bluuebunny/crossref_metadata_2025_split huggingface dataset:
0504 Efficacy and Safety of Seltorexant in Insomnia Disorder
Authors: Savitz A , Saoud J B 
Published: May 2020

Abstract

Introduction
Insomnia disorder affects 3-6% of the population and includes functional impairing symptoms for ≥3 months. Current hypnotics have limitations (eg fall risk, dependency, parasomnia, cognitive impairment). In a previous proof-of-concept study, seltorexant, a selective orexin-2 receptor antagonist, dosed at 40mg nightly improved sleep efficiency, latency to persistent sleep (LPS), and wake after sleep onset (WASO) versus placebo.

Methods
A multicenter, double-blind, randomized, parallel-group, active- and placebo-controlled, 14-day, dose-finding study (NCT03375203) assessed the efficacy and safety of seltorexant in adult and elderly subjects meeting DSM-5 insomnia disorder criteria. Subjects were randomized (1:1:1:1:1 ratio) to: placebo, seltorexant 5mg, 10mg, 20mg, or zolpidem. Primary endpoint: Based on PSG, dose response in LPS change on Night 1 relative to baseline. Secondary endpoints included change from baseline in: WASO over the first 6 hours (WASO-6) on Night 1, and LPS and WASO-6 on Night 13. Multiple Comparison Procedure-Modeling, ANCOVA and MMRM were used for data analyses.

Results
365 patients were randomized and 347 (95%) completed the double-blind phase with 68% women and median age of 59yr (22 to 84yr). Statistically significant dose-response relationship (p-value &lt;0.001) was observed for LPS at Night 1 (5mg=12%, 10mg=36%, 20mg=49% improvement compared with placebo). Similar findings were observed for WASO-6 and benefits sustained from Night 1 to 13. The 20 mg dose showed greater improvement than zolpidem on LPS at Nights 1 and 13 and on WASO-6 at Night 13. Overall treatment-emergent adverse events rates were comparable in the seltorexant, placebo, and zolpidem treatment groups.

Conclusion
Statistically significant and clinically meaningful improvements on LPS & WASO-6 were observed for seltorexant 10 and 20mg dose groups versus placebo. No safety concerns were observed. Seltorexant with its novel mechanism holds potential as a new treatment for insomnia disorder.

Support
0513 Comparison of Patient Satisfaction and Therapeutic Alliance for Telemedicine vs. Face-to-Face Delivered Cognitive Behavioral Therapy for Insomnia
Authors: Conroy D A , Mooney A , Pace D , Balstad S , Dubuc K , Yang A , Furgal A , Sen A , Arnedt J 
Published: May 2020

Abstract

Introduction
CBT for insomnia (CBTI) is effective but a barrier to its widespread use is the lack of evidence-based delivery modalities other than face-to-face. The perception and acceptability of telemedicine for the delivery of CBTI is unknown. We conducted a randomized controlled non-inferiority trial comparing face-to-face (F2F) and telemedicine (via AASM SleepTM) delivery of CBTI. We compared measures of patient satisfaction with treatment and the perception of the therapist’s warmth and skills between F2F and SleepTM.

Methods
Adults with insomnia were recruited from insomnia clinics and the community and screened for sleep, medical, and mental health disorders. Eligible participants were randomized to receive CBTI either via AASM SleepTM or F2F in 6 weekly sessions of 45-60 minutes each. Participants completed the Client Satisfaction Questionnaire (CSQ-8) and The Therapy Evaluation Questionnaire (TEQ) after completing treatment. The CSQ-8 score ranges from 8-32 with high scores indicating greater satisfaction. We also analyzed the two items on the TEQ that assess participants’ perception of therapist’s warmth and skills. Item scores ranged from 1-7, with higher scores indicating greater warmth and skills.

