bluuebunny/crossref_metadata_2025 huggingface dataset:
0381 Association of Social Jetlag with the 2018 WCRF/AICR Cancer Prevention Score Among Parent-Adolescent Dyads in the FLASHE Study
Authors: O’Connor S G , Shams-White M M , Czajkowski S , Oh A
Published: May 2020

Introduction

Social jetlag (SJL), or the mismatch between biological and social time, is a marker of circadian misalignment. SJL is linked to biological and behavioral alterations (e.g., adiposity, unhealthy food intake) which over time may increase cancer and chronic disease risk. While developmental changes exacerbate SJL among adolescents, parents may also influence adolescent behavioral patterns. This study examined associations of SJL with multiple cancer preventive behaviors among parent-adolescent dyads using the 2018 World Cancer Research Fund/American Institute of Cancer Research (WCRF/AICR) Cancer Prevention Score in the National Cancer Institute’s Family Life, Activity, Sun, Health, and Eating (FLASHE) Study.

Methods

Online cross-sectional surveys examining cancer-preventive behaviors were administered to 1,479 parent-adolescent (aged 12-17y) dyads in 2014. SJL was defined as the absolute difference between sleep midpoint on weekend and week days. The adapted 2018 WCRF/AICR Score ranged from 0-6 and was the sum of six sub-components representing adherence to specific cancer prevention recommendations concerning body weight, physical activity, and diet. Dyads with missing data on either variable were excluded. Actor-partner interdependence modeling was used to determine within-dyad correlations, actor (i.e., effect of a dyad member’s SJL on own score), and partner (i.e., effect of a dyad member’s SJL on partner’s score) effects.

Results

The analytical sample included 936 dyads. Mean SJL was 2.0 hours (SD: 1.2) for adolescents and 1.2 hours (SD: 0.9) for parents. Mean WCRF/AICR Scores were 4.1 (SD: 0.9) for adolescents and 4.0 (SD: 0.9) for parents. Within dyads, SJL (r=0.29) and the WCRF/AICR Score (r=0.41) were positively correlated (all p <0.0001). Among adolescents, greater SJL was associated with a lower WCRF/AICR Score (β= -0.077, SE: 0.03, p=0.003), but this relationship was not observed among parents. No partner effects were detected.

Conclusion

Among adolescents, SJL was associated with poorer adherence to cancer prevention recommendations. SJL may represent a modifiable risk factor with the potential to improve multiple health behaviors and decrease disease risk.

Support

FLASHE was funded with federal funds from the National Cancer Institute, National Institutes of Health (NIH), under contract number HHSN261201200039I issued to Westat, Inc
0410 Insufficient Sleep Among Healthcare Professionals
Authors: Jenkins D , Peprah R , Donley T , Sexias A , Khosrof A , Jean-Louis G
Published: May 2020

Introduction

Insufficient sleep (IS) is a common problem among healthcare professionals, especially those who are shift workers. Evidence has shown that sleeping less than eight hours can lead to sleep debt. Sleep debt can have a negative impact on the mental, emotional and cognitive well-being of health care providers. In addition to sleep debt, having long shift hours reduces the opportunity for sleep because there is less time to recuperate.

Methods

We analyzed data gathered from healthcare workers (n=4,093) from the 2017 and 2018 National Health Interview Survey (NHIS), a nationally representative study of the US civilian non-institutionalized population. Sleep was categorized as short (≤6 hrs), normal/healthy (7-8 hrs), and long (≥9 hrs) sleep. Using STATA 15.0 for Windows, we report weighted frequencies and Chi square tests. Alpha of 0.05 was used for all significance levels.

Results

Of the sample, 18% were male and 82% were female. The mean age was 50.7±17.5. The majority of the sample was White (77%), 12% were Black and 9% were of other minority”. The proportion of women who reported short sleep (31%) and normal (45%) were significantly higher than men (p<0.000). Healthcare workers under 30 had the highest proportions of short sleep compared to any other age groups (p<0.000). Lower numbers were associated with long sleep among those who worked directly with patients compared to workers who did not (p<0.000). Healthy sleep was significantly associated with not having trouble falling asleep, staying asleep, not taking sleep medications, and feeling rested 7 or more times in the past week (p<0.000).

