bluuebunny/crossref_metadata_2025 huggingface dataset:
0368 Sleep Health Among Transgender Women of Color in New York City: Preliminary Analyses of the Turnnt Study
Authors: Duncan D , Schneider J , Radix A , Harry-Hernandez S , Callander D
Published: May 2020

Introduction

Little is known about sleep health among transgender and gender diverse populations. Even less is known about sleep among transgender women of color, a population that experiences considerable health disparity.

Methods

Interim baseline data were analyzed from the TURNNT (Trying to Understand Relationships, Networks and Neighborhoods among Transgender women of color) Study, an ongoing cohort of 350 HIV-negative transgender women of color in New York City. At baseline, items from the widely-used Pittsburgh Sleep Quality Index (PSQI) were used to measure typical sleep duration and subjective sleep quality. For example, typical sleep duration was measured with the PSQI item, “During the past month, how many hours of actual sleep did you get each night?”. Participant responses were analyzed descriptively; the Mann-Whitney U test was used to assess bivariate associations.

Results

As of November 2019, there were n=31 participants enrolled in TURNNT. Nearly half of participants earned less than $30,000 per year (48%) and in the 6 months before participation 61% had experienced food insecurity and 13% reported being unstably housed. Participants reported typically receiving 2-12 hours of sleep per night (median=6 hours). With short sleep defined as <7 hours per night, 55% reported this during the month prior to participation in the study, while 29% of participants rated their overall sleep quality as poor. Typical sleep duration was equivalent among participants with lower or higher incomes (5.5 vs 7 hours, p=0.3), but those who faced food insecurity reported less sleep (5 vs 7 hours, p<0.05) as did those who experienced housing instability (3.5 vs 7 hours, p<0.05).

Conclusion

Poor sleep health was common among our sample of transgender women of color, especially among those experiencing food insecurity and housing instability. Future research should examine multi-level correlates of poor sleep health such as network structures and neighborhood environments.

Support

The TURNNT (Trying to Understand Relationships, Networks and Neighborhoods among Transgender women of color) Study is funded through grants from the National Institute on Minority Health and Health Disparities (Grant Numbers: R01MD013554 and 3R01MD013554-02S1; Principal Investigator: Dustin T. Duncan, ScD).
0372 Disparities in Sleep Timing in the US: Data From the National Health and Nutrition Examination Survey 2015-2016
Authors: Mota Villalobos K , Seixas A A , Williams N J , Jean-Louis G , Killgore W D , Wills C C , Grandner M A
Published: May 2020

Introduction

Several studies have demonstrated population-level disparities in sleep duration and sleep quality. Population-level estimates of bedtime and waketime have been unavailable. Considering the important role of circadian rhythms in health, population-level disparities in timing have important public health implications.

Methods

Data from the 2015-2016 National Health and Nutrition Examination Survey (NHANES) from the CDC were used (N=4,491). Typical time in and out of bed were assessed and were converted to minutes. Race/ethnicity was self-reported and coded as non-Hispanic White, Black/African-American, Mexican-American, Other Hispanic/Latino, Asian, and Multiracial/Other. Covariates included age, sex, education level, income/poverty ratio, body mass index, and overall health. Additional models controlled for habitual sleep duration, frequency of sleep disturbance, depressed mood, and daytime tiredness/fatigue. Multiple linear regression analyses with time as an outcome were weighted using CDC-provided NHANES sample weights.

Results

In adjusted analyses, compared to non-Hispanic Whites, Blacks/African-Americans went to bed 29.4 mins later (p<0.0005), Asians went to bed 37.0 mins later (p<0.0005) and woke 27.7 mins later (p<0.0005), and Mexican-Americans woke 16.3 mins earlier (p=0.018). After further adjustment for sleep duration and sleep disturbances, Blacks/African-Americans went to bed 22.1 mins later (p<0.0005) and woke 22.2 mins later (p<0.0005), and Asians went to bed 36.1 mins later (p<0.0005) and woke 40.6 mins later (p<0.0005). These relationships remained generally unchanged when depressed mood and daytime tiredness/fatigue were adjusted in the model.

Conclusion

This is the first nationally-representative study to demonstrate population-level disparities in sleep timing. Specifically, Blacks/African-Americans and Asians present with delayed sleep, even after adjusting for other aspects of sleep.

Support

Dr. Grandner is supported by R01MD011600
0380 Association of Day-to-Day Variability in Rest-Activity Circadian Rhythm with Sleep Quality Among Law Enforcement Officers
Authors: Fekedulegn D , Service S , Ma C , Gu J , Violanti J , Andrew M
Published: May 2020

Introduction

Poor sleep quality may be attributed to several occupational factors and has been linked to adverse health outcomes, including cardiovascular disease. Recent epidemiologic studies suggest rest-activity circadian rhythm (RAR) as a possible determinant of poor sleep quality. The focus of these studies has been on the magnitude of the parameters of RAR with little attention to the impact of their day-to-day fluctuation. We examined association of daily variation in parameters of RAR with sleep quality.

Methods

Participants (n=280) were officers from the Buffalo Cardio-metabolic Occupational Police Stress Study (2004-2009). Sleep quality was determined using the Pittsburgh Sleep Quality Index (PSQI). Participants wore wrist actigraph for a minimum of seven days. A cosine curve was fit to measure goodness of fit and estimate the mean values of the three parameters of RAR: Mesor, Amplitude, and Acrophase. Day-to-day variability of the parameters were assessed by fitting the cosine function separately for each day and computing the sample standard deviation across the days. Poisson regression models were conducted adjusting for demographic, lifestyle, and occupational factors.