Results
Sixty-five adults with chronic insomnia were recruited primarily from insomnia clinics. Sixty-two participants (41 women, mean age 48.9 ± 15.4 years) completed all 6 sessions of CBTI via F2F (n=32) or via AASM SleepTM (n=30). Independent samples t-tests revealed no significant differences between conditions on patient satisfaction (SleepTM, 28.5 +/-4.2 vs F2F 29.9 +/-2.4, t(-1.5), p=.14), therapist warmth (SleepTM, 6.0 ±1.1 vs F2F, 6.4±0.95, t(-1.4), p=.16), or therapist skills (Sleep TM 6.4 ±1.0 vs F2F, 6.7±0.59, t(-1.5), p=.15).

Conclusion
Our findings suggest no differences in patient satisfaction, perception of therapist’s warmth, or confidence in therapist’s skills between telemedicine (via the AASM SleepTM) and F2F delivery of CBTI. Telemedicine-delivered CBTI should be implemented more widely.

Support
Research supported by American Sleep Medicine Foundation Grant # 168-SR-17 (JT Arnedt)
0519 Mindfulness Based Therapy for Insomnia Improves Objective Markers of Sleep in the Elderly: Preliminary Data from the Mindfulness Sleep Therapy (MIST) Study
Authors: Wong K F , Perini F , Henderson S L , Teng J , Hassirim Z , Lin J , Leow Z , Fan Q , Ong J , Lo J , Ong J C , Doshi K , Lim J 
Published: May 2020

Abstract

Introduction
Mindfulness-based treatment for insomnia (MBTI) is a viable intervention for improving poor sleep. We report preliminary data from an ongoing pre-registered, randomized controlled trial which investigates the effect of MBTI on elderly adults.

Methods
Participants above 50 years old with PSQI ≥ 5 were recruited and randomised into either MBTI or an active control group (Sleep hygiene education and exercise program, SHEEP) in sequential cohorts with about 20 participants per cohort (10 per group). Before and after the intervention, 1 night of portable polysomnography (PSG) and 1 week of actigraphy (ACT) and sleep diary (DIARY) data were collected. We report the ACT and DIARY results of the first 3 cohorts (n = 46, male = 23, mean age = 62.3, std = 6.3) and PSG data of the first 2 cohorts (n = 29, male = 12, mean age = 62.5, std = 5.7). Time in bed (TIB), total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were analysed with mixed-model repeated-measures ANOVA.

Results
We observed increases in TIBDIARY (F1,44 = 5.151, p &lt; .05) and SEDIARY (F1,44 = 22.633, p &lt; .0001), and significant reductions in SOLDIARY (F1,44 = 7.031, p &lt; .05) and WASODIARY (F1,39 = 7.411, p &lt; .05). In the actigraphy data, we found a significant interaction in SOLACT (F1,39 = 4.273, p &lt; .05) with an increase in SHEEP SOLACT (t18= 2.36, p &lt; .05). Significant reductions were also observed in WASOACT (F1,44 = 16.459, p &lt; .0001) Finally, we observed a reduction in SOLPSG (F1,26 = 5.037, p &lt;. 05). All other tests were non-significant.

Conclusion
Preliminary results suggest that both interventions lead to improvements in sleep with more pronounced effects in subjective sleep reports. Objective sleep data suggest that improvements in sleep is a result of improved sleep quality and not simply extending sleep opportunity. These preliminary data shows that MBTI may be a promising intervention for elderly individuals with sleep difficulties.

Support
This study was supported by an award from the 7th grant call of the Singapore Millennium Foundation Research Grant Programme
0523 A Pilot, Placebo-controlled Trial of Closed-Loop, Artificial Intelligence Driven, Acoustic Neuromodulation for Insomnia
Authors: Tegeler C H , Tegeler C L , Howard L J , Brown K L , Kellar D C , Gerdes L , Shaltout H A 
Published: May 2020

Abstract

Introduction
In prior studies, High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) reduced symptoms of insomnia, and improved heart rate variability (HRV), but is operator dependent, and difficult to scale. Cereset Research™ (CR), is a noninvasive, closed-loop, artificial intelligence (AI) driven, acoustic neuromodulation technology. CR uses the same core technology, echoing tones linked to brainwaves, but includes updated components, standardized AI driven protocols, software management of designs, and shorter sessions to improve scalability. This controlled trial explores use of CR for insomnia.

