bluuebunny/crossref_metadata_2025 huggingface dataset:
357 Daridorexant Does Not Impair Respiratory Function in Patients with Mild/Moderate Obstructive Sleep Apnea Irrespective of Severity
Authors: Boof Marie-Laure , Fietze Ingo , Lederer Katharina , Guern Anne-Sophie , Lemoine Vincent , Dingemanse Jasper , Ufer Mike
Published: May 2021

Introduction

Daridorexant is a dual orexin receptor antagonist developed for the treatment of insomnia. The effect of the highest phase-3 dose of 50 mg daridorexant on nighttime respiratory function was evaluated in patients with mild/moderate obstructive sleep apnea (OSA). This study showed that repeated doses of daridorexant had no clinically meaningful effect on nighttime respiration (i.e., apnea-hypopnea index [AHI] and peripheral oxygen saturation [SpO2]). In the same study, other relevant respiratory endpoints were evaluated.

Methods

In this randomized, double-blind, placebo-controlled, two-period, crossover study, daridorexant or placebo was administered in each period once daily for 5 consecutive nights to 28 patients. Treatment differences (daridorexant – placebo) for total number and mean/longest duration of apneas and hypopneas as well as mean and lowest SpO2 during apnea/hypopnea events in Night 5 were explored using linear mixed-effects modeling. Treatment differences for the above-mentioned endpoints versus AHI during TST at baseline (i.e., OSA severity) was analyzed by linear regression using least square approach.

Results

Of 28 patients enrolled, 25 completed the study and were included in the analysis (n=15/10 with mild/moderate OSA; mean [standard deviation, SD] AHI: 16.3 events/h [8.2]). Compared to placebo, daridorexant increased mean duration of TST and accordingly to a not statistically significant extent the mean number of apneas + hypopneas by 16.4 events (n=103 versus 86.2; 90% confidence interval [CI]: -0.4–33.2]) without difference in mean [SD] AHI between daridorexant (15.1 events/h [7.9] and placebo (14.2 [7.7]). No treatment difference was detected for mean (0.0 sec [-2.6–2.7]) or longest (0.8 sec [-8.9–10.5]) duration of apneas nor for mean (0.2 sec [-2.2–2.5]) or longest (8.3 sec [6.4–23.1]) duration of hypopneas. No treatment difference was observed for mean (0.3% [-0.2–2.1]) and lowest (0.9% [0.3–2.1]) SpO2 during apnea/hypopnea events. Treatment differences for any of the evaluated endpoints did not significantly correlate with AHI at baseline as a marker of OSA severity (r2 ≤ 0.09).

Conclusion

Daridorexant can safely be administered to patients with mild/moderate OSA as treatment differences for respiratory-related endpoints were not of statistical significance and independent of disease severity in the studied population.

Support (if any)

Funded by Idorsia Pharmaceuticals Ltd.
361 Relative Effectiveness of Cognitive Behavioral Therapy and its Components in Improving Insomnia Symptoms in Older Adults
Authors: O’Hora Kathleen , Hernandez Beatriz , Lazzeroni Laura , Zeitzer Jamie , Friedman Leah , Posner Donn , Kushida Clete , Yesavage Jerome , Goldstein-Piekarski Andrea
Published: May 2021

Introduction

The prevalence of insomnia complaints in older adults is 30–48%, compared to 10–15% in the general population. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a first-line, non-pharmacological sleep treatment for Insomnia. However, the relative impact of Behavioral (BT) and Cognitive (CT) components compared to that of CBT-I in older adults is unknown.

Methods

128 older adults with insomnia were randomized to receive CBT-I, BT, or CT. Sleep diaries and the Insomnia Severity Index (ISI) were collected pre- and post-treatment and at a 6-month follow-up. We conducted split-plot linear mixed models with age and sex as covariates to assess within and between subject changes to test effects of group, time, and their interaction on ISI, sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), sleep efficiency (SE), and percent of treatment responders (ISI decrease>7) and remitters (ISI<8). Effect size (d) was calculated by dividing the difference between means by the root-mean-squared error of the mixed effects model.

Results

All treatments lead to a significant improvement across outcome measures at post-treatment (p’s<0.001) and 6-months (p’s<0.01), with the exception of TIB, response, and remission. For TIB, there was a significant Group x Time interaction (p<0.001): while all treatments significantly reduced TIB post-treatment relative to baseline, CBT-I (p<0.001,d=-2.26) and BT (p<0.001,d=-1.59) performed significantly better than CT (p=0.003, d=-0.68). In contrast, at 6-months CBT-I (p<0.001,d=-1.16) performed significantly better at reducing TIB than CT (p=0.195,d=-0.24) or BT (p=0.023,d=-0.61) relative to baseline. There was also a non-significant trend for a Group x Time interaction for remission status (p=0.062). Whereas, the percentage of remitters within all groups post-treatment did not differ from chance (p>0.234), at 6 months, the percentage of remitters was significantly higher than chance in CBT-I (73.63%,p=0.026) and BT (78.08%,p=0.012), but not CT (47.85%,p=0.826). There were no other significant time or interaction effects (all p>0.05).