Conclusion

Our study explores sleep patterns among healthcare professionals. Previous studies have shown that this population is more susceptible to insufficient sleep which leads to sleep debt. We found that the current data suggest that this association may have changed for healthcare professionals today.

Support

This study was supported by funding from the NIH: R01MD007716, R01HL142066, K01HL135452, and K07AG052685.
0419 IL-6 Moderates the Association Between Obstructive Sleep Apnea Severity and Incident Alzheimer’s Disease: The Framingham Heart Study
Authors: Baril A , Beiser A S , Redline S , McGrath E R , Aparicio H J , Gottlieb D J , Seshadri S , Himali J J , Pase M P
Published: May 2020

Introduction

Both sleep disturbances and inflammation are potential risk factors for Alzheimer’s disease (AD). However, it is unknown how inflammation and sleep interact together to influence the risk of developing AD dementia. Our objective was to evaluate whether interleukin-6 (IL-6) levels interact with sleep disturbances when predicting incident clinical AD.

Methods

We studied participants in the Framingham Heart Study Offspring cohort who completed in-home overnight polysomnography. Sleep characteristics were continuous and included sleep duration, wake after sleep onset (WASO), and apnea-hypopnea index (AHI). Participants were stratified into quartiles of IL-6 levels. Surveillance for incident AD dementia occurred over a mean follow-up of 13.4±5.4 years. Using Cox proportional hazards regression models, we tested the interaction of sleep measures by IL-6 quartiles on incident AD dementia. All analyses adjusted for age and sex and P<0.05 was considered significant.

Results

The final sample included 291 dementia-free participants at baseline (age 67.5±4.9 years, 51.6% men). Approximately one quarter of participants had obstructive sleep apnea (OSA; AHI>15) at baseline (median:6.2, Q1:2,3, Q3:14.3). We observed 33 cases of incident AD dementia during follow-up. Although no interaction was observed for either sleep duration or WASO with IL-6 levels, there was a significant interaction of AHI with IL-6 in predicting AD dementia (p=0.002). In the lowest IL-6 quartile, higher AHI was associated with an elevated risk of AD dementia (hazard ratio, 4.15 [95%CI, 1.42, 12.1], p=0.01) whereas no association between AHI and incident AD was observed in other IL-6 quartiles.

Conclusion

Our findings suggest that the pro-inflammatory cytokine IL-6 moderates the association between OSA and incident AD risk. The association between increasing OSA severity and incident AD was only observed in those with lower IL-6 levels, suggesting that this association might be especially apparent when no other confounding risk factors such as inflammation are present.

Support

The Framingham Heart Study is supported by contracts from the National Heart, Lung and Blood Institute, grants from the National Institute on Aging, and grants from the National Institute of Neurological Disorders and Stroke.
0422 Apocalypse Tau: The Relationship Between Inflammaging and Local Sleep Disruption in Older Adults is Mediated by Tau Burden
Authors: Dave A , Sprecher K E , Lui K K , Chappel-Farley M G , Chen I Y , Blennow K , Zetterberg H , Riedner B A , Bendlin B B , Mander B A , Benca R M
Published: May 2020

Introduction

Chronic inflammation in aging is independently associated with tau burden and sleep disruption, though the mechanism linking inflammation with sleep disruption remains unknown. Recent evidence associates tau burden with deficits in local expression of sleep spindles and slow wave activity (SWA). Here we test the hypothesis that age-related central inflammation disrupts local sleep by influencing tau pathology.

Methods

Cognitively asymptomatic older adults from the Wisconsin Alzheimer’s Disease Research Center underwent overnight polysomnography with high-density electroencephalography (hdEEG; 256 channels) at the University of Wisconsin-Madison (n=33, 61.9±6.7 years, 23 female). EEG data were subjected to multitaper spectral analysis (0.5-40Hz) to yield topographic maps of SWA (SWA1:0.5-1Hz, SWA2:1-4.5Hz) and spindle (sigma1:11-13Hz; sigma2:13-16Hz) power during NREM sleep. Cerebrospinal fluid assay-based measurements of YKL-40 (indicating glial activation), phosphorylated tau (Ptau), and total tau (Ttau), were correlated with SWA and sigma topographical power employing Holm-Bonferroni correction. Multiple linear regression models were implemented controlling for age, apnea-hypopnea index (AHI), and sex at significant derivations. Finally, Sobel testing was employed to assess whether tau burden mediated YKL-40-sleep associations.