Methods
Adults with insomnia (Insomnia Severity Index, ISI, of ≥8 points for ≥1 month) receive ten 60 minute sessions of tones linked to brainwaves (CR), versus random tones (RT). Data is collected at baseline (V1), 0-14 days (V2), and 6-8 weeks (V3) after intervention. Primary outcome is change in ISI at V3. Secondary outcomes include HRV (SDNN and rMSSD) based on 10-minute BP and HR recordings using a BIOPAC device. RT subjects can cross-over to CR after V3. Formal analysis of insomnia outcome awaits the target of n = 20 to complete intervention, but we report preliminary changes in ISI, and secondary outcomes, SDNN and rMSSD.

Results
21 subjects have enrolled (15 women), with one dropout after first session and one after 6th session due to job changes. For n = 17, change in median ISI score from V1 to V3 is -7 for CR, and -4 for RT. Mean SDNN increased 32.2% (SE 12.8) for CR, and 5.6% (14.7) for RT, while rMSSD increased 88.8% (36.7) for CR, and 33.7% (38.7) for RT, with no serious adverse events reported.

Conclusion
Preliminary results suggest similar, clinically meaningful reductions in ISI score, and increased HRV with CR, as seen with HIRREM, suggesting promise as a scalable, non-drug intervention for insomnia with accompanying impact on autonomic function. Final results will be presented.

Support
Research grant from, The Susanne Marcus Collins Foundation, Inc.
0530 Hybrid Cognitive Behavior Therapy for Insomnia (CBT-I) and Acceptance and Commitment Therapy (ACT) Group Treatment Model for Insomnia and Chronic Pain
Authors: Ochsner Margolies S 
Published: May 2020

Abstract

Introduction
Insomnia is a common complaint for individuals with chronic pain. CBT-I as an intervention for these patients shows strong improvement in sleep but not consistently in pain outcomes. Current treatment approaches for chronic pain focus increasingly on acceptance-based interventions. Integrating ACT into a CBT-I group protocol has the potential to optimize both sleep and pain outcomes.

Methods
A hybrid CBT-I/ACT 6-session weekly group protocol for chronic pain and insomnia was developed and piloted. CBT-I components included sleep education, stimulus control, and sleep restriction. ACT components included cognitive defusion, self-as-context, present moment awareness, mindfulness, and values-guided behavioral activation. Pre-post measures assessing insomnia symptoms, sleep parameters based on sleep diary, sleep catastrophizing, pain catastrophizing, pain acceptance, beliefs about pain and sleep, depression, and anxiety were analyzed using frequency analyses and paired sample t-tests.

Results
Group participants (4) recruited from an outpatient pain management clinic were on average 57 years old, 100% female and 75% White. Post-treatment, patients reported significantly improved insomnia symptoms (ISI Mdiff=5.8, SDdiff=3.9, p &lt; .05, ES=1.5), sleep efficiency (SE, Mdiff=16%, SDdiff= 10%, p = .05, ES=1.5), pain catastrophizing (PCS Mdiff=7.8, SDdiff=4.6, p &lt; .05, ES=1.6), pain acceptance (CPAQ Mdiff=11.5, SDdiff=7.5, p = .05, ES=1.5), beliefs about the relationship between pain and sleep (PBAS Mdiff=2.3, SDdiff=1.3, p &lt; .05, ES=1.8) and anxiety (GAD-7 Mdiff=3.3, SDdiff=2.1, p &lt; .05, ES = 1.6).

Conclusion
Hybrid CBT-I/ACT group protocol for chronic pain and insomnia showed significant improvements in sleep and, more importantly, pain outcomes. This pilot study demonstrates the benefits of incorporating an ACT approach to optimize pain as well as sleep outcomes. Future efforts will continue to refine the CBT-I/ACT protocol in anticipation of conducting a dismantling study to determine the clinical benefits of adding an ACT framework to the CBT-I model.