Conclusion

CBT-I and its components are effective in improving subjective insomnia symptoms in older adults. Evidence suggests CBT-I may be superior to either CT or BT alone in improving TIB in older adults.

Support (if any)

NIMHR01MH101468; MIRECC at VAPAHCS
364 Use of Blinded Hypnotic Tapering for Hypnotic Discontinuation: Final Report
Authors: Edinger Jack , Wamboldt Frederick , Holm Kristen , Johnson Rachel , Simmons Bryan , Tsai Sheila , Morin Charles
Published: May 2021

Introduction

Many patients have difficulties achieving hypnotic discontinuation due to anxiety that arises when they knowingly reduce their hypnotic dose or withhold it entirely. This study tested a blinded tapering approach to reduce patients’ anxiety and help them discontinue their hypnotics.

Methods

The study sample included 78 (M age = 55.2 ± 12.8 yrs.; 65.4% women) users of benzodiazepine and benzodiazepine receptor agonists. Following baseline assessments, enrollees first completed 4 sessions of cognitive behavioral insomnia therapy (CBTI). Subsequently they were randomized to one of three 20-week, double-blinded tapering protocols wherein their medication dosage either remained unchanged (CTRL) or was reduced by 25% or 10% every two weeks. At the end of the 20-week period the study blind was eliminated and those who completed one of the two blinded tapering protocols entered a 3-month follow-up period, whereas CTRL participants were offered an open label taper before completing the follow-up.

Results

Among those who completed one of the blinded tapering protocols, 92.9% totally discontinued their medication use by the end of the 20-week tapering phase, whereas 77.3% in the CTRL group discontinued hypnotic use by the end of their open label tapering. At follow-up 72.1% of those who completed blinded tapering remained medication free whereas only 52% of those who underwent open-label tapering remained medication free. Comparisons at follow-up showed those who received the open-label taper continued to use hypnotics on average 2.06 nights/week compared to .051 times per week for the blinded taper group (p = .042). The average weekly diazepam equivalent dose of medication used by the open label tapering group was 11.29 mg whereas the weekly dose for the blinded tapering group was 3.22 (p = .069).

Conclusion

CBTI combined with blinded hypnotic tapering is a promising treatment approach for helping hypnotic users overcome their medication dependence.

Support (if any)

National Institute of Drug Abuse, Grant # R34 DA042329-01
365 Cognitive Behavioral Therapy and Light Dark Therapy for Postpartum Insomnia Symptoms: Findings from a Randomized Controlled Trial
Authors: Verma Sumedha , Quin Nina , Astbury Laura , Wellecke Cornelia , Wiley Joshua , Davey Margot , Rajaratnam Shantha , Bei Bei
Published: May 2021

Introduction

Symptoms of insomnia are common in the postpartum period and are associated with a range of negative outcomes. Despite this, interventions to improve maternal postpartum sleep remain scarce. Cognitive Behavioral Therapy (CBT) and Light Dark Therapy (LDT) target two different mechanisms to reduce sleep disturbance. This randomized controlled trial examined the efficacy of CBT and LDT against a treatment-as-usual (TAU) condition in reducing maternal postpartum insomnia symptoms.

Methods

Nulliparous women 4–12 months postpartum with self-reported symptoms of insomnia (Insomnia Severity Index scores [ISI] >7) were included; excluded were those with: current severe health/psychiatric conditions, unsettled infant behaviors, sleep-affecting medication use and photosensitivity. Eligible women were randomized 1:1:1 to 6 weeks of CBT (CBT for insomnia and fatigue), LDT (morning bright light therapy, evening light hygiene), or TAU. Interventions were therapist-assisted and personalized through two telephone calls and included automated self-help intervention materials (i.e., emails) delivered over six weeks. Symptoms of insomnia (ISI; primary outcome), fatigue, sleepiness, depression, and anxiety were assessed at baseline, mid-intervention, post-intervention, and 1-month post-intervention. Analyses were intention-to-treat latent growth models.

Results

114 women were randomized (mean age = 32.20 ± 4.62 years) and 108 women completed the intervention. Compared to TAU, symptoms of insomnia significantly reduced from baseline to post-intervention in both CBT and LDT groups (p-values <.001), with very large effect sizes (d > 1.5) at post-intervention; gains were maintained at follow-up. Fatigue symptoms significantly reduced in the CBT group (p<.0001; d = 0.85) but not LDT (p = 0.11) compared to TAU at post-intervention; gains were maintained for CBT at follow-up. Group differences in sleepiness, depression, and anxiety were nonsignificant (all p > 0.08).

Conclusion

Therapist-assisted self-help CBT and LDT with different therapeutic mechanisms are both efficacious for reducing maternal insomnia symptoms during the postpartum period. Findings were mixed for fatigue, sleepiness and mood. Future research on predictors of treatment responses is needed.