Results

Age was associated with YKL-40 (r=0.53, p=0.002), and YKL-40 was associated with both Ptau (r=0.66, p<0.001) and Ttau (r=0.68, p<0.001). Correlations between sigma2 activity and both Ptau and Ttau were detected at 14 derivations, 12 of which remained significant after controlling for age, sex, and AHI. YKL-40 was associated with sigma2 power (r=-0.39, p=0.025) across derivations expressing peak significance with tau. Sobel mediation analyses indicated that both Ptau (t=-2.15, p=0.031) and Ttau (t=-2.36, p=0.018) mediated the relationship between YKL-40 and sigma2 activity at these derivations. SWA was not associated with Ttau, Ptau, or YKL-40.

Conclusion

These results suggest that age-related increases in central glial activation may disrupt local expression of fast spindles by increasing tau burden, highlighting a potential role for chronic inflammation in sleep deficits observed in aging and Alzheimer’s disease.

Support

Supported by R56 AG052698, P50AG033514
0424 Effect of Chronic Intermittent Hypoxia on Global Cerebral Metabolic Rate of Oxygen Consumption in Rats
Authors: Xu J , Geng E , Brake L , Wiemken A , Keenan B , Kubin L , Schwab R
Published: May 2020

Introduction

Patients with obstructive sleep apnea (OSA) commonly exhibit grey and white matter loss, which may be related to hypoxic damage in the brain during sleep. Our preliminary data demonstrated lower values of cerebral metabolic rate of oxygen (CMRO2) consumption in apneics versus controls. As such, reduced CMRO2 may be an important contributor to the neurologic consequences of OSA. Here we report a rodent model for chronic intermittent hypoxia (CIH) to quantify effects on CMRO2 consumption. We hypothesized that increased severity of CIH results in decreased CMRO2 levels.

Methods

Three groups of rats were subject to varying levels of hypoxia: sham (21% oxygen; n = 19), moderate (11% oxygen; n = 14), and severe (6% oxygen; n = 21). To deliver hypoxia, rats were exposed to three-minute cycles of oxygen between 21% and condition-specific nadir O2 for 12 hours daily during their sleep cycle. CMRO2 values were measured with MRI techniques, performed on anesthetized rats before and after 3 months exposure to CIH.

Results

Rats from the three hypoxia groups did not differ significantly in CMRO2 values at baseline (0 months). After 3 months of exposure to hypoxic conditions, there was a trending difference (p=0.0726) in percent change from baseline between severely hypoxic (-35.3%) and sham (+12.3%) rats. Moderately hypoxic rats demonstrated an intermediate decrease from baseline after 3 months (-19.0%).

Conclusion

Our findings suggest that increased severity of intermittent hypoxia yields a dose-response decrease in brain oxygen consumption. Our data add to the growing body of evidence on the relationship between obstructive sleep apnea and hypoxic damage in the brain, suggesting that CMRO2 levels may be an indicator of the neurologic consequences of OSA.

Support

Funded by NIH P01 HL094307
0425 Severity of Insomnia Symptoms Differ by Cognitive Status in Adults with Down Syndrome
Authors: Desai S , Chen I Y , Doran E , Hom C , Nguyen D D , Benca R M , Lott I T , Mander B A
Published: May 2020

Introduction

Sleep is disturbed in Down syndrome (DS), with sleep apnea and insomnia prevalent throughout life. Sleep disturbance increases dementia risk and is more prevalent in dementia in non-DS populations. However, relationships between sleep and clinical status in DS remains unclear. We examined informant-reported sleep in adults with DS, with or without a consensus diagnosis of dementia, and related the severity of sleep disturbances to measures of adaptive behavior.