Support
NA
0531 Efficacy of a Single 4 Hour CBT-I Workshop in a Community Sample with Self-Reported Insomnia Symptoms
Authors: Okun M , Glidewell R 
Published: May 2020

Abstract

Introduction
Cognitive behavioral treatment for insomnia (CBT-I) is the first line of treatment for insomnia. However, experts have noted that the expanded use of CBT-I is limited by the small number of specialty-trained clinicians, as well as the duration and cost of individual treatment sessions (usually 6-8). One solution is a single-session educational group format delivered by a trained health educator rather than a licensed clinician. Our objective was to evaluate the efficacy of group CBT-I delivered by a Ph.D. level health educator to community dwelling individuals with self-reported insomnia symptoms.

Methods
Participants were referred from clinicians, our website, and social media postings. Participants completed the Insomnia Severity Index, provided information on type of sleep aid use and frequency, and the presence of co-morbid conditions prior to and 1-month post attendance of a single 4-hour CBT-I workshop.

Results
Participants (N = 31) were 58 ± 12 years of age (range 29 - 80); 11 Males, 20 Females; 90.6% white; 66% married; 71.8% at least a college graduate; and 34.3% had an average income of &gt; $100K. Comorbidities included pulmonary disease (6%), GI disease (9.6%), endocrine disease (9.6%), and headaches (25.8%). Insomnia Severity Index scores significantly improved from baseline (19.6 ± 5.06) to 1-month (FU 13.7 ± 6.33) (t = 21.9, P &lt; .001)). Similarly, frequency of sleep aid use significantly dropped (χ 2 = 105.7, p = .017). Subjective improvement in sleep was reported as the following: 12.5% much better, 56.3% better, 25% the same, and .03% worse.

Conclusion
These data indicate that a single 4-hour CBT-I workshop delivered by a health educator can significantly reduce insomnia symptoms, improve subjective sleep quality, and reduce sleep aid use among community dwelling adults with self-reported insomnia symptoms within 1-month. These data extend what has been shown primarily in older adults. That is, brief behavioral treatment for insomnia can be acceptable and efficacious to anyone reporting insomnia symptoms.

Support
The Insomnia Clinic
0557 Possible Contributory and Protective Factors in Medication Associated Obstructive Sleep Apnea (OSA): Results from the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS)
Authors: Gupta M A , Vujcic B 
Published: May 2020

Abstract

Introduction
There are conflicting opinions regarding the role of medications in OSA. A Vigibase (WHO pharmacovigilance database) study (Linselle M, 2017) has suggested several drug groups in OSA pathogenesis. Sodium oxybate, benzodiazepines and opioids are most consistently associated with OSA. We examined the adverse drug reaction (ADR) of OSA with the ‘primary suspect’ drugs for the ADR, in the US Food and Drug Administration Adverse Events Reporting System (FAERS) database.

Methods
The FAERS database from January 1, 2004-March 31, 2019 (total ISR =12,330,939) was examined for Individual Safety Reports (ISR) with OSA as ADR and associated ‘primary suspect (PS)’ medications. Reporting odds ratios (ROR) were calculated to assess disproportionality signals with the ‘PS’ drug and OSA versus the ‘PS’ drug associated with all other ADRs in the database.