Support (if any)

Australian National Health and Medical Research Council, Department of Education RTP Scholarship. Lucimed SA supplied light therapy glasses. Funders had no role in design/implementation of the trial. ANZCTR: ACTRN12618000842268.
366 Predictors of Dropout in University Students Participating in an 8-week E-mail Based Cognitive Behavioral Therapy for Insomnia
Authors: Nam Hyojin , Chang Jinyoung , Manber Rachel , Trockel Mickey , Okajima Isa , Yang Chien-Ming , Li Shirley , Suh Sooyeon
Published: May 2021

Introduction

As dropout from treatment potentially diminishes its therapeutic effect and poses clinical concern, it is important to find out which characteristics of participants are suitable for online-based treatment. Therefore, we aimed to identify factors that predicted a dropout in the e-mail based cognitive behavioral therapy (REFRESH) developed by Stanford University for the purpose of psychological intervention for insomnia.

Methods

Participants who participated in the REFRESH program consisted of 158 university and graduate students aged 18 to 30 in Hong Kong and Korea who scored higher than 10 on the Insomnia Severity Index (ISI), and the intervention was delivered in 8 weekly sessions sent via weekly e-mails. Among them, 110 were women (70%) and the average age was 22 (±2.71) years old. All participants were asked to answer the following self-reporting questionnaires before and after the intervention: Insomnia Severity Index; ISI, Depression Anxiety Stress Scale 21; DASS-21, Sleep Hygiene Practice Scale; SHPS, Dysfunctional Beliefs and Attitude about Sleep 16; DBAS-16. Descriptive statistics and ROC decision tree analysis were conducted to address our aim.

Results

Of the 158 participants, 68 completed the program, and 90 participants (57%) dropped out. The best predictor of dropout was DASS score with an optimal cup-point of <34. Of the 107 participants who reported DASS <30, 70(65.4%) dropped out. In contrast, of the 50 participants who reported DASS ≥34, 12(38%) dropped out. The second-level predictor was expectations for sleep score with a cut-point of <18. Among participants with DASS <34 and expectations for sleep score <18, 57(73.1%) dropped out. Of the 29 participants who reported DASS <34 and expectations for sleep score ≥18, 13(44.8%) dropped out.

Conclusion

Mild levels of depression, anxiety and stress and expectations for sleep appear to be predictive of dropout in an e-mail based intervention. People with mild symptoms may experience less distress and impairment, which may result in lower motivation to receive treatment. This may lead to inability to complete treatment and higher rates of dropout.

Support (if any):
367 A sleep hygiene and relaxation training program after the Great East Japan Earthquake: What aspects of sleep could be improved?
Authors: Sato Toshihiko , Ambo Hideo
Published: May 2021

Introduction

After a natural disaster, the incidence of sleep difficulties tends to increase. Specifically, the prevalence of suspected insomnia was reported to have increased among disaster victims after the Great East Japan Earthquake of March 11, 2011. In a previous study, we have reported that education on sleep hygiene and relaxation training was effective in improving nighttime sleep in students of universities in Sendai city after the earthquake of March 2011. According to analyses of subscale scores of the Pittsburgh Sleep Quality Index (PSQI), the present study aimed to determine what aspects of sleep difficulties were successfully improved.

Methods

University undergraduates and graduates who reported having sleep difficulties were asked to respond to a questionnaire including the PSQI thrice, before attending a 90-min lecture on sleep hygiene and relaxation training, and a month and three months after attending the program. All participants who reported the total PSQI score of the cutoff point (6) or more were divided into two groups based on their PSQI scores before the program, that attending the course and that not attending it, that is, the “waiting list” group.

Results

The “attending” group exhibited a decrease in the total PSQI score in the first month after attending the program, and the score in this group reduced further three months later; Nine of twenty (45.0%) attending participants reported the score of less than 6 after a month, while only three of seventeen (17.6%) wait-list participants did. The PSQI subscale scores reported by the nine successful attending participants indicated a significant decrease in the subscale scores on subjective sleep quality, sleep latency, sleep duration, and sleep disturbance from before the program to one month later.

Conclusion

These results suggest that the short course on sleep hygiene and relaxation training intended for university students was effective, and about a half of the attended participants reported the PSQI score of less than the PSQI cutoff score one month later. This substantial effect would be mainly based on the improvement of their subjective sleep quality, latency, duration, and disturbance.

Support (if any)

This study was supported by a research grant from the Japanese Psychological Association, Tokyo, Japan.
369 Insomnia with objective short sleep duration is associated with increased cortisol in patients with Mild Cognitive Impairment
Authors: Vgontzas Alexandros , Basta Maria , Li Yun , Fernandez-Mendoza Julio , Zaganas Ioannis , Panagiotakis Symeon , Simos Panagiotis
Published: May 2021

Introduction

Mild cognitive impairment (MCI) is frequent in the elderly and is in a continuum with dementia in a significant amount of people. Both insomnia and increased cortisol levels have been suggested as risk factors for MCI. The goal of this study was to examine whether activation of the hypothalamic-pituitary-adrenal (HPA) axis, as measured by plasma cortisol levels, is associated with the insomnia with short sleep duration (ISS) phenotype, as measured by actigraphy, in elderly with MCI.

