBT-I), we examined rates of response and remission with LEM as defined by the ISI in the ISS subgroup.

Methods
Study 304 was a 1mo, randomized, double-blind, PBO- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006). Subjects received PBO, LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate extended-release 6.25 mg (not reported). Baseline PSGs were obtained during a single-blind PBO run-in, followed by paired PSGs on Nights 1/2 and Nights 29/30. The ISI was given at baseline and end of treatment. For these post-hoc analyses, responders were defined as subjects whose decrease from baseline on the ISI was ≥7pts, while remitters achieved ISI total scores &lt;8pts. LEM5 and LEM10 vs PBO differences were evaluated using chi-square tests.

Results
525/743 (70.66%) of subjects in the PBO/LEM groups were in the ISS subgroup. For LEM5, 99/176 (56.25%) were responders and 49/176 (27.84%) were remitters. For LEM10, 97/180 (53.89%) were responders and 50/180 (27.78%) were remitters. For the PBO group, 59/140 (42.14%) were responders and 21/140 (15.00%) were remitters. The responder and remitter rates for LEM5 and LEM10 were statistically significantly greater than those for PBO (all P&lt;0.05).

Conclusion
Older adults with ISS achieved clinically meaningful improvement with LEM as assessed at the end of one month of treatment, with nearly 30% considered remitters and &gt;50% considered treatment responders. LEM is a potential therapy for ISS patients who may have limited response to CBT-I.

Support (If Any)
Eisai Inc.
0462 Baseline Sleep Disturbance and Inability to Discontinue Chronic Hypnotic Use
Authors: Koshorek Gail , Parashar Vartika , Roth Thomas , Roehrs Timothy 
Published: May 2022

Abstract

Introduction
Clinicians prescribing hypnotics remain concerned regarding the inability to discontinue hypnotics after chronic use, which has never been directly tested in a controlled prospective study using self-administration choice methodology. This study reports on difficulty discontinuing medication as a function of basal sleep disturbance in insomnia subjects instructed to stop taking their study medication after 6 months of nightly use.

Methods
DSM-V diagnosed insomnia subjects, aged 23-61 yrs, (n=39, 34 females), with no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the trial. Following a screening polysomnogram participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg), or placebo nightly for 6 months (blinded groups A: n=15, B: n=11, C: n=13). After 6 months, nightly use, over a 2-week choice period, they were instructed to discontinue hypnotic use, but if necessary, to self-administer either 1, 2, or 3 capsules of their assigned “blinded” medication (zolpidem XR 6.25 mg, 6.25 mg, placebo; eszopiclone 2 mg, 1 mg, placebo as capsules 1, 2 and 3 respectively; or 3 placebos).

Results
Over the 14 nights 20 subjects took zero (51%) capsules; among the 19 taking capsules the median number chosen was 3. Most took one capsule per night; 6 took &gt; 1 capsules on a given night. Importantly 1 subject took every capsule (42) available. Overall, the number of capsules taken declined from week 1 to 2 (p&lt; .005). Those with baseline PSG SE &lt;81% did not reduce capsule choice from week 1 to 2 (p&lt;.02). Group A choose more capsules than groups B and C (p&lt;.01).

Conclusion
The majority (85%) of the participants discontinued 6-month nightly hypnotic use (i.e. took &lt; 6 total capsules over the 14 discontinuation nights) and among those taking capsules the rate declined from week 1 to 2. Baseline SE &lt;81% may help identify those with difficulty discontinuing.

Support (If Any)
NIDA, grant#: R01DA038177 awarded to Dr. Roehrs.
0465 Exploring Differences in Self-Report Sleep Measures in Adults with Insomnia who Use or Do Not Use Sleep Medication
Authors: Tutek Joshua , Tully Isabelle , Simpson Norah , Manber Rachel 
Published: May 2022

Abstract

Introduction
Adults seeking non-pharmacological treatment for insomnia often present for care already taking prescription medication for sleep. Understanding how such patients differ from those who do not use medication could be useful for guiding treatment. This study examined associations between sleep medication use and measures of self-report sleep characteristics at baseline in an RCT of cognitive behavioral therapy for insomnia (CBTI).