Results
15,316 ISR were associated with OSA [mean±SD age: 49.21 ± 21.76 years (based on 10,311 ISR); 53.78% female (based on 12,274 ISR]. Increased disproportionality signals for OSA were detected with some of the following ‘PS’ drugs/drug groups: sodium oxybate [ROR=31.75, (95% CI 30.36-33.20)]; rofecoxib [ROR=7.85 (95% CI 7.40-8.32)], alendronate [ROR=3.60 (95% CI 3.37-3.84)], zoledronic acid [ROR=24.70 (95% CI 21.88-27.89)], omalizumab [ROR=2.36 (95% CI 2.09-2.68)], quetiapine [ROR=3.78 (95% CI 3.32-4.30), finasteride [ROR=6.03 (95% CI 5.17-7.04), pregabalin [ROR=1.19 (95% CI 1.01-1.41), isotretinoin [ROR=1.49 (95% CI 1.23-1.80)], ondansetron [ROR=3.35 (95% CI 2.77-4.06), olanzapine [ROR=2.64 (95% CI 2.17-3.20), sitagliptin [ROR=3.46 (95% CI 2.82-4.24, digoxin [ROR=2.83 (95% CI 2.24-3.57), benzodiazepines [ROR=1.80 (95% CI 1.33-2.42), and opioids [ROR=1.34 (95% CI 1.09-1.67)]. A decreased disproportionality signal was detected with several biologics including: adalimumab [ROR=0.87 (95% CI 0.79-0.95)], etanercept [ROR=0.55 (95% CI 0.49-0.61)], and infliximab [ROR=0.51 (9% CI 0.40-0.65)].

Conclusion
The FAERS data supports many of the earlier findings suggesting the heterogeneity of medications associated with OSA. Biologics (mainly TNF-alpha antagonists) were associated with the previously unreported finding of a decreased OSA risk.

Support
None.
0600 Automated Oximetric Versus Standard Sleep Polygraphy Scoring
Authors: Skjodt N M , Pahwa V , Platt R S 
Published: May 2020

Abstract

Introduction
Agreement between automated standard respiratory event scoring and a novel, validated, and patented oximetry-based algorithm was assessed.

Methods
The standard apnea-hypopnea index (AHI) was derived by adding apneas (flow drop &gt;= 90% for 10 to 30 s) and hypopneas (flow drop &gt;= 30% for 10 to 60 s with oxygen saturation (SpO2) dropping &gt;=3%). The novel oxygen index (ODI4) was derived by scoring events where SpO2 dropped in each of three successive samples and cumulatively by &gt;= 4%. Agreement was assessed by Bland-Altman analysis

Results
AHI versus ODI4 and Bland-Altman plots showed a high prevalence of AHI &gt; ODI4 when AHI was&lt; 30/h. Negative difference outliers were frequent when mean index difference was &gt; 30/h. There was a bias of 2.83/h in the difference between AHI and ODI4 with upper and lower confidence limits of 22.0/h and -16.3/h.

Conclusion
Standard respiratory event scoring overestimates respiratory disturbance compared to a novel oximetric index. Standard automated scoring frequently over scores events when basal flow amplitude is low.

Support
None.
0601 Use of The Epworth Sleepiness Scale, the NoSAS, and the STOP-BANG Questionnaire to Identify Patients with Moderate-to-Severe Obstructive Sleep Apnea
Authors: Yin S , Xu H , Zhang C , Zou J , Guan J , Yi H 
Published: May 2020

Abstract

Introduction
A variety of scales and questionnaires regarding sleep and sleep-related disorders have been widely used in scientific research and clinical practice, as important tools for differential diagnosis and rapid screening of complex sleep disorders, especially obstructive sleep apnea (OSA). However, the diagnostic efficacy of different scales and questionnaires for patients with different severity of OSA and of different demographic characteristics has not been clearly described. In this study, we evaluated the ability of the most popular scales, including the Epworth Sleepiness Scale (ESS), the NoSAS, and the STOP-BANG questionnaire in predicting moderate-to-severe obstructive sleep apnea (OSA) by gender.

Methods
This cross-sectional study screened 2,031 consecutive subjects referred with suspected OSA from 2012 to 2016. Anthropometric measurements, polysomnographic data, ESS, NoSAS scores and STOP-BANG scores were recorded. Receiver operating characteristic curve analyses were performed, and the final predictive models were verified in a validation cohort.