Methods

A sub-sample of 109 subjects with MCI and 92 cognitively non-impaired controls 60 years or older (75.37±6.54y) was recruited from a population-based cohort residing on Crete, Greece. Subjects underwent medical history, physical examination, neuropsychiatric evaluation, neuropsychological testing, 3-day 24-h actigraphy, assessment of subjective insomnia symptoms (i.e., difficulties initiating and/or maintaining sleep), and a morning blood draw to assay for plasma cortisol levels. The ISS phenotype was defined by the presence of at least one insomnia symptom and an actigraphy-measured sleep efficiency below the median of the entire sample (i.e., ≤81%). Group differences in plasma cortisol levels between MCI subjects with and without the ISS phenotype were tested using ANCOVA adjusting for age, gender, BMI and depression.

Results

Subjects with MCI had higher cortisol levels compared to controls (105.34±9.34 vs. 70.3±10.02 nmol/L, p<0.05). Subjects with MCI and the ISS phenotype (138.38±16.57 nmol/L) had significantly higher cortisol levels compared to those without insomnia (97.74±19.68 nmol/L) or those with insomnia and normal sleep duration (INS; 79.97±16.02 nmol/L, p=0.044). The association between the ISS phenotype and cortisol levels was modified by amnestic symptoms (p-interaction=0.079); commensurate, the ISS phenotype was associated with higher cortisol levels among the amnestic MCI subgroup (INS: 79.12±21.93 vs. ISS: 155.55±20.40 nmol/L, p=0.040), but not among the non-amnestic MCI subgroup (INS: 64.06±23.62 vs. ISS: 89.33±29.00 nmol/L, p=0.559).

Conclusion

The ISS phenotype is associated with increased cortisol levels in elderly with MCI, particularly those with amnestic type. Improving sleep quality, decreasing cortisol levels and lengthening sleep duration may slow down the progression of these individuals into dementia.

Support (if any)

National Strategic Reference Framework(NSRF), Program: THALES entitled “UOC-Multidisciplinary network for the study of Alzheimer’s Disease” Grant Cod:MIS 377299
373 Historical Use of Substances for Insomnia Impacts Current Beliefs about Hypnotic Medications
Authors: Dietch Jessica , Simpson Norah , Tutek Joshua , Tully Isabelle , Rangel Elizabeth , Manber Rachel
Published: May 2021

Introduction

The purpose of the current study was to examine the relationship between current beliefs about hypnotic medications and historical use of prescription hypnotic medications or non-prescription substances for sleep (i.e., over the counter [OTC] medications, alcohol, and cannabis).

Methods

Participants were 142 middle age and older adults with insomnia (M age = 62.9 [SD = 8.1]; 71.1% female) enrolled in the RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING) study. Participants reported on history of substances they have tried for insomnia and completed the Beliefs about Medications Questionnaire-Specific with two subscales assessing beliefs about 1) the necessity for hypnotics, and 2) concerns about potential adverse consequences of hypnotics. Participants were grouped based on whether they had used no substances for sleep (No Subs, 11.6%), only prescription medications (Rx Only, 9.5%), only non-prescription substances (NonRx Only, 26.6%), or both prescription and non-prescription substances (Both, 52.3%).

Results

Sixty-one percent of the sample had used prescription medication for sleep and 79% had used non-prescription substances (74% OTC medication, 23% alcohol, 34% cannabis). The greater number of historical substances endorsed, the stronger the beliefs about necessity of hypnotics, F(1,140)=23.3, p<.001, but not about concerns. Substance groups differed significantly on necessity beliefs, F(3,1)=10.68, p<.001; post-hocs revealed the Both group had stronger beliefs than the No and NonRx Only groups. Substance groups also differed significantly on the concerns subscale, F(3,1)=6.68, p<.001; post-hocs revealed the NonRx Only group had stronger harm beliefs than the other three groups.

Conclusion

The majority of the sample had used both prescription and non-prescription substances to treat insomnia. Historical use of substances for treating insomnia was associated with current beliefs about hypnotics. Individuals who had used both prescription and non-prescription substances for sleep in the past had stronger beliefs about needing hypnotics to sleep at present, which may reflect a pattern of multiple treatment failures. Individuals who had only tried non-prescription substances for sleep may have specifically sought alternative substances due to concerns about using hypnotics. Future research should seek to understand the impact of treatment history on engagement in and benefit from non-medication-based treatment for insomnia.

Support (if any)

1R01AG057500; 2T32MH019938-26A1
376 dCBT-I with Chatbot and Artificial Intelligence: a feasibility study in Brazil
Authors: Castro Laura , Baraças Lucas , Hashioka Guilherme , Carvalho Adriana
Published: May 2021

Introduction

Digital cognitive-behavioral therapies for insomnia (dCBT-I) provide low-cost, evidence-based technology, effective in improving mental health and reducing healthcare costs. However, dropout rates still challenge dCBT-I scalability. Moreover, few solutions are available in middle-and-low-income economies where they are most needed. Our goal was to investigate feasibility, describing real-world data and preliminary findings of a novel, fully automated program, developed by Vigilantes do Sono (Sleep Watchers) using Chatbot and Artificial Intelligence (AI).

Methods

A digital coach interacts with users daily for 5–10 minutes, asking them to complete tailored diaries and delivering CBT-I knowledge pills in ~50 sessions, during ~7 weeks. The Insomnia Severity Index (ISI) is used before and after sleep restriction cycles, weekly revised by an algorithm. Participants (18+ years) were recruited (Jan-Oct/2020) through advertisements on social media, organic search, or were referred by health-care professionals, without face-to-face evaluation. All electronically signed an informed consent. We estimated engagement dividing number of complete diaries by number of days in the program. Generalized Estimating Equations (GEE) evaluated changes in sleep parameters, adjusting for baseline characteristics.