Methods
We examined baseline data from 237 middle-to-older-aged adults with insomnia disorder (175 women, M age = 63.17) enrolled in the ongoing RCT on Effectiveness of Stepped-Care Sleep Therapy (RESTING). Participants were dichotomized by whether they reported taking at least one prescription medication for sleep. Sleep measures included the Insomnia Severity Index (ISI), PROMIS Sleep-Related Impairment short form, Epworth Sleepiness Scale (ESS), Cognitive Presleep Arousal Scale, Dysfunctional Attitudes and Beliefs About Sleep Scale, and two weeks of sleep diaries yielding average nightly sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality ratings. MANOVA compared medication users and non-users across sleep measures.

Results
Seventy-seven (32.5%) participants reported taking at least one prescription medication for sleep at baseline. MANOVA results indicated that sleep measures collectively differed by medication use, F(9, 226) = 3.74, p &lt; .001; Wilk’s Λ = .87, partial η-sqd = .13. Bonferroni-adjusted follow-up comparisons (p &lt; .005) found that only ESS significantly differed between medication users and non-users, F(1, 234) = 15.17, p &lt; .001; partial η-sqd = .06. Medication users had lower sleepiness scores (M = 5.86, SD = 4.68) than non-users (M = 8.46, SD = 4.84). The association between medication use and less daytime sleepiness was maintained after adjusting for ISI.

Conclusion
Sleep medication use displayed little association with sleep measures in adults about to undergo CBTI, excepting endorsement of less daytime sleepiness by medication users. While more research is needed to understand the implications of sleep medication use for adults engaging in CBTI, these initial findings suggest that CBTI therapists should be thoughtful about sleepiness in non-medication users, and the potential emergence of sleepiness among patients who engage in sleep medication taper while in treatment.

Support (If Any)
1R01AG057500
0473 The impact on treatment adherence of adding a bedpartner to CBT-I: preliminary findings from a randomised controlled trial (Project REST)
Authors: Drummond Sean , Jenkins Melissa , Mellor Alix , Norton Peter , Baucom Donald , Bei Bei 
Published: May 2022

Abstract

Introduction
Cognitive Behavioural Therapy for Insomnia (CBT-I) includes often difficult-to-implement behavioural change, and this can result in poor adherence to treatment recommendations. In other CBTs, adding a significant other to “individual” therapy increases adherence. Here, we report preliminary findings from a randomised controlled trial (RCT) of a newly developed partner-assisted CBT-I.

Methods
117 adults with DSM-5 Insomnia Disorder (age M±SD=47.9±15.3yrs; 73F) and their live-in partners participated in a single-blind parallel RCT. They were assigned 1:1:1 to 7wk individual CBT-I (Ind-CBTI), partner-assisted CBT-I (PA-CBTI), or sleep management control (CTRL) conditions. Participants completed daily sleep diary throughout the intervention. Adherence in CBT-I conditions was assessed for Sleep Restriction Therapy (deviation from bed and wake times, naps) and Stimulus Control Therapy (wake time-in-bed during daytime, overnight, and after final morning awakening). Intention-to-treat, mixed effects models examined differences in adherence for “Build” (initial phase to build sleep debt) and “Maintain” (starting the first week when sleep opportunity was titrated upwards) stages of therapy.

Results
All conditions showed significant increase in sleep efficiency (p&lt;.001), with significantly faster increase in Ind-CBTI and PA-CBTI compared to CTRL (ps&lt;.001). Sleep Restriction Therapy: Build stage (vs Maintain) had greater adherence to prescribed wake time (p=.045); Condition by Stage interaction (p=.010) showed PA-CBTI (vs Ind-CBTI) adhered better in avoiding naps during Build (vs Maintain). Stimulus Control Therapy: PA-CBTI (vs Ind-CBTI) adhered better to avoiding daytime wake time-in-bed (p=.017), especially during Build (interaction p=.071); Condition by Stage interaction (p=.017) showed PA-CBTI (vs Ind-CBTI) adhered better to avoiding overnight wake time-in-bed during Maintain (vs Build). Both conditions had better adherence to avoiding daytime and wake time-in-bed after final awakening during Maintain (vs Build) Stage (ps&lt;.001).