Results

The prevalence of poor sleep quality was 50.3%. Poor sleep quality was 56% higher in officers with the largest day-to-day variability in Mesor (PR=1.56, 95%CI:1.11 - 2.19) compared to those with the lowest daily variation. Similar estimates were found for Amplitude (PR=1.42, 1.03 - 1.95), Acrophase (PR=1.86, 1.29 - 2.67), and measure of goodness of fit (PR=1.54, 1.13 - 2.11). On the other hand, mean values of RAR parameters were not significantly associated with poor sleep quality.

Conclusion

Results suggest larger daily variation in parameters of RAR is associated with a decrease in sleep quality. Given that day-to-day variation in RAR may increase the odds of poor sleep quality, future studies ought to address risk factors for higher daily fluctuations in RAR which could aid in developing intervention measures.

Support

CDC/NIOSH grant 1R01OH009640-01A1
0411 Association Between Healthy Dietary Patterns and Self-Reported Sleep Disturbances in Older Men
Authors: van Egmond L T , Tan X , Benedict C
Published: May 2020

Introduction

Ageing is often accompanied by an increased prevalence of sleep problems. Healthy lifestyle choices, including diet, are especially important to mitigate such impairments. To date, little is known about how dietary patterns may link to measures of sleep quality in older subjects. Therefore, we investigated in a Swedish older male population, whether adherence to the Mediterranean Diet (MD) or the Healthy Diet Indicator (HDI; based on recommendations from the World Health Organization) is linked to a decrease in sleep disturbances.

Methods

We studied 970 men (age: 71 ± 1yr) from the ULSAM dataset. Sleep initiation or maintenance problems were evaluated by self-reporting questionnaires. Dietary intake was recorded with a pre-coded seven-day food diary. To calculate the adherence scores, intake of dietary components was assessed. Traditional MD components included fat quality, vegetables, fruits, cereals, fish, meat, dairy, and alcohol. The HDI components included saturated-, polyunsaturated fatty acids, proteins, carbohydrates, sucrose, fiber, fruits and vegetables, cholesterol, and fish. Reasonable dietary reporting was calculated to identify possible under- or over-reporters.

Results

When adjusted for potential confounders, no associations between dietary scores and sleep parameters were found. In contrast, low consumption of dairy products —one of the dietary features of the MD —was associated with better subjective sleep initiation. This association was, however, not found in men with adequate reports of daily energy intake (~54% of the cohort).

Conclusion

Our findings do not suggest that older men can mitigate perceived sleep problems by adhering to the MD or HDI. Whether low consumption of dairy products can facilitate sleep initiation must be confirmed in future studies by utilizing objective measures of sleep, such as polysomnography. Finally, when investigating associations between dietary patterns and sleep, particular attention should be paid to the potential confounder of inadequate reporting of energy intake.

Support

This research was funded by Novo Nordisk Foundation (NNF14OC0009349), Swedish Brain Foundation, Swedish Research Council (2015-03100), Åke Wiberg Foundation (M17-0088), Fredrik and Ingrid Thuring Foundation (2017-00313) and the Swedish Medical Research Society.
0450 Screening Method for Obstructive Sleep Apnea Syndrome by Patients’ Exhalant with TD-GC-MS System
Authors: Yao D , Chieng L , Chiang R
Published: May 2020

Introduction

Human exhaled breath test is getting more important for non-invasive health monitoring and detecting method nowadays. The diagnosis of obstructive sleep apnea syndrome (OSAS) is often difficult to be confirmed from the daytime presentation and usually need the overnight polysomnography. The methods for OSAS screening are therefore potentials for the clinical practice in the near future.

Methods

In this research, a method of thermal desorption (TD) tendon with gas chromatography-mass spectrometry (GC-MS) system has been developed for screeing of OSAS patients. We detected the volatile organic compounds (VOCs) from the special designed experimental bags which collected exhaled gas. Then we compared the VOCs from normal control and OSAS group in order to find out the biomarkers which could be used to screen OSAS patients. Furthermore, the Reliable Number(N) was used to see how often the VOC identified in all the experients in OSAS group and was defined as the times of a single VOC identified devided by the times of total experiment in a single OSAS patient.

Results

While the reliable number been set as ≥50%, we found 8 VOC markers, including Pentane and Cyclopentyl acetylene, appeared more often in OSAS patients. When we raise N to ≥70%, we have only 3 markers remaining.

Conclusion

Based on this result, we utilize the artificial intelligence method, deep learning, to figure out whether the peak intensity of different biomarkers are related to the severity of OSAS.

Support

Thanks for Da-Jeng Yao Lab’s support
0476 Readiness and Stages of Change in a Behavioral Sleep Medicine Clinical Sample: From Pre-Contemplation to Struggling to Maintain Change
Authors: Amatrudo G , Puzino K , Bourchtein E , Calhoun S L , Fernandez-Mendoza J
Published: May 2020

Introduction

Stages of change in the transtheoretical model are used to assess a patient’s readiness to change, which may help providers tailor behavioral treatment (BT). As research has focused on substance abuse, there is a significant lack of data in individuals presenting for behavioral sleep medicine (BSM) treatment.

Methods

146 consecutive patients (46.1±16.0 years, 61.6% female, 19.9% minority) who were evaluated at the BSM program of Penn State Hershey Sleep Research & Treatment Center completed the University of Rhode Island Change Assessment Scale (URICA) assessing readiness to change (RtC) and pre-contemplation (P), contemplation (C), preparation/action (A) and struggling to maintain (M) stages of change. Subjects also completed the Insomnia Treatment Acceptability Scale (ITAS) and Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS).