Results
A total of 1,840 adults were finally included. The STOP-BANG questionnaire afforded a better diagnostic accuracy than did the ESS, with different cutoffs for the two genders: 3 in males and 1 in females. A predictive model based on STOP-BANG yielded an area under the curve (AUC) of 0.918 (0.897-0.935), a sensitivity of 79.89%, and a specificity of 89.19%, in males; and an AUC of 0.951 (0.914-0.975), a sensitivity of 80.52%, and a specificity of 95.92%, in females. In the validation cohort, the sensitivity and specificity were respectively 85.44 and 93.00% in males and respectively 83.02 and 87.60% in females.

Conclusion
The STOP-BANG questionnaire was moderately effective when used to screen for moderate-to-severe OSA. A STOP-BANG-based predictive model afforded excellent diagnostic efficacy, which could be applied in clinical practice. However, gender differences must be considered.

Support
This study was supported by Grants-in-aid from Shanghai Municipal Commission of Science and Technology (Grant No.18DZ2260200).
0609 Sleep Phenotypes in Middle-Aged and Older Hispanics/Latinos. Results from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL)
Authors: Wu B , Tarraf W , Wallace D M , Stickel A , Schneiderman N , Redline S , Patel S R , Gallo L C , Mossavar-Rahmani Y , Daviglus M , Zee P C , Talavera G A , Sotres-Alvarez D , Gonzalez H M , Ramos A R 
Published: May 2020

Abstract

Introduction
Identifying sleep phenotypes in the diverse and understudied US Hispanic/Latino population is critical to developing interventions and mitigating distal clinical outcomes (e.g. dementias).

Methods
Using latent class analyses (LCA), we identify empirically derived and clinically meaningful sleep phenotypes using data on community dwelling middle-aged/older adults (ages ≥45-years) from the HCHS/SOL (2008-2011) - Investigation of Neurocognitive Aging (n=6,377). Sleep variables used included Apnea/Hypopnea Index (AHI), percent time SpO2&lt;90%, Epworth Sleepiness Scale (ESS), Women’s Health Initiative Insomnia Rating Scale (WHIIRS), self-reported average sleep duration, restless legs symptoms, napping frequency, and sleep quality.

Results
Mean (M) age was 56.4±8.1 years, and 54.7% were female. Average AHI, ESS, WHIIRS, and sleep duration were 8.7±13.1, 6.0±5.0, 7.6±5.5, and 7.8±1.4, respectively, and 25.8% had zero percent time SpO2 &lt;90%. Fit statistics indicated that a four-class solution provided the best data fit. The derived classes, adjusting for age, sex, income, and acculturation, corresponded with four clinically meaningful groups: (1) 28.8% were asymptomatic [(M) AHI=0.8; (M) ESS=5.6; (M)WHIIRS=7.6; (M) sleep duration=7.8; 0% SpO2&lt;90%=74.1%], (2) 25.7 % were asymptomatic mild sleep apnea [(M) AHI=6.2; (M) ESS=3.8; (M) WHIIRS=2.9; (M) sleep duration=7.8; 0% SpO2&lt;90%=8.8%], (3) 19.4% were symptomatic sleep apnea [(M) AHI=25.6; (M) ESS=8.5; (M) WHIIRS=7.2; (M) sleep duration=7.7; 0% SpO2&lt;90%= 0.5%], and (4) 26.1% were insomnia [(M) AHI=5.7; (M) ESS=6.7; (M) WHIIRS=13.0; (M) sleep duration=7.8; 0% SpO2&lt;90%=10.3%]. Classification into groups 3 and 4 were primarily driven by elevated AHI and WHIIRS scores, respectively. The distribution of scores in the derived groups suggest variations relative to current clinical thresholds.

Conclusion
We identified 4-groups using LCA in a community-based sample of diverse U.S. Hispanic/Latino adults. Better characterization of sleep phenotypes for Hispanics/Latinos can help in developing targeted interventions studies and ameliorate health disparities.

Support
5R01AG048642-05; R21AG056952; R21HL140437.