Conclusion
Adherence to CBT-I includes multiple indicators showing distinct features as the intervention progresses across different stages. Aspects of adherence appear modifiable, and adding bedpartners to CBT-I improved adherence to specific aspects of the intervention (i.e., avoiding naps, daytime wake time-in-bed, overnight wake time-in-bed). The Build and Maintain stages of treatment appear to be associated with better adherence to different aspects of the intervention (Sleep Restriction Therapy and Stimulus Control Therapy, respectively).

Support (If Any)
NHMRC grant APP1105458 (SPAD,DHB,PJN), APP1140299 (BB)Trial registration: ACTRN12616000586415
0474 Three-arm randomised controlled trial of Cognitive Behavioural Therapy for Insomnia, a responsive bassinet, and sleep hygiene for preventing postpartum insomnia: Preliminary findings on maternal insomnia and sleep outcomes (Study for Mother-Infant Sleep)
Authors: Quin Nina , Tikotzky Liat , Astbury Laura , Stafford Lesley , Fisher Jane , Wiley Joshua , Bei Bei 
Published: May 2022

Abstract

Introduction
Insomnia symptoms are common during the perinatal period and are linked to adverse parent/infant outcomes. This single-blind 3-arm randomised controlled trial examined how two interventions targeting different mechanisms prevent postpartum insomnia compared to sleep hygiene control. Trial registration: ACTRN12619001166167.

Methods
Participants were nulliparous females 26-32 weeks gestation with self-reported insomnia symptoms (Insomnia Severity Index [ISI] scores ≥ 8). Participants were randomized 1:1:1 to: (a) a responsive bassinet designed to support infant sleep until 6 months postpartum (RB), (b) therapist-assisted cognitive behavioural therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (c) a sleep hygiene booklet (control condition; CTRL). Outcomes were assessed at baseline (T1), 35-36 weeks gestation (T2), and 2, 6, and 12 months postpartum (T3-T5). The primary outcome is ISI scores averaged T3-T5. Secondary outcomes are PROMIS Sleep Disturbance (SDI), Sleep-Related Impairment (SRI), and self-report total sleep time (TST). We report preliminary results on T1-T4 as T5 is ongoing. Multiple regression analyses controlling for baseline outcomes examined group differences at post-baseline timepoints.

Results
127 participants were randomised (age M±SD=32.62±3.49; RB = 44, CBT-I = 42, CTRL = 41), and 118 (92.9%) completed T4. Compared to CTRL, CBT-I had lower ISI, SDI, and SRI at T2, T3, and T4 (all p&lt;.05 except p=.07 and .06 for ISI at T3 and T4; Cohen’s d ranges 0.39-0.99); differences in TST were non-significant at all timepoints (all p&gt;.25). The RB condition had significantly longer TST at T4 (40.10 min longer, p=.008, d=.63) compared to CTRL, but these two conditions did not differ significantly on any other measures across all timepoints (p&gt;.22).

Conclusion
Preliminary findings suggest CBT-I was efficacious in preventing insomnia symptoms and reducing sleep disturbance and sleep-related impairment, but did not increase maternal sleep duration postpartum. Conversely, a responsive bassinet designed to support infant sleep meaningfully increased maternal sleep duration at 6 months postpartum but did not prevent insomnia symptoms. These initial findings suggest that perinatal sleep complaints are a multifactorial problem that likely require multi-component interventions targeting different causes and mechanisms.

Support (If Any)
National Health and Medical Research Council, Department of Education and Training.
0479 Prescribing Patterns for Hypnotic Medication Among Adults Seeking CBTI Treatment: A Preliminary Report from the RESTING Study
Authors: Simpson Norah , Kim Jane , Tully Isabelle , Dietch Jessee , Tutek Joshua , Gumport Niki , Palaniappan Latha , Rosas Lisa , Zulman Donna , Manber Rachel 
Published: May 2022

Abstract

Introduction
Use of prescription hypnotic medications is common among adults with chronic insomnia; however, little is known about prescribing patterns for hypnotic medication in middle-to-older age adults with insomnia disorder who seek to engage in cognitive behavioral therapy for insomnia (CBTI).

Methods
Participants were 235 adults aged 50 or older with insomnia disorder (mean age 63.1y [SD 7.7y], 73.6% women) enrolled in the ongoing Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING). At screening, participants provided information about prescribed medications for sleep, insomnia severity (Insomnia Severity Index), daytime sleepiness (Epworth Sleepiness Scale), chronotype (Composite Morningness Questionnaire), depression (Geriatric Depression Scale) and physical and mental health (PROMIS Global-10, Physical and Mental Health Subscales).