Results

The average RtC score was 9.4, with 21.9% of the sample in stage P, 56.2% in C and 21.9% in A. The average P (53.2±7.6), C (49.1±10.1), A (48.8±12.3) and M (37.7±9.1) scores suggested an overall “contemplation cluster profile”. Higher RtC (r=0.37), C (r=0.31) and A (r=0.24) scores were associated with greater acceptability of BT, while higher P scores were associated with lower acceptability of BT (r=-0.22). In contrast, higher M scores were associated with greater acceptability of pharmacological treatment (r=0.21) as well as higher DBAS scores, including sleep medication expectations (r=0.23).

Conclusion

Patients attending a BSM program typically present at a contemplation stage, which indicates intention to start changing sleep behaviors within the next few months with some ambivalence in regards to pros/cons of such change. A significant proportion of patients struggle to maintain change and present with higher acceptability for pharmacological interventions, which may hinder the effectiveness of BT and may require specific therapeutic approaches.

Support

Department of Psychiatry, Penn State College of Medicine
0477 Characteristics of Insomnia Subjects Screened for Transitioning from Zolpidem Tartrate to Lemborexant in a Multicenter Pilot Study
Authors: Ahmad M , Malhotra M , Amchin J , Kumar D , Perdomo C , Moline M
Published: May 2020

Introduction

Patients who take insomnia medication may change medications for reasons including lack of efficacy, adverse events, and dependence concerns. A pilot study (NCT04009577, E2006-A001-312) assessed a dosing approach for transitioning patients from zolpidem tartrate (ZOL; immediate or extended-release) to lemborexant, a dual orexin receptor antagonist. Here we describe characteristics of subjects who entered the study Screening Period and their reasons for wanting to change medications.

Methods

This multicenter pilot study was conducted in the U.S. and enrolled subjects age ≥18y with insomnia diagnosed per DSM-5 criteria, and who used ZOL (self-reported intermittently [3-4 nights/week] or frequently [≥5 nights/week]) as their only insomnia treatment. Subjects entered a 3-week Screening Period, during which frequency/dose of ZOL taken was recorded; subjects also wore an actigraph continuously. Eligible subjects thereafter entered the Treatment Phase to determine lemborexant dosing (5 or 10mg during a 2-week Titration Period with assignment to 1 of 3 treatment schedules based on ZOL usage frequency during Screening), followed by a 12-week Extension (Maintenance) Phase and a 4-week Follow-up Period.

Results

Forty-nine subjects entered the Screening period and completed the Chief Complaint Form through November 2019; mean(SD) age was 57.1(13.8)y, 67.3% were female, 69.4% were white, and 28.6% were black. 31 subjects reported using ZOL frequently and 15 reported using ZOL intermittently (3 missing). The most common sleep complaint was waking up too early (n=33), followed by difficulty staying asleep (n=13), and difficulty falling asleep (n=3). Reasons for wanting to switch from ZOL included: ZOL not working (n=19), concerns about taking ZOL (n=14), wanting to try something new/potentially better (n=6), side effects (n=5), and residual daytime sleepiness (n=4). 43/49 subjects completed screening through this period.

Conclusion

This study offers the opportunity to understand patients’ current use of insomnia medication and their motivation for wanting to change insomnia medications.

Support

Eisai Inc.
0478 A Multicenter Pilot Study to Evaluate Next-Dose Transition from Zolpidem to Lemborexant for the Treatment of Insomnia
Authors: Rosenberg R , Amchin J , Kumar D , Perdomo C , Moline M , Malhotra M
Published: May 2020

Introduction

Switching of medications for insomnia occurs often in clinical practice based on a variety of reasons. However, few clinical studies have examined methods for transitioning patients between different insomnia medications. This is especially important to consider when the classes of drugs are different (e.g., GABA-ergic agonism vs orexin receptor antagonism); thus, clinical guidance would be valuable. The safety and efficacy of the dual orexin receptor antagonist lemborexant (LEM) for the treatment of insomnia was confirmed in two Phase 3 studies, SUNRISE-1 (NCT02783729, E2006-G000-304) and SUNRISE-2 (NCT02952820, E2006-G000-303). This pilot study (NCT04009577, E2006-A001-312) was designed to assess pre-specified dosing approaches for directly transitioning from the sedative-hypnotic zolpidem (ZOL), a commonly prescribed sleep aid, to LEM.

Methods

This multicenter pilot study has enrolled subjects age ≥18 years with an insomnia diagnosis (DSM-5 criteria), who used ZOL (intermittently or frequently) as their only insomnia treatment. Following a 3-week Screening period, eligible subjects enter the Treatment Phase (2-week titration period: assigned to 1 of 3 treatment arms based on ZOL use during Screening), and then the Extension Phase (maintenance period up to 12 weeks). During both the Treatment and Extension Phases, the dose of LEM is flexible between 5 and 10 mg, depending on efficacy and tolerability. The primary endpoint is to evaluate the proportion of subjects taking ZOL who successfully transition to LEM (lemborexant 5 mg [LEM5] or lemborexant 10 mg [LEM10]) after 2 weeks of LEM treatment.

Results

Enrollment began July 15, 2019. It was initially projected that approximately 110 subjects would be screened to provide about 60 subjects for randomization across 3 treatment arms. Interim data will be presented (planned cutoff date Jan 08, 2020).

Conclusion

This pilot study will help inform on dosing guidance when transitioning a patient from a GABA-ergic drug to an orexin receptor antagonist.