Results

Of 3,887 individuals who completed initial assessment, 3,139 (81%) had insomnia (ISI ≥11) and 1,489 (42±11 years, 91% women) fulfilled 7+ diaries, commenced sleep restriction, and were included in analysis. Of them, 604 (41%) completed a second ISI and 326 (22%) finished the program. GEE analyzing 42,802 diaries showed sleep duration increased 16.8 (11.9–21.6) minutes from first to second week and 67.3 (52.8–81.8) after week seven; parallel to a relative increase of 34% in sleep efficiency among women and 26% among men. Of 296 participants who reached therapeutic response (ISI reduction ≥8), 66% completed all sessions and 34% crossed half-way. Insomnia remission (ISI≤7) was seen for 55% and 33% of those with subthreshold (n=171) or clinical (n=419) baseline insomnia, respectively. Median (interquartile) engagement was 86% (65–98) and 90% of users recommend the program.

Conclusion

Chatbot and AI provide a framework to customize dCBT-I and personalize insomnia therapy, potentially favoring engagement and effectiveness. Our findings demonstrate feasibility of the program and support moving forward to continued development and testing the effects in clinical trials.

Support (if any):
378 Use of a Clinician’s Global Impression of Severity scale to measure insomnia severity in Alzheimer’s disease-dementia patients
Authors: Saretsky Todd , Ceesay Paulette , Zhong Wenjun , Herring W Joseph , Lines Christopher , Qureshi Zaina
Published: May 2021

Introduction

Full montage polysomnography (PSG) is the gold standard for the objective evaluation of sleep but is time consuming and inaccessible to most clinicians. A Clinician’s Global Impression of Severity (CGI-S) scale can be used in clinical practice to provide a subjective assessment of patients’ insomnia severity. However, the utility of a CGI-S scale for assessing insomnia in patients with Alzheimer’s disease (AD)-dementia is not well understood. In a recent Phase III randomized, placebo-controlled clinical trial (NCT02750306), patients on suvorexant with AD-dementia and insomnia showed improvements in both PSG total sleep time (TST) and CGI-S scores. We conducted additional analyses to examine the association between CGI-S and PSG-TST to inform on the possible use of a CGI-S scale to assess insomnia severity in patients with AD-dementia in real-world settings.

Methods

Patients (N=285) met clinical diagnostic criteria for both probable mild-to-moderate AD-dementia and insomnia. The primary endpoint was change-from-baseline in overnight PSG-TST at Week-4. A single-item CGI-S rating of insomnia with responses of 1 (normal, not ill at all) to 7 (among the most extremely ill patients) was completed by a trained rater at baseline and after 2 and 4 weeks. CGI-S was an exploratory endpoint. Post-hoc correlational analyses and analyses of distribution of change-from-baseline to Week-4 in CGI-S response categories were performed.

Results

Pearson correlation indicated a significant association at baseline between PSG-TST and CGI-S (r=-0.18, nominal p=0.004). A correlation of change-from-baseline to Week-4 also indicated an association between PSG-TST and CGI-S (r=-0.24, nominal p<.0001). The distribution of change in CGI-S response category results at Week-4 showed that, compared to placebo, numerically less patients on suvorexant remained stable or worsened by >1 response category (21.8% vs. 29.4%, respectively) and numerically more improved by ≥1 response category (73.3% vs. 67.9%, respectively).

Conclusion

Our findings suggest that a CGI-S scale may be a useful tool for assessing insomnia severity in mild-to-moderate AD-dementia patients. Future studies with these patients are needed to determine the utility of a CGI-S scale in real-world settings.

Support (if any)

This study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
385 Subjective-objective sleep discrepancy and quality of life in self-reported insomnia and sleep apnea
Authors: Ma Yan , Goldstein Michael , Davis Roger , Yeh Gloria
Published: May 2021

Introduction

Current diagnostic classifications define insomnia based on self-reported sleep difficulties. However, differences between self-reported and objectively measured sleep parameters (subjective-objective sleep discrepancy or sleep misperception) are very common. Insomnia and sleep apnea cause common impairments that overlap and have negative impacts on overall health. Previous studies have encouraged an in-depth understanding of subjective-objective sleep discrepancy to inform a role for behavioral, mind-body approaches to insomnia. In this study, utilizing patients with insomnia and comorbid sleep apnea, we aimed to understand associations between self-reported insomnia, sleep difficulties, sleep misperception and quality-of-life.

Methods

We conducted a secondary analysis using data from the Sleep Heart Health Study (a multi-site nationally representative sample) to examine the profile of subjective and objective sleep measures in people with insomnia (IS, n=73) and comorbid sleep apnea (IS+SA, n=143), compared to individuals with sleep apnea only (SA, n=296) and normal sleep controls (NSC, n=126). We also compared the magnitude of sleep misperception between these four groups and examined the corresponding impact of subjective insomnia complaints on quality-of-life.