Results
Of the 235 participants, 95 (40.4%) reported taking at least one medication prescribed to improve sleep. 26.5% were prescribed multiple medications (polypharmacy). Non-benzodiazepine receptor agonists (non-BzRAs) were the most common (prescribed to 51.6% of medication-using sample), followed by benzodiazepines (Bzs; 35.8%) and trazodone (20.0%). 25.2% of participants took a variety of other prescription medications at lower frequencies.Comparing patient characteristics for patients prescribed non-BzRAs, Bzs, and trazodone monotherapies, as well as polypharmacy, there were no significant differences in age, gender, insomnia severity or any other clinical characteristics, outside of modest associations within the PROMIS physical health scale (F[3,81]=2.78, p=.046); participants prescribed trazodone as monotherapy had significantly higher scores (better physical functioning) than participants prescribed non-BzRAs. Bzs were more likely to be prescribed as part of polypharmacy (52.9% of patients prescribed Bz) in the total medication using sample compared to those taking non-BzRAs (34.7%) or trazodone (36.8%; p&lt;.001).

Conclusion
In this study, a high percentage of adults with insomnia seeking CBTI were also taking medications prescribed for sleep, including medications that are associated with increased risk (benzodiazepines, polypharmacy) or are not FDA-approved for insomnia (trazodone). Increasing prescriber knowledge about CBTI may promote adherence to the American Geriatric Society Beers Criteria for potentially inappropriate medication use in older adults. More research on how prescription patterns may differ among provider specialties could help target educational efforts to increase utilization of CBTI.

Support (If Any)
1R01AG057500
0480 Reduction in health care-related costs after initiation of treatment with a prescription digital therapeutic for chronic insomnia: two-year follow up analysis of health care claims data
Authors: Forma Felicia , Knight Tyler , Thorndike Francis , Xiong Ray , Baik Rebecca , Maricich Yuri , Velez Fulton , Malone Daniel 
Published: May 2022

Abstract

Introduction
The objective of this study was to evaluate the effectiveness of the first FDA-authorized prescription digital therapeutic (PDT) for adults with chronic insomnia that delivers evidence-based treatment (Somryst, previously called SHUTi). FDA considers PDTs to be prescription-only neurobehavioral devices that provide a computerized version of condition-specific behavioral therapy as an adjunct to clinician supervised outpatient treatment.

Methods
A pre/post multi-payer analysis of claims data was conducted, comparing two-year pre- and post-index healthcare resource utilization (HCRU) in an all-comer population of patients with self-identified sleep problems across the United States who activated the PDT between February 1, 2012 and December 31, 2018 (Index). HCRU categories assessed were: hospitalizations, treat-and-release emergency department (ED) visits, ambulatory surgical center (ASC) visits, hospital outpatient department (HOPD) visits, office visits, number of sleep medication prescriptions, and associated health care costs. Costs were estimated by multiplying HCRU by published average costs for each medical resource.

Results
252 patients initiating the PDT were analyzed (mean age 54.2 years, 57.5% female). Compared to the pre-index period, post-index events were reduced for ED (-56.2%; P=0.001), hospitalizations (-20.9%; P=0.4), sleep medication use (-8.9%; P=0. 0.377), HOPD (-8.3%; P=0.522), and ASC (-6.7%; P=0.695). Post-index events were slightly increased for office visits (+0.7%; P=0.891). Total estimated two-year cost savings associated with the reduced rates of all services except office visits was $494,634, or $1,963 per patient.

Conclusion
In a real-world cohort of patients with self-identified sleep problems, treatment with a PDT delivering digital CBT-I was associated with clinically meaningful net reductions in health-related services and associated costs.

Support (If Any)
This analysis was funded by Pear Therapeutics, Inc.
0484 Trouble Sleeping Predicts Future Decreased Quality of Life in Young Children with Fontan Circulation
Authors: Combs Daniel , Partha Meghana , Hsu Chiu-Hsieh , Edgin Jamie , Seckeler Michael , Klewer Scott , Parthasarathy Sairam , Cooper David 
Published: May 2022

Abstract

Introduction
Children with congenital heart disease who undergo a Fontan procedure are at higher risk of reduced health-related quality of life (HR-QOL) compared to age-matched peers. We have previously shown that current sleep disturbances are associated with decreased HR-QOL, but there is no existing longitudinal data on the relationship between sleep disturbance and HR-QOL in children with Fontan circulation.