Support

Eisai Inc.
0482 A Preliminary Study on the Efficacy of Forehead-Cooling for Relieving Menopausal Sleep Difficulties and Hot Flashes
Authors: Baker F C , de Zambotti M , Chiappetta L , Nofzinger E
Published: May 2020

Introduction

Many women experience sleep difficulties in the approach to menopause and post-menopause, with about 25% experiencing severe symptoms that impact daytime functioning and quality of life. Hot flashes contribute to these sleep difficulties, being associated with nocturnal awakenings, poorer sleep quality, and chronic insomnia. New non-pharmacological sleep solutions have become available, including a forehead cooling device designed to target elevated brain metabolism in insomnia sufferers. Here, we explored whether this device was effective in improving subjective sleep and hot flashes in menopausal-age women with insomnia symptoms.

Methods

This study was an open-label, in-home investigation of the efficacy of nightly treatment with a forehead cooling device in 20 women (55.1 ± 4.2 years) with insomnia symptoms and daily hot flashes. Participants completed daily diaries assessing sleep quality and hot flashes across a baseline week (no treatment) followed by 4 weeks of treatment. They also completed questionnaires before and after treatment including the insomnia severity index and the hot flash related daily interference scale.

Results

Women reported better sleep quality with a shorter sleep onset latency and fewer awakenings (between 14-30% improvement) during the first week of device use, with further improvements over time, relative to baseline (p <0.001). Women also reported fewer nocturnal hot flashes that were less severe during treatment (p<0.001). They had lower insomnia severity scores post-treatment (9.3±5.8) compared to pre-treatment (20.0±5.7) (p<0.001), with 17 participants showing a reduction of 6 points or greater on the insomnia severity index. There was also a significant reduction in hot flash related daily interference post-treatment (p<0.001).

Conclusion

Use of a forehead cooling device during the night improved subjective sleep quality and reduced insomnia symptoms and hot flash frequency and severity in this preliminary study of menopausal-age women. Further large scale randomized controlled trials are required to determine efficacy.

Support

Ebb Therapeutics
0496 Self-Reported Sleep During Discontinuation of Chronic Hypnotic Use
Authors: Verkler J , Koshorek G , Roth T , Roehrs T
Published: May 2020

Introduction

Inability to discontinue chronic hypnotic use by people with insomnia remains a clinical concern. Self-reported sleep in an on-going “blinded” clinical trial in which people with insomnia are instructed to discontinue their study medication after 6 months of nightly use was examined and compared to objective actigraphic recordings of their sleep.

Methods

DSM-V diagnosed people with insomnia (n=31, 26 females), aged 26-61 yrs, with a polysomnographic sleep efficiency of ≤85%, no other sleep disorders, unstable medical or psychiatric diseases or drug dependency completed the clinical trial. Participants were randomized to zolpidem XR (12.5 mg), eszopiclone (3 mg) or placebo nightly for 6 months (blinded groups A: n=11, B: n=9, C: n=11). After 6 months, over a 2-week choice period, they were given the instruction to discontinue their nightly hypnotic use with an opportunity, if necessary, to self-administer either 1, 2, or 3 capsules of their assigned 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). On post-sleep questionnaires they reported sleep latency (LAT), wake after sleep onset (WASO), and sleep quality (Q:1-5; best - worst).

Results

15 subjects stopped taking study medication when told to discontinue. The 16 subjects who took study medication had shorter LAT on nights they took capsules then on nights they did not (31 vs 38 min, p<.03), less WASO (22 vs 44 min, p<.02) and better Q (2.3 vs 3.2, p<.002). In contrast, actigraphic recordings of sleep showed no differences in LAT, WASO, or SE.

Conclusion

For subjects who took study medication during the nights they were instructed to discontinue, they reported better sleep than on the nights they used no medication, although objectively their sleep did not differ.

Support

NIDA, grant#: R01DA038177 awarded to Dr. Roehrs
0508 Transcranial Magnetic Stimulation Shows Favorable Response for Insomnia in Depression with Greater Response in Males and in Those Less Than 65 Years of Age
Authors: Stultz D J , Osburn S , Burns T , Stanley N , Walton R , Cope A , Pawlowska-Wajswol S
Published: May 2020

Introduction

Transcranial Magnetic Stimulation (TMS) is FDA approved for the treatment of resistant depression and multiple studies have demonstrated improvement of insomnia in both those with and without depression.

Methods

50 patients were studied while undergoing TMS treatment for resistant depression and utilizing the Patient Health Questionnaire-9 (PHQ-9), the Beck Depression Inventory (BDI), the Insomnia Severity Index (ISI), and the Pittsburgh Sleep Quality Index (PSQI) for evaluation of benefit. Using the Brainsway dTMS system over the LDPFC at 120% MT for an average of 31 treatments, our study demonstrated benefit for both mood and insomnia. We observed an improvement on the PHQ-9 from 17.3 to 7.53, on the BDI from 30.44 to 11.75, on the ISI from 13.47 to 9.31, and on the PSQI from 11.78 to 9.08. Focusing specifically on the insomnia response, we compared an equal number of both male versus female patients, and those > and < than 65 years of age.

Results

Using paired t-test comparisons, men and those less than 65 demonstrated statistically significant improvement. The male population demonstrated statistically significant decreases of t=2.39, 13df, P=.03 on the ISI, and t=2.59, 13df, P=.02 on the PSQI. For women the result was t=1.35, 13df, P=.20 on the ISI, and t=2.05, 13df, P=.06 on the PSQI. In the elderly (>65) decreases were not statistically significant at t=.62, 14df, P=.54 on the ISI, and t=1.26, 14df, P=.23 on the PSQI. For those < 65 years old statistically significant decreases observed were t=3.37, 14df, P=.005 on the ISI, and t=3.5, 14df, P=.004 on the PSQI.