Results

Sleep discrepancy was found in all four groups. After controlling for age, sex, mental health conditions, sleep apnea severity, and objectively measured sleep time, the presence of self-reported insomnia had the strongest association with sleep discrepancy on total sleep time (TST, β=-34.4, p<0.001) and sleep onset latency (SOL, β=14.7, p<0.001). Subjects who reported no difficulty falling asleep slightly underestimated their sleep onset latency, while those who reported difficulty substantially overestimated sleep latency. Self-reported insomnia had a significantly negative impact on the quality of life in both physical and mental components (p<0.001).

Conclusion

Sleep discrepancy exists in normal controls, insomnia, and sleep apnea. Subjects with self-reported insomnia have a higher degree of sleep misperception. Both sleep apnea and self-reported insomnia are associated with negative QOL. Those with comorbid sleep apnea report the greatest sleep discrepancy and lowest QOL. Further research is needed to better understand individual profiles of misperception and insomnia phenotypes, apnea comorbidity and quality-of-life. Behavioral, mind-body interventions may offer strategies to address mental stress, sleep misperception, and insomnia.

Support (if any)

NCCIH T32AT000051 and NHLBI 5T32HL007901-22
390 Risk of Obstructive Sleep Apnea: A Comparison Between Ischemic and Hemorrhagic Stroke
Authors: Griesbach Grace , Robinson Stephanie , Howell Stefanie
Published: May 2021

Introduction

Obstructive Sleep Apnea (OSA) is common amongst stroke patients. Distinction between the prevalent types of stroke when evaluating sleep may prove useful to prevent recurrent strokes. There is a lack of information on how apnea prevalence following ischemic stroke compares to hemorrhagic stroke, particularly during the chronic period. Here we set out to retrospectively determine if apnea incidence was more marked in ischemic stroke patients compared to those that received a hemorrhagic stroke diagnose; while taking in account medications taken during the sleep evaluation.

Methods

Medical records were reviewed from 103 patients diagnosed with stroke that underwent a type I fully attended overnight polysomnography. Diagnosis of embolic, thromboembolic or hemorrhagic stroke was obtained from a neurological report that was typically confirmed by computed tomography or magnetic resonance imaging. Medications that the subject was taking at the time of the sleep study were documented by the sleep technologist.

Results

Arousals and microarousal index was higher in the ischemic group (p<0.005). Age adjusted assessment of apnea and hypopnea events, indicated that subjects with an ischemic stroke had a higher incidence of apnea and hypopnea compared to the hemorrhagic group (p<0.005). Ischemic subjects were also more likely to present severe apnea (AHI > 30) (p<0.005). In comparison, a higher percentage of hemorrhagic subjects had an AHI below 5 (p<0.005). Type of hemorrhagic stroke did not have an impact on apnea/hypopnea variables. Those with an ischemic stroke were taking significantly more lipid lowering agents (p<0.05). Logistic regression analysis indicated that the predictive probability of apnea (AHI > 5) increased from 0.55 to 0.81 (p < 0.05) when anti-hypertensive use was considered. An increase in predictive values for apnea was observed for indicators of diabetes such as use of anti-diabetics with or without consideration of diabetic history (p < 0.05).

Conclusion

Data suggests that ischemic patients present a higher artherosclerotic load that may contribute to the higher incidence of severe OSA. These data indicate that it is relevant to consider stroke type when determining the risk of OSA thus facilitating new strategies for stroke recurrence prevention.

Support (if any):
391 Upper Airway Resistance Syndrome is associated with high Cyclic Alternating Pattern
Authors: Godoy Luciana , Soster Letícia , Bueno Clarissa , Togeiro Sonia , Poyares Dalva , Tufik Sergio , Palombini Luciana
Published: May 2021

Introduction

Upper Airway Resistance Syndrome (UARS) is suspected in individuals with excessive daytime sleepiness, fatigue, and sleep fragmentation associated with increased respiratory effort. UARS can negatively impact daytime function. Conventional polysomnography parameters do not demonstrate significant abnormalities in UARS patients but increase in RERAs and arousal index. Cyclic alternating pattern (CAP) is a periodic electroencephalogram activity of non-REM sleep that expresses a condition of sleep instability. The objective of the study was to compare CAP components between UARS patients and health individuals.

Methods

Fifteen subjects with UARS and 15 age- and sex- matched controls had their sleep study blinded analyzed. UARS criteria were the presence of sleepiness (Epworth Sleepiness Scale – ESS - ≥ 10) and/or fatigue (Modified Fatigue Impact Scale ≥ 38) associated with an apnea/hypopnea index (AHI) ≤ 5 and a respiratory disturbance index (RDI) > 5 events/hour of sleep, and/or flow limitation in more than 30% of total sleep time. Control group criteria were AHI < 5 events/hour, RDI ≤ 5 events/hour and < 30% of TST with flow limitation and ESS < 10, without sleep, clinical, neurological, or psychiatric disorder. CAP electroencephalogram of both groups was analyzed.