Methods

Insomnia (selected from Children’s Sleep Habits Questionnaire), daytime sleepiness (modified ESS), sleep apnea risk (modified STOP-BANG), and adaptive behavior (Vineland Adaptive Behavior Scales; VABS-3) questionnaires were collected from informants for 47 DS adults (52.1±6.6 years) enrolled in a Alzheimer’s disease biomarker study. Participants’ clinical statuses were categorized as cognitively unaffected (clinically significant impairment absent; n=38, 51.0±6.2 years), or as having definite dementia (clinically significant decline present; n=9, 56.6±6.4 years) using a standard consensus diagnosis procedure. Age was compared between groups using an independent samples t-test. ANCOVA was used to compare insomnia, daytime sleepiness, sleep apnea risk, and adaptive behavior measures across groups, while controlling for age. Partial correlation analyses examined associations between sleep measures and VABS-3 measures while controlling for clinical status.

Results

Participants categorized as definite dementia were older (t=-2.381, p=0.022). ANCOVA determined that insomnia symptoms, but not daytime sleepiness or apnea risk, were more severe in definite dementia participants (F=5.567, p=0.023), even when controlling for age. VABS-3 subscale scores differed by clinical status (all save play and leisure scores p<0.017). Partial correlation analyses adjusting for clinical status indicated that insomnia symptom severity worsened with lower adaptive functioning (e.g., daily living skills—coping r=-0.41, p=0.007; socialization r=-0.33, p=0.024) regardless of clinical status.

Conclusion

These findings indicate that insomnia may be related to functional impairment and dementia in DS adults, and raises the possibility that insomnia treatments may influence dementia course and clinical symptomatology in DS.

Support

NIH U01AG051412
0427 Bicuculine Increased the Cataplexy in the Male Taiep Rats: An Animal Model of Narcolepsy with an Inherent Tubulopathy
Authors: Cortes C , Eguibar J R , Ibarra-Hernandez J M
Published: May 2020

Introduction

Narcolepsy is a hypersomnolence that is characterized by sleep fragmentation, sleep paralysis, hypnagogic hallucinations and cataplexy that is characterized by atonia induced by strong emotions. The amygdala is the trigger for cataplexy through GABAergic mechanisms. Taiep is a myelin mutant with TUBB4A tubulopathy which showed spontaneous episodes of atonia or induced by manipulations from the tail or the thorax. EEG recordings during immobility episodes (IE′s) had a cerebral cortex desynchronized associated to theta rhythm in the hippocampus. The aim of this sturdy was to analyze the effects of bicuculine administration on IE′s and sleep-wake pattern on adult male taiep rats.

Methods

We used 6 taiep male rats at 9 months of age. The subjects (Ss) lived in individual acrylic cages with water and food pellets available ad libitum, under a 12:12 light-dark cycle (lights on at 0700), with controlled temperature and humidity recording room. All Ss were implanted to record EEG, EMG and EOG to characterize EI′s. We evaluated a basal 24 h EEG recording and then after bicuculine i.p. administration of 0.5, 1 y 1.5 mg/Kg every 48h. We measured the number, mean duration and latency to the first IE′s.

Results

The duration of IE′s increased 527% with 1 mg/Kg and reach 700% with 1.5 mg/Kg of bicuculine (P<0.01) with respect to saline-treated control group. Importantly, the frequency of IEs did not differ among the groups and did not affect the number of awake, slow wave or rapid eye movements sleep phases.

Conclusion

Bicuculine, a specific GABA antagonist, modify the duration of IES but not their frequency supporting a role of GABAergic mechanism on IE′s. It is relevant because sodium oxybate, an indirect GABA agonist, reduced cataplexy and improved sleep quality on narcoleptic patients.

Support

CONACYT grants 243333 and 243247 to CC and JRE, respectively and from VIEP-BUAP 2019 to CA in Neuroendocrinología BUAP-CA-288.
0448 Scaled-Up Sleep Apnea Endotyping Using Polysomnography for Clinical Use
Authors: Finnsson E , Jónsson S Æ , Ólafsdóttir G H , Loftsdóttir D L , Helgadóttir H , Ágústsson J S , Wellman D A , Sands S A
Published: May 2020

Introduction

Sleep apnea is caused by several key endophenotypic traits namely pharyngeal collapsibility, poor muscle compensation, ventilatory instability (high loop gain), and arousability from sleep (low arousal threshold). Already, measures of these traits have shown promise for predicting outcomes of therapies (oral appliances, surgery, hypoglossal nerve stimulation, CPAP, or pharmaceuticals) and thus may be an integral part of future precision sleep medicine with treatments administered based on underlying pathophysiology. However, currently, the novel methods developed for endotyping from polysomnography are computationally expensive and can only be performed by the original authors or their collaborators due to the need for technological expertise. Here we present a cloud-based method for endotyping sleep apnea from polysomnography for use in the clinical arena.