Conclusion

TMS treatment of depression resulted in statistically significant benefits on co-existing insomnia in males and those less than 65 years of age. As insomnia may be a precipitating or perpetuating factor in depression and may result in depression relapse, attention to this symptom is of clinical benefit.

Support

**No support was given for this study. Dr. Stultz is a speaker for Harmony Biosciences and has served on their advisory committee. She is also a speaker for Jazz Pharmaceuticals. She is the co-editor for the Clinical TMS Society Newsletter and on the education committee.
0535 Evaluation of Insomnia Symptoms in a Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial of Sage-217 in Postpartum Depression
Authors: Mittal A , Deligiannidis K , Huang M , Suthoff E , Acaster S , Fridman M , Li S , Gunduz-Bruce H , Lasser R , Campbell A D , Bonthapally V , Hodgkins P , Kanes S J , Werneburg B
Published: May 2020

Introduction

Postpartum depression (PPD) is a specifier of major depressive disorder (MDD) with peripartum onset. SAGE-217, an investigational, oral neuroactive steroid GABAA receptor positive allosteric modulator, demonstrated improvements in depressive and anxiety symptoms versus placebo in a Phase 3 trial in PPD (NCT02978326; ROBIN) and a pivotal trial in MDD (NCT03000530). In PPD and MDD, insomnia symptoms are key diagnostic features, comorbid sleep disorders are frequent, and insomnia is a common residual symptom. Here we conducted post-hoc analyses to assess insomnia symptoms in the ROBIN trial.

Methods

Women (n=151) ages 18-45, ≤6 months postpartum, with PPD (major depressive episode beginning in 3rd trimester or ≤4 weeks postpartum) and a Hamilton Rating Scale for Depression (HAM-D) total score ≥26, were randomized 1:1 to receive outpatient SAGE-217 30mg or placebo for two weeks, with 4 weeks follow-up. Change from baseline (CFB) in HAM-D score at Day 15 was the primary endpoint. Secondary endpoints included CFB in HAM-D at other time points and the Montgomery-Åsberg Depression Rating Scale (MADRS). Post-hoc analyses assessed HAM-D insomnia subscale (HAM-D-Ins) and MADRS individual insomnia item (MADRS-Ins) scores. HAM-D and MADRS measures were evaluated using a mixed-effects model for repeated measures. Safety and tolerability were assessed by adverse event (AE) reporting.

Results

SAGE-217 demonstrated statistically significant Day 15 CFB versus placebo in HAM-D (primary endpoint: -17.8 vs. -13.6, p=0.0028), MADRS (-22.1 vs. -17.6, p=0.0180), and associated insomnia sub-scales/items (difference SAGE-217 vs. placebo; HAM-D-Ins: -1.003, p=0.0038; MADRS-Ins: -0.773, p=0.0116). Significant CFB in insomnia sub-scales/items favoring SAGE-217 were observed by Day 3 (HAM-D-Ins: -0.841, p=0.0142; MADRS-Ins: -0.710, p=0.017) and at Day 45 (HAM-D-Ins: -0.730, p=0.0207; MADRS-Ins: -0.636, p=0.0221). Most common (≥5%) AEs were somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, and sedation.

Conclusion

SAGE-217 demonstrated improvements in depression symptoms, including insomnia symptoms, and was generally well tolerated.

Support

This study was sponsored by Sage Therapeutics, Inc.
0536 Motivation at Pretreatment and its Correlates in a Trial of Digital CBT For Insomnia: Preliminary Findings
Authors: Ji X , Cheung J M , Ivers H , Morin C M
Published: May 2020

Introduction

Pretreatment motivation is a critical variable in any intervention seeking to modify behaviors. Lack of motivation may hamper the effects of cognitive-behavioral therapy for insomnia (CBT-I), especially when delivered online. This study aims to investigate baseline correlates of pretreatment motivation and its influence on treatment outcomes in the context of digitalized CBT-I.

Methods

This is a secondary analysis of an ongoing pragmatic trial conducted in primary care clinics of Québec City, Canada. The trial was designed to assess the efficacy of a stepped-care intervention for chronic insomnia in which participants received a digital CBT-I (SHUTi), alone or in addition to sleep medication they were already using. Pre-treatment motivation was measured using two items based on the perceived importance of improving sleep and readiness to change behaviors to improve sleep (Score range: 0 to 20; cronbach’s alpha 0.79). Baseline questionnaires included an extended version of Insomnia Severity Index (ISI), Fatigue Severity Scale (FFS), Generalized Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9). Treatment outcome was measured by a change in ISI scores (i.e. ISI post - ISI pre).

Results

A total of 28 participants were included in the analysis. All participants preferentially selected ISI either as monotherapy (n=13)or in combination with their usual sleep medication (n=15). Participants’ motivation before treatment was high (Mean: 18.04; SD: 1.93). We did not find any associations between motivation and ISI score change or incidence of dropout. However, baseline fatigue was positively correlated with pretreatment motivation (r = 0.51, p = 0.005) and more severe insomnia symptoms were also associated with higher motivation (r=0.43, p=0.03). Specifically, perceived importance was associated with both nighttime and daytime insomnia symptoms while readiness for behavioral change was only associated with daytime impairments on energy, mood and social activities (all p = 0.01). Baseline anxiety and depressive symptoms were not correlated with motivation.

Conclusion

Insomnia-related daytime impairments and elevated fatigue levels appear to be linked to pretreatment motivation, especially for behavioral changes. Further study with greater statistic power is warranted to understand the relationship between participants’ motivation and treatment adherence or outcomes.