Results

We found higher CAP rate (p = 0.05) and CAP index in N1 stage (p < 0.001) and in N3 stage (p < 0.001) in UARS patients compared to control group. Considering only CAP phase A1 analysis, UARS patients presented higher CAP rate (p = 0.05) and CAP index in N1 stage (p < 0.001) as well as CAP index in N3 stage (p < 0.001) compared to control group. Considering only CAP phase A2 analysis, UARS patients also presented higher number of CAP in N1 stage (p = 0.05). There was no significant difference for CAP phase A3 between groups.

Conclusion

Although UARS is associated with high arousal index, we found increase in CAP phase A1 and A2, which do not include necessarily AASM arousals, suggesting not only sleep fragmentation but also sleep instability.

Support (if any)

Associação Fundo de Incentivo à Pesquisa (AFIP) and Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP).
395 Exercise Capacity is Maintained in Older Military Personnel with Moderate to Severe Obstructive Sleep Apnea
Authors: Arora Subodh , Powell Tyler , Foster Shannon , Hansen Shana , Morris Michael
Published: May 2021

Introduction

The relationship between moderate to severe OSA and exercise capacity remains unclear. Prior studies showing a reduction in VO2 max in this population have mostly involved middle-aged and overweight patients. We looked to determine if this trend in VO2 max was present in a similarly aged population of military personnel with previously undiagnosed moderate to severe OSA.

Methods

We studied 170 middle-aged male military members who underwent cardiopulmonary exercise testing (CPET) and polysomnography (PSG) as a part of a comprehensive evaluation for an established military program. For analysis, patients were categorized either into an OSA group (apnea-hypopnea index (AHI) ≥ 15 events/h) or control group (AHI < 15 events/h). VO2 max was compared between groups.

Results

Mean AHI was 29.0 in the OSA group (n =58) versus 7.4 in the controls (n = 112). Patients were of similar age (53.1 vs. 53.7 years) and BMI was slightly higher in the OSA group (27.5kg/m2 versus 26.3 kg/m2, P = .0077). Percent-predicted VO2 max was supernormal in both groups, though was comparatively lower in the OSA group (117% vs. 125%; P <.001). There was a trend toward a blunted heart rate response to exercise in the OSA group as represented by peak heart rate (163 vs. 178; p=0.07).

Conclusion

Older military personnel with moderate to severe OSA have normal exercise capacity. This may suggest that the low-arousal OSA phenotype often noted in military personnel does not significantly influence exercise capacity or that regular exercise helps limit its impact. It remains likely that the effect of untreated OSA on exercise capacity is influenced by several variables including age, BMI, OSA phenotype, and regularity of exercise. Trends in VO2 max and peak heart rate noted in this study may suggest that untreated OSA in certain populations can negatively impact exercise capacity

Support (if any)

No external funding
399 Using Machine Learning to Inform Extraction of Clinical Data from Sleep Study Reports
Authors: Mazzotti Diego , Staley Bethany , Keenan Brendan , Pack Allan , Schwab Richard , Boland Mary Regina
Published: May 2021

Introduction

In-laboratory and home sleep studies are important tools for diagnosing sleep disorders. However, a limited amount of measurements is used to inform disease severity and only specific measures, if any, are stored as structured fields into electronic health records (EHR). We propose a sleep study data extraction approach based on supervised machine learning to facilitate the development of specialized format-specific parsers for large-scale automated sleep data extraction.

Methods

Using retrospective data from the Penn Medicine Sleep Center, we identified 64,100 sleep study reports stored in Microsoft Word documents of varying formats, recorded from 2001–2018. A random sample of 200 reports was selected for manual annotation of formats (e.g., layout) and type (e.g. baseline, split-night, home sleep apnea tests). Using text mining tools, we extracted 71 document property features (e.g., section dimensions, paragraph and table elements, regular expression matches). We identified 14 different formats and 7 study types. We used these manual annotations as multiclass outcomes in a random forest classifier to evaluate prediction of sleep study format and type using document property features. Out-of-bag (OOB) error rates and multiclass area under the receiver operating curve (mAUC) were estimated to evaluate training and testing performance of each model.

Results

We successfully predicted sleep study format and type using random forest classifiers. Training OOB error rate was 5.6% for study format and 8.1% for study type. When evaluating these models in independent testing data, the mAUC for classification of study format was 0.85 and for study type was 1.00. When applied to the large universe of diagnostic sleep study reports, we successfully extracted hundreds of discrete fields in 38,252 reports representing 33,696 unique patients.

Conclusion

We accurately classified a sample of sleep study reports according to their format and type, using a random forest multiclass classification method. This informed the development and successful deployment of custom data extraction tools for sleep study reports. The ability to leverage these data can improve understanding of sleep disorders in the clinical setting and facilitate implementation of large-scale research studies within the EHR.

Support (if any)

American Heart Association (20CDA35310360).
400 Utility of the STOP Questionnaire in Predicting Sleep Disordered Breathing in Older Women Veterans
Authors: Kelly Monica , Moghtaderi Isabel , McGowan Sarah Kate , Carlson Gwendolyn , Josephson Karen , Mitchell Michael , Swistun Dominika , Fung Constance , Zeidler Michelle , Badr Safwan , Martin Jennifer
Published: May 2021

Introduction

Sleep disordered breathing (SDB) is underdiagnosed in older women, despite a significant increase in SDB prevalence post-menopause. Few studies have assessed the diagnostic accuracy of SDB screening questionnaires in older women, particularly older Women Veterans (WV). WV have higher rates of SDB compared to non-Veteran women and are particularly vulnerable to sleep disorders in general. We examined the diagnostic accuracy of the STOP questionnaire compared to home sleep apnea testing (HSAT) that includes sleep time estimation (i.e., WatchPAT) in older WV.