Methods
We analyzed data from the Pediatric Heart Network Single Ventricle Reconstruction follow up study to evaluate associations between parent-reported trouble sleeping with HR-QOL as measured by the child health questionnaire (CHQ, measured at age 6 years) as well as the Pediatric Quality of Life questionnaire (PedsQL, measured at baseline as well as age 4, 5 and 6 years) in children with Fontan circulation. Presence of trouble sleeping was assessed at baseline and quality of life was assessed at baseline (age 3 years old) and annually for 3 years. Analysis was performed using the Wilcoxon sum rank test.

Results
227 participants had data at baseline (age 3 years), and 196 participants completed HR-QOL measures at all time points. Parent-reported trouble sleeping was reported “often” or “almost always” in 11% of participants. Baseline trouble sleeping predicted decreased HR-QOL at all future time points, particularly psychosocial HR-QOL. Psychosocial HR-QOL as measured by the Peds QL was significantly lower at all time points in the group with trouble sleeping. At age 6 years, psychosocial HR-QOL remained significantly lower in the group with trouble sleeping at baseline on both the PedsQL (median score 78 [interquartile range 63, 90] vs 65 [58, 83], p=0.03) and the CHQ (median t-score 54 [47, 59] vs 47 [42, 53], p=0.002).

Conclusion
Trouble sleeping in children with Fontan circulation predicts future decreased HR-QOL. Better understanding of sleep problems is needed in children with Fontan circulation as sleep disorder treatment may lead to improved HR-QOL in this at-risk population.

Support (If Any)
Funding to DC from the American Heart Association and NIH-NHLBI. Single Ventricle Reconstruction study data obtained from the Pediatric Heart Network.
0487 Exploration of Sleep Problems and Medication Use for Youth Residing in Juvenile Justice Facilities
Authors: McGee Ryann , Foster Mea , Adornetti Julianna , Leask Lauren , Bayley Shania , Nogales Josephina Munoz , Woodard Kelsey , Carlucci Marianna , Crowley Stephanie , Wolfson Amy 
Published: May 2022

Abstract

Introduction
Insufficient and disordered sleep are common among developing adolescents and can result in poor health and behavioral consequences. Previous studies have examined sleep and adolescent criminal behavior; however, little is known about adolescent sleep difficulties or disorders while residing in juvenile detention and treatment facilities. The current study explores psychiatric and sleep disorder diagnoses and medication use of youth under the care of the Department of Juvenile Services (DJS).

Methods
Participants were recruited from 11 detention and treatment facilities across Maryland. Youth (N = 67) were 13-19 years old (M = 16.8, SD = 1.2) and 84% male and 16% female. Racial Backgrounds: 55% Black, 18% White, 14% Multiracial, and 12% Other. A Healthcare staff member from each facility completed an online medical questionnaire regarding each youth’s sleep history, medical diagnoses, and current medications.

Results
The most common youth diagnoses were Insomnia (N = 26), ADHD (N = 26), and Anxiety (N = 12) with 72% of youth having more than one psychiatric/sleep disorder diagnosis. The most frequently used medications were melatonin (N = 23), trazodone (N = 12), and quetiapine (N=7) and 58% were on more than one sleep/psychotropic medication. Healthcare staff ordered 25 behavioral sleep studies (e.g., DJS behavioral sleep studies consists of night resident staff tracking if youth is asleep/awake while making rounds), resulting in diagnoses of insomnia (N=9) and parasomnia (N=1). Youth with sleep studies were prescribed the following medications: trazodone (N = 5), melatonin (N = 3), other (e.g., methylphenidate, clonidine, N = 11).

Conclusion
These preliminary findings suggest that youth are experiencing poor sleep quality while residing in juvenile justice facilities; over a third of the youth are struggling with insomnia and are prescribed Melatonin. Further data analyses will provide a better understanding of the youths’ sleep problems and the effects on their overall health and well-being.

Support (If Any)
This research is made possible by the American Academy of Sleep Medicine (AASM) Foundation Award #22-CS-19 and Department of Juvenile Services’ supportive collaboration.