Support

CIHR0083000212
0541 Exploratory Study of Closed-Loop, Artificial Intelligence Driven Neurotechnology Improves Self-Reported Symptoms of Insomnia, Stress, and Anxiety in First Responders
Authors: Tegeler C L , Howard L J , Brown K L , Kellar D C , Shaltout H A , Gerdes L , Tegeler C H
Published: May 2020

Introduction

First responders (FR) have decreased life expectancy, attributed to work-related exposure to traumatic stress and circadian disruption. In prior studies, High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) reduced symptoms and improved heart rate variability (HRV) in law enforcement personnel. HIRREM is operator dependent, difficult to scale, and many medications were excluded for prior studies. Cereset Research™ (CR) uses HIRREM core technology, echoing tones linked to brainwaves, with updated components, artificial intelligence (AI) driven protocols, and software management of designs to improve scalability. We report symptom changes in a series of first responders enrolled in an exploratory study evaluating CR for self-reported symptoms of insomnia, stress, or anxiety, including subjects taking previously excluded medications.

Methods

11 adults (4 females) meeting criteria for insomnia (ISI, of ≥8 points for ≥1 month), stress (PSS of ≥14), or anxiety (GAD-7 of ≥5), who are also FR, enrolled in this ongoing exploratory trial. Subjects receive six to twelve 60 minute sessions of CR, plus continued current care. Data collection is at baseline (V1), 0-21 days post-intervention (V2), 4-7 weeks later (V3), and 4-7 weeks thereafter (V4). Primary outcome is change in autonomic cardiovascular regulation at V3, with change in ISI, PSS, GAD-7, CES-D, and PCL-C as secondary outcomes. We report interim results for symptom outcomes at V3. HRV and baroreflex sensitivity results are pending.

Results

2 dropped out during follow-up. For n=9, median change from V1 to V3 ISI score: -6; PSS score: -4; GAD-7: -4; CES-D: -3; and PCL-C: -8. The cohort moved to no anxiety and low stress categories from V1 to V3.

Conclusion

Results suggest relevant symptom reductions among FR following use of CR, as seen previously with HIRREM for law enforcement, even with additional medications. This informs future randomized clinical trials using this scalable, non-drug intervention. Updated results will be presented.

Support: Support

Research grant received from, The Susanne Marcus Collins Foundation, Inc.
0553 Hallucinogen Use Among College and University Students: Associations with Insufficient Sleep and Insomnia
Authors: Holbert C , Bastien C , c S , Killgore W D , Wills C C , Grandner M A
Published: May 2020

Introduction

Previous studies have shown that poor sleep is associated with alcohol use, smoking, and other substance use, especially among young adults. Yet, very little is known about hallucinogen use.

Methods

Data from the 2011-2014 National College Health Assessment were used (N=113,749), representing a wide range of students across the US. Hallucinogen use was reported as “never,” “past,” and “present” (reflecting use in the past 30 days). Students also self-reported nights/week they did not get enough sleep to feel rested (insufficient sleep), as well as nights/week they had difficulty falling asleep (initial insomnia). Responses for both were categorized as 0, 1-2, 3-4, 5-6, or 7 nights/week. Multinomial logistic regressions examined hallucinogen use as outcome (past or present vs never) and sleep as predictor, with adjustment for covariates (age, sex, race/ethnicity, and survey year) and mental health (past 30 days depression/anxiety).

Results

Hallucinogen use was infrequently reported, with 4.8% (N=5,493) reporting past use and 0.98% (N=1,119) reporting present use. In adjusted analyses, increase likelihood of past use was associated with insufficient sleep on 1-2 (RRR=1.28, p=0.001), 3-4 (RRR=1.37, p<0.0005), 5-6 (RRR=1.30, p<0.0005), and 7 (RRR=1.34, p<0.0005) nights per week, as well as 1-2 (RRR=1.30, p<0.0005), 3-4 (RRR=1.52, p<0.0005), 5-6 (RRR=1.58, p<0.0005), and 7 (RRR=1.49, p<0.0005) nights per week of initial insomnia. Present use was associated with 1-2 (RRR=1.44, p<0.0005), 3-4 (RRR=1.76, p<0.0005), 5-6 (RRR=2.05, p<0.0005), and 7 (RRR=1.83, p<0.0005) nights per week of initial insomnia. When mental health was entered into the model, results were maintained.

Conclusion

Past use of hallucinogens was associated with insufficient sleep as well as insomnia. Present use was also associated with insomnia. When mental health was included in models, all results were maintained. It is not clear whether hallucinogen use leads to, or is predicted by, sleep difficulties.

Support

Dr. Grandner is supported by R01MD011600
0579 Non Intrusive and Unattended Sleep Analyzer Effectively Screens Patients Suspected of Sleep Apnea: A Comparison With Polysomnography
Authors: Edouard P , Campo D , Bartet P , Marais L , Petitjean M , Roisman G , Bruyneel M , Escourrou P
Published: May 2020

Introduction

Sleep Apnea Syndrome (SAS) is largely underdiagnosed due to the cost and availability of Polysomnography (PSG). We aimed at evaluating the diagnosis of SAS with the WITHINGS Sleep Apnea Detector (SAD), a non-intrusive pressure and sound sensor placed under the mattress.