Methods

For cloud-based use, we optimized the Phenotype Using Polysomnography (‘PUP’) method of Sands et.al. (2015-2018) by performing the following: Code was translated from MATLAB to Python; efficient methods were developed to detect breaths, calculate normalized ventilation (moving time-average), and model ventilatory drive (intended ventilation). The new implementation (‘PUP.py’) was validated by comparing the measured traits against the original values.

Results

38 manually scored clinical polysomnographic studies were endophenotyped using the two implementations. Results of the new implementation (‘PUP.py’) were strongly correlated with the original (p<10-6 for all): collapsibility and compensation (ventilation at eupneic drive ‘Vpassive’: r=0.98; ventilation at arousal threshold, r=0.97), loop gain (r=0.96), and arousal threshold (r=0.92).

Conclusion

We successfully implemented the original method by Sands et.al. to scale up sleep apnea endotyping and make it available to a broader audience.

Support

This work was supported by the Icelandic Centre for Research RANNÍS, the European Union’s Horizon 2020 SME Instrument (733461), and the American Heart Association (15SDG25890059).
0460 Insomnia In 400 Women: Polysomnography, Immune Parameters, Depression and Anxiety
Authors: Akerstedt T , Ghilotti F , Schwarz J , Theorell-Haglöw J , Lindberg E
Published: May 2020

Introduction

Insomnia disorder has a very weak link to polysomnography (PSG) and so does sleep problems in the general population. The reason for this is not clear. One possibility is that the perception of disturbed sleep may be related to immune activation or anxiety/depression, without impairment of objective sleep.

Methods

400 women participated, constituting a representative sample of the city of Uppsala with oversampling of snorers. Insomniacs (N=41) were compared with normal sleepers in terms of polysomnography (PSG), immune parameters, anxiety and depression

Results

The results (after adjustment for age and BMI) show that C-reactive protein (CRP) reached a higher level (4.4±.5) in insomniacs (vs 2.3±.2 for normal sleepers) (p=.003) and lower subjective health (p=.000), while anxiety (p=.000) and depression (p=.000) (Hospital Anxiety and Depression Scale (HAD)) showed higher levels. PSG sleep continuity variables lacked association with insomnia, as did all sleep stage variables except for REM%, with a lower level in the insomnia group (p=.021). Interleukin 6 and Tumor Necrosis Factor alpha were not related to insomnia. CRP levels did not correlate significantly with anxiety or depression, but with subjective health (r=-.21, p=.000). A logistic regression analysis (excluding the variable subjective health) with insomnia as outcome (0/1) yielded as predictors CRP (OR=1.14, Ci= 1.05; 1.24, p=.000), depression (OR=1.21, Ci=1.06;1.38, p=.000) and anxiety (OR=1.15, Ci=1.02;1.30, p=.021).

Conclusion

It was concluded that increased CRP levels may be part of the subjective experience of insomnia.

Support

No external funding
0486 Impact of Intrinsic Factors on Efficacy of Lemborexant: Subgroup Analyses of SUNRISE-2
Authors: Moline M , Inoue Y , Kubota N , Pinner K , Perdomo C , Yardley J
Published: May 2020

Introduction

Lemborexant (LEM), a dual orexin receptor antagonist, demonstrated significant benefits vs placebo on patient-reported sleep outcomes in adults age ≥18y in SUNRISE-2 (NCT02952820; E2006-G000-303). The impact of intrinsic factors (sex, race, and region) on LEM efficacy outcomes was assessed.