Methods

118 patients (67 F, 49 years, BMI 33kg/m²) suspected of SAS had an in-laboratory PSG together with Sleep Apnea Detector. From the pressure signal, Sleep Apnea Detector derives respiratory and cardiac signals and movements. From the microphone, snoring and snorting are detected. These features are used to detect sleep periods with a Random Forest classifier and apnea and hypopnea events with a Convolutional Neural Network. The Total Sleep Time (TST) and Apnea Hypopnea Index (AHI) deduced (TSTsad, AHIsad) are compared with the PSG results scored according to AASM rules (TSTpsg, AHIpsg). AHI and TST were compared using bias and Mean Absolute Error (MAE). Sensitivity, specificity, likelihood ratios (LR) and AUROC were calculated for AHI thresholds of 15 and 30/hr.

Results

The average (SD) TSTpsg was 367 (61) minutes. Sleep Apnea Detector overestimated TST by 25 minutes, 7.0% of the average duration in the sample. The precision is acceptable, with a MAE=53 minutes. Average AHIpsg was 32.5 (30.1) and AHIsad 32.8 (29.9). The bias was 0.3 (95% CI [-2.7, 3.3]), MAE=10.3. The sensitivity (Se15) and specificity (Sp15) and their 95% confidence intervals were Se15=88.0% [79.0, 94.1] and Sp15=88.6% [73.3, 96.8]. Positive and negative LR were respectively LR+15=7.70 and LR-15=0.136. AUROC15=0.926. At the 30 threshold, Se30=86.0% [73.3, 94.2] and Sp30=91.2% [81.8, 96.7]. Positive and negative LR were LR+30=9.75 and LR-30=0.153. AUROC30=0.954.

Conclusion

Sleep Apnea Detector has excellent sensitivity and specificity, low bias and good precision. Thus it can be used as an unattended SAS screening device in patients likely to suffer from SAS.

Support

WITHINGS
0595 Obstructive Sleep Apnea Characteristics in Younger Versus Older Women
Authors: Budhiraja R , Limbekar N , Quan S
Published: May 2020

Introduction

There are few large studies of obstructive sleep apnea (OSA) comparing the clinical and polysomnographic characteristics between men and women, and between younger and older women.

Methods

The current study involves retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study (APPLES), a prospective multicenter randomized controlled trial in persons with OSA. The mean age of the 1105 participants was 51.6 ± 12 years (range 18-83 years). The participants included 723 men (65.4%) and 382 women (34.6%). Of all women, 25% were <=45 years of age (likely pre-menopausal) and 50% were above >=53 years of age (likely post-menopausal). We used these 2 groups to define younger women and older women, respectively.

Results

The overall mean body mass index (BMI) and apnea hypopnea index (AHI) were 32.2 ± 7.1 Kg/m2 and 40.1 ± 25.2 (range 6-156/hour), respectively. Women had a higher BMI and Epworth Sleepiness Scale (ESS) than men but a lower AHI and lower arousal index (AI). The Hamilton Rating Scale for Depression (HAMD) score was also significantly higher in women. Younger men and women had no other PSG differences including total sleep time (TST), Sleep Efficiency (SE), Sleep Onset Latency (SOL). Older women had lower AHI, higher TST and higher SE than older men. Morningness-Eveningness Questionnaire (MEQ) scores were lower in women than in men in all age groups (suggestive of eveningness). Compared to the older women, younger women had higher BMI, HAMD score and ESS, but lower MEQ score. On PSG, younger women had higher TST and SE but similar SOL, AHI and AI.

Conclusion

In this cohort with OSA, the prevalence of sleepiness and depression is higher in women than in men despite a lower AHI and lower AI. Sleepiness and depression are more common in younger compared to older women with OSA despite similar AHI and AI and a higher SE. Women with OSA demonstrate more ‘eveningness’ compared to men with OSA, as do younger women compared to older women.

Support

Contract 5UO1-HL-068060 from the National Heart, Lung and Blood Institute
0625 The Effects of Topical Nasal Steroids on Continuous Positive Airway Pressure Compliance in Patients with Obstructive Sleep Apnea
Authors: Segsarnviriya C , Mahakit P
Published: May 2020

Introduction

Continuous positive airway pressure (CPAP) for treatment of moderate to severe obstructive sleep apnea can produce troublesome nasal symptoms (i.e. congestion, rhinorrhea, sneezing, itching) that may affect the continuity and decrease the compliance of CPAP. Topical nasal steroids are often prescribed to reduce these side effects, although recent studies are scarce supporting any benefit of this treatment for CPAP-induced nasal side effects.

Methods

80 patients who were previously diagnosed with OSA and pretreatment nasal symptoms were enrolled. All of them were selected for CPAP treatment and divided randomly into two groups. The study group was prescribed Fluticasone furoate nasal spray 55 ug daily before bedtime. The patients’ compliance to CPAP was recorded by the memory card in CPAP device. Total nasal symptom score was assessed using a questionnaire by direct interview. The follow-up was performed in 30 and 90 days after treatment.

Results

The compliance to CPAP (Percent days with usage, Average time usage and Percent of days with usage ≥ 4 hours) increased in both groups with higher significance in topical nasal steroid group (P-value=0.002, 0.001, 0.002) after 90 days of treatment. There was no difference in nasal symptom between both groups after 30 days of treatment. However, addition of topical nasal steroid resulted in decreased rhinorrhea and congestion symptom (P-value <0.001, <0.001) after 90 days of treatment.

Conclusion

The addition of topical nasal steroid decreased the frequency of nasal symptoms (esp. rhinorrhea and congestion) in OSA patients initiating CPAP therapy and increased the compliance to CPAP after 90 days of treatment.