Methods

SUNRISE-2 was a randomized, double-blind, global phase 3 study in adults age ≥18y with insomnia disorder (Full Analysis Set, n=949). Subjects received placebo (n=318) or LEM (5mg [LEM5], n=316; 10mg [LEM10]; n=315) for 6 months. At 6 months, placebo subjects were rerandomized to LEM for another 6 months (not reported here); LEM subjects remained on their assigned dose. Sleep diary-based (subjective) sleep onset latency (sSOL) and wake after sleep onset (sWASO) were assessed for prespecified patient subgroups including: sex (male [n=302], female [n=647]), race (white [n=679], black [n=76], Asian [n=178]), and region (North America [n=302], Europe/New Zealand [n=483], Asia [n=164]). Analyses were not controlled for multiplicity.

Results

LEM5 and LEM10 provided numerically greater median reductions (improvement) from baseline in sSOL vs placebo at 6 months in across all subgroups examined. Also, LEM5 and LEM10 led to mean reductions (improvement) from baseline at 6 months in sWASO for all subgroups. While several subgroups had small numbers of subjects, changes from baseline in sSOL and sWASO were in the direction of improvement in the majority of subgroups. Pharmacokinetic analyses showed no important differences in exposure by these factors.

Conclusion

LEM treatment demonstrated efficacy in improving sSOL and sWASO across patient subgroups, supporting common dosing instructions for both sexes and all races.

Support

Eisai Inc.
0487 Effects of Suvorexant on Sleep Architecture in Patients with Alzheimer’s Disease and Insomnia
Authors: Svetnik V , Wang T , Ceesay P , Ceren O , Snyder E , Bliwise D , Budd K , Hutzelmann J , Stevens J , Lines C , Michelson D , Herring W
Published: May 2020

Introduction

Suvorexant, an orexin receptor antagonist that enables sleep to occur via competitive antagonism of wake-promoting orexins, improved total sleep time (TST) in a sleep laboratory polysomnography (PSG) study of patients with AD and insomnia. Here we report on the effects of suvorexant on sleep architecture in the study.

Methods

This was a randomized, double-blind, 4-week trial (ClinicalTrials.gov NCT02750306). Participants who met diagnostic criteria for both probable AD dementia (of mild to moderate severity) and insomnia were randomized to suvorexant 10mg (could be increased to 20mg based on clinical response) or matching placebo. Overnight sleep laboratory PSG was performed on 3 nights: screening, baseline, and Night-29 (last night of dosing). Suvorexant differences from placebo in changes-from-baseline at Night-29 for sleep architecture were analyzed as exploratory endpoints.

Results

A total of 274 participants were included in the analysis (suvorexant N=135, placebo N=139). At Night-29, suvorexant improved TST by 28 minutes versus placebo (p=0.001). There were no significant differences between suvorexant and placebo in the % of TST spent in REM (1.3%, 95% CI: -0.5, 3.0), N1 (0.6%, 95% CI: -1.2, 2.5), N2 (-1.0%, 95% CI: -3.2, 1.2), or N3 (-0.6%, 95% CI: -1.8, 0.6). There was no significant difference between suvorexant and placebo in latency to REM (-5.4 minutes, 95% CI: -23.4, 12.7).

Conclusion

Suvorexant improves TST without altering the underlying sleep architecture in AD patients with insomnia.

Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
0489 Initial Results from the Hypertension with Unsatisfactory Sleep Health (HUSH) Clinical Trial for Primary Care Patients with Insomnia and Comorbid Hypertension (INS-HTN)
Authors: Buysse D J , Ritterband L M , Yabes J G , Rollman B L , Strollo P J , Smith K J , Patterson C M
Published: May 2020

Introduction

Insomnia is commonly comorbid with, and may contribute to, hypertension. Cognitive-behavioral treatments improve insomnia, but their effects on hypertension are uncertain, and they are often unavailable in primary care practices, where most INS-HTN patients are treated. We evaluated the efficacy of Brief Behavioral Treatment for Insomnia (BBTI) and Sleep Healthy Using the Internet (SHUTi) compared to enhanced usual care (EUC) on insomnia and home blood pressure (HBP) in primary care patients with INS-HTN.

Methods

Patients were recruited via electronic health records from 67 primary care practices and randomized 2:2:1 to BBTI delivered via telephone/videoconferencing; SHUTi, an automated, web-based CBT-I program; or EUC including a patient education video. Assessments included self-report questionnaires, home sleep apnea testing, and one week of sleep diary and HBP, measured at Baseline and 9 weeks/ 6 months post-treatment. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance scale. Linear mixed models were fitted for continuous variables on the intent-to-treat sample (n=548), adjusting for age and sex. Chi-square tests were used for proportions.

Results

Patients were 61.8±11.3 years old, 67.2% female, and 55.9% were taking hypnotics. Insomnia Severity Index (ISI) was 15.4±4.4, Apnea-Hypopnea Index 9.8±11.4, and HBP 130±14/81±9. BBTI and SHUTi were significantly better than EUC (p≤.002) at 9 weeks and 6 months on PROMIS Sleep Disturbance and Sleep-Related Impairment scales, ISI, and diary sleep efficiency, but had inconsistent effects on PROMIS depression and anxiety scales (p=0.001-0.9). Greater proportions of BBTI and SHUTi vs. EUC-treated patients had 9-week and 6-month ISI scores <8 (p=.01, p=.04) and ISI changes scores ≥7 (p=.002, p=.003). HBP did not significantly differ by intervention group.

Conclusion

BBTI and SHUTi improved insomnia, but did not reduce HBP in patients with INS-HTN. These interventions appear suitable for dissemination and implementation in primary care, but may have limited effects on comorbid symptoms and conditions.

Support

NHLBI UH2/UH3 HL125103
0490 Development and Preliminary Evaluation of a Brief Intervention for Post-Deployment Insomnia
Authors: Mellman T , Howell M
Published: May 2020

Introduction

Sleep disturbances are common among previously deployed Veterans. Cognitive behavioral therapy for insomnia (CBT-I) has shown promise for Veterans but there are limitations and CBT-I may not optimally target the nocturnal vigilance conditioned by threatening environments. We developed and preliminarily evaluated a brief educational/behavioral intervention that combined established behavioral sleep principles with cognitive exercises intended to reduce the impact of vigilant thoughts and behaviors on sleep.

Methods

Participants were 40 Veterans recruited from the community and local VAMC who had been deployed to combat zones or hazardous duty areas. The mean age was 40, and the majority were male, African American, and screened positively for PTSD. They were assigned to the study intervention or an educational control that utilized a pamphlet promoting healthy sleep habits. Assignment at a 2:1 ratio was intended to allow for refinement of the study intervention during the early phase of the trial. Initial assessment was followed by a week of sleep diary collection, then two intervention sessions a week apart, followed by a repeat assessment. Participants of the study intervention were assessed again 3-months later.

Results

Improvements in sleep efficiency, ratings for feeling rested in the morning, and reduced Insomnia Severity Index scores were seen in the post-treatment week but did not differ between groups. At 3-months, these improvements were sustained in the 14 retained participants of the study intervention, engagement in vigilance reducing exercises remained high, and ratings of how rested one felt in the morning were significantly improved over ratings from the post-treatment week.

Conclusion

Brief behavioral intervention for post-deployment insomnia can provide benefits and cognitive exercises to reduce the impact of vigilant thoughts and behaviors warrant further evaluation.

Support

Supported by W81XWH-14-1-0066 from the Congressionally Directed Peer-Reviewed Medical Research Program of the Department of Defense
0493 Use of Sleep Aid Medication is Associated with Memory Deficits: A Population-Based Study
Authors: Dokkedal-Silva V , Oliveira M M , Galduroz J F , Tufik S , Andersen M L
Published: May 2020

Introduction

Use of medications to treat sleep complaints is a common practice that may incur in cognitive deficits. Evidence, beyond the well-described effects of benzodiazepines on cognition, still needs expansion. This study assessed the use of sleep aid medications of different classes and associated factors on prospective and retrospective memory in a representative populational sample from São Paulo.