Support

Keywords: Obstructive sleep apnea, Continuous positive airway pressure, CPAP, Topical nasal steroid
0630 Comparison Between the Use of APAP and Manual Titration During Split Night Polysomnography for Diagnosis and Treatment of OSA
Authors: Gharraf H S , Shaarawy H m
Published: May 2020

Introduction

CPAP remains the gold standard treatment for OSA, CPAP titration can be done using manual titration or using APAP devices, CPAP titration can be done using full night or split night protocol. The aim of the study Is to compare between the use of APAP and manual titration to determine the needed CPAP pressure during split night polysomnography for diagnosis and treatment of OSA.

Methods

100 patients with severe OSA were enrolled after exclusion of patients with heart failure or respiratory failure. After diagnostic polysomnography, patients were divided into 2 groups: group1 offered manual CPAP titration and Group2 offered APAP titration, the time for CPAP titration was at least 4 hours in both groups.

Results

both groups were matched as regard age, gender, BMI, sleep parameters and AHI (44.52 ± 7.81/hour in group1 and 42.66 ± 9.68/hour in group2 with no statistical significance, after CPAP titration AHI was significantly improved in both groups, the time needed to reach the therapeutic pressure was significantly lower in group2 than in group1, attended technician was needed only in group1.

Conclusion

Use of APAP was equal to manual titration in this group of patients with severe OSA, with decreased cost and lesser time to reach the therapeutic pressure, large multicenter trials are needed to modify the guidelines in view of using APAP in split night protocol for diagnosis and treatment of OSA.

Support

no conflict of interest
0654 Obstructive Sleep Apnea in Older Adults: Geographic Variation in CPAP Treatment
Authors: Yu Y , Levine R S , Braley T J , Burke J F , Chervin R D , Dunietz G L
Published: May 2020

Introduction

Obstructive sleep apnea (OSA) is prevalent and consequential among older adults. Positive airway pressure (PAP) is likely to reduce associated morbidity, but adherence is inconsistent. Regional treatment variations that may reflect addressable differences in care are not sufficiently studied. We examined geographic variations in PAP treatment among older US adults.

Methods

A representative 5% sample of all Medicare beneficiaries, age 65+, enrolled in fee-for-service program in 2013 was analyzed. OSA diagnosis was defined by ICD-9 codes. PAP treatment was identified by HCPCS codes. Treatment adherence was defined as ≥2 HCPCS claims for PAP supplies on separate months. We examined state-specific proportions of Medicare beneficiaries with OSA who obtained PAP and showed adherence. Maps were created to represent state-specific proportions of beneficiaries who were treated and adherent, by quantiles. To examine more granular regional variations, we created maps representing hospital referral region (HRR)-specific proportions of treated among diagnosed, and adherent among treated. Scatterplots were used to identify the relationship between proportions of PAP treatment and adherence, by state.

Results

For the state-level data, PAP treatment and adherence rates were between 54%-87% and 59%-81%, respectively. Midwest states had higher CPAP treatment proportions (>80%), while Northeast, Southwest and Southern states had CPAP treatment rates <73%. State-level CPAP adherence showed similar patterns, with lowest rates in southern states and California (<70%). Within-state variability of treatment patterns were observed, especially along the east and the west coasts. A scatterplot revealed that state-level CPAP treatment and adherence rates were linearly correlated, with Washington D.C., NY and NJ ranked lowest. In contrast, MT, ND and VT had the highest treatment and adherence rates.

Conclusion

These data show substantial state-level and regional variability of CPAP treatment and adherence among Medicare beneficiaries. Some geographic areas may merit prioritization in efforts to improve OSA treatment and adherence.

Support

This study was supported by The American Sleep Medicine Foundation Strategic Research Award 115-SR-15
0665 Bilateral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea
Authors: Eastwood P R , Barnes M , MacKay S G , Wheatley J R , Lewis R , Campbell M C , Jones A C , Palme C E , Petelle B , Meslier N , Bertolus C , Denoncin K , Attali V , Gagnadoux F , Launois S H
Published: May 2020

Introduction

Hypoglossal Nerve Stimulation (HGNS) decreases obstructive sleep apnea (OSA) severity by contracting the tongue and decreasing upper airway collapsibility. This study assessed the safety and effectiveness of a new implantable device that delivers bilateral HGNS: the Genio™ system.

Methods

The BLAST OSA study (BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnea), was a prospective, open-label, non-randomized, single arm treatment study conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were the incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. Participants were eligible if: 21-75 years old; BMI ≤ 32 kg/m2; obstructive AHI 20-60 events/hr and combined central and mixed AHI < 10 events/hr; no positional OSA; no Complete Concentric Collapse of the soft palate during Drug Induced Sleep Endoscopy; and failed to tolerate or accept Positive Airway Pressure treatments.

Results

27 participants were implanted (63% male, aged 55.9±12.0 years, BMI 27.4±3.0 kg/m2). 22 completed the protocol. At 6 months, AHI decreased from 23.7±12.2 to 12.9±10.1 events/hr [p<0.001]; and ODI decreased from 19.1±11.2 to 9.8±6.9 events/hr [p<0.001]. Daytime sleepiness (ESS, p=0.011) and sleep-related quality of life (FOSQ-10, p=0.016) both significantly improved. 91% of participants reported using their device >5 days per week, and 77% used it >5 hours per night. The number of bed partners reporting disruptive snoring decreased from 96% to 35%. No device-related SAE occurred.

Conclusion

In a targeted population of individuals with moderate-to-severe OSA, the Genio system reduced OSA severity and sleepiness, improved quality of life, and was associated with high adherence and an acceptable safety profile.

Support

This study trial was funded by Nyxoah S.A. This trial was registered with ClinicalTrials.gov, number NCT03048604.