Methods

Volunteers in the EPISONO study underwent evaluation through questionnaires and a complete polysomnography exam. A subsample of 500 volunteers (Mean Age=42.9 years; 307 women) was included. Users (N=250) and non-users (N=250; randomly selected among the non-using volunteers) of sleep medication were evaluated regarding scores in 8 subscales and the overall score of the Prospective and Retrospective Memory Questionnaire (PRMQ). Afterwards, users of classes of medications were compared. Covariates, including scores in psychiatric evaluation scales and polysomnographic findings, were added in both segments to identify the factors with highest interference in the results obtained.

Results

Medication users consistently performed worse in prospective memory and short-term internal-cued retrospective memory even when covariates were added. Scores in Beck Anxiety and Depression Inventories, Insomnia Severity Index and variables related to wakefulness and sleep architecture were the covariates with the highest interference in the results. When comparing types of medication, few differences were seen, suggesting that for such analysis, a sample with higher power would be appropriate.

Conclusion

Users of sleep medication presented impairment in prospective memory. Factors such as sleep architecture and continuity, as well as insomnia, anxiety and depression symptoms must be considered when evaluating cognitive deficits and pharmacological treatment in patients with sleep complaints, as they may participate in this relationship. Future studies are necessary to characterize the impact of different medication classes on prospective and retrospective memory.

Support

Our studies are supported by Associação Fundo de Incentivo à Pesquisa (AFIP) and Conselho Nacional de Desenvolvimento Científico Tecnológico (CNPq - Grant #133397/2017-3); S.T. and M.L.A. received CNPq fellowships.
0499 Predictors of Session Attendance in a RCT for CBT-I for Perinatal Insomnia
Authors: Rangel E , Asarnow L , Simpson N , Manber R
Published: May 2020

Introduction

Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for chronic insomnia disorder. However, early treatment dropout can negatively impact the success of treatment. In order to design effective strategies to reduce attrition we need to understand predictors of dropout. In this work, we focus on predictors of treatment session attendance among pregnant women in a randomized controlled trial of CBT-I.

Methods

Participants were 87 pregnant women with insomnia disorder (mean age=32.5, SD=5.1 years) who were enrolled in a randomized controlled trial of CBT-I and were randomized to the CBT-I arm (5 sessions). We did not include women who did not complete treatment due to early labor. The Insomnia Severity Index (ISI) and Edinburgh Postnatal Depression Scale (EPDS) and demographic questionnaires (age, income, and educational background) were administered at screening.

Results

Logistic regression analyses were conducted to identify predictors of number of CBT-I sessions attended during pregnancy. A logistic regression model that included clinical predictors found that the ISI and EPDS were not significant predictors of session attendance. A logistic regression model that included demographic predictors (income, education, and age) was significant (F(3,76)=6.49, p<0.001) with an R² of .204. Independently, income was not a significant predictor (β =.15, p=.32), but education (β =-.21, p<.05) and age (β =-.48, p<.01) were significant predictors of fewer sessions attended. Dropping income from the model, there was a significant age by education effect (β =1.39, p<.05). Among participants with less than a college degree, those who were younger had attended fewer sessions during pregnancy. Among those who completed a college education and above, number of sessions attended did not differ by age.

Conclusion

Pregnant women with insomnia who were randomized to receive CBT-I were more likely to withdraw early from treatment if they were younger and had less than a college education. Further research that focuses on increasing attendance in CBT-I treatment among pregnant women needs to develop strategies to increase retention in this vulnerable population.

Support

NR013662
0504 Efficacy and Safety of Seltorexant in Insomnia Disorder
Authors: Savitz A , Saoud J B
Published: May 2020

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 <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.

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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

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

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 < .05) and SEDIARY (F1,44 = 22.633, p < .0001), and significant reductions in SOLDIARY (F1,44 = 7.031, p < .05) and WASODIARY (F1,39 = 7.411, p < .05). In the actigraphy data, we found a significant interaction in SOLACT (F1,39 = 4.273, p < .05) with an increase in SHEEP SOLACT (t18= 2.36, p < .05). Significant reductions were also observed in WASOACT (F1,44 = 16.459, p < .0001) Finally, we observed a reduction in SOLPSG (F1,26 = 5.037, p <. 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

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

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 < .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 < .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 < .05, ES=1.8) and anxiety (GAD-7 Mdiff=3.3, SDdiff=2.1, p < .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

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 > $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 < .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