Methods

Cross-sectional baseline data obtained from chart review were combined from two behavioral sleep intervention studies targeting WV with sleep difficulties (i.e., insomnia symptoms) or SDB risk factors (e.g., hypertension, obesity). A total of 136 older WV (50-91y; age=60.0±7.8y) completed the STOP questionnaire (yes/no: snoring, tiredness, observed breathing pauses, and high blood pressure [BP]) and had an apnea-hypopnea index (AHI) available from their baseline HSAT (WatchPAT). Sensitivity, specificity, and positive and negative likelihood ratios (+LR/-LR) were calculated to characterize the diagnostic accuracy of STOP≥2 for AHI≥5 (mild SDB) or AHI≥15 (moderate SDB).

Results

70.6% (n=96) of participants endorsed a STOP≥2, 83.8% (n=114) demonstrated an AHI≥5 and 46.3% (n=63) demonstrated an AHI≥15. For AHI≥5, sensitivity was 73.7% (95% CI=64.6,81.5%), specificity was 45.5% (95% CI=24.4,67.8%), +LR was 1.35 (95% CI=0.91, 2.01), and -LR was 0.58 (95% CI=0.33,1.00). For AHI≥15, sensitivity was 76.2% (95% CI=63.8,86%), specificity was 34.2% (95% CI=23.5,46.3%), +LR was 1.16 (95% CI=0.93,1.44), and -LR was 0.70 (95% CI=0.30,1.20).

Conclusion

The likelihood ratios for STOP≥2 limited the utility of the STOP vs. an HSAT system with sleep scoring in determining AHI. While the STOP correctly identified 3/4 of older WV with SDB on WatchPAT, it correctly identified <50% of older WV without SDB. Screening measures that better capture predictors of moderate SDB in women at risk for SDB are needed, especially in older women who may not present clinically with the common SDB symptoms (i.e. snoring, tiredness, observed breathing pauses, and high BP). STOP compared to polysomnography studies are also needed.

Support (if any)

VA HSR&D IIR-13–058, IIR 16–244 and RCS 20–191; NIH/NHLBI K24 HL143055, VAGLAHS GRECC, VA Office of Academic Affiliations, and AASM Foundation.
404 Sleep-Disordered Breathing In Native Hawaiians/Pacific Islanders With Associated Comorbidities And Adherence To Therapy
Authors: Ryujin Darin , Sundar Krishna , Gilles Allyson
Published: May 2021

Introduction

Sleep-disordered breathing in Native Hawaiians and Pacific Islanders (NHPIs), its relationship to type 2 diabetes mellitus (DM), chronic renal, and heart disease, is not well known. NHPIs comprise only 1.3% of Utah’s population, but have the highest rates of DM and deaths due to diabetic kidney disease in Utah. This study assessed the nature of sleep-disordered breathing, its association with demographic variables, and comorbidities, and adherence patterns to positive airway pressure (PAP) therapy.

Methods

University of Utah sleep clinics patient databases from 2014 were evaluated to identify NHPIs using first/last names. Electronic medical records were reviewed to confirm patient ethnic origin, demographic data, and comorbidities. The most recent PAP downloads were obtained.

Results

Of 106 NHPIs were identified, data available for 104 patients (71 males, 33 females) was analyzed. Mean age of males was 47 + 13 years and females 48±13 years. Prevalence rates of obesity were 13% (female 9%, male 15%) with BMI≥30, 33% (female 24%, male 23%) with BMI≥35, and 49% (female 58%, Male 23%) with BMI≥40). Majority of patients had severe OSA (61% males with AHI≥30; 39% females with ≥ 30), with overall mean AHI of 47±38. A high prevalence of comorbidities was noted: 61% hypertension (male 58%; female 67%), diabetes 54% (male 48%, female 67%), renal disease 20% (male 21%, female 18%), coronary artery disease 13% (male 14%, female 9%), and congestive heart failure 13% (male 15%, female 9%). Prevalence of lung disease was low 13% (male 9%, female 18%).

Conclusion

NHPIs evaluated for sleep-disordered breathing have high rates of obesity, severe OSA, and concerning comorbidities. PAP adherence in this group was poor compared to overall adherence for patients seen in University of Utah sleep clinics (~70%). Further research is required to assess the relationships between OSA, associated comorbidities, and disease outcomes. Addressing low rates of PAP adherence in this population may afford opportunities to improve health outcomes.

Support (if any)

n/a
406 Clinical Validation of AI Scoring in Adult and Pediatric Clinical PSG Samples Compared to Prospective, Double-Blind Scoring Panel
Authors: Fernandez Chris , Rusk Sam , Glattard Nick , Nygate Yoav , Turkington Fred , Watson Nathaniel
Published: May 2021

Introduction

Despite an appreciable rise in sleep wellness and sleep medicine A.I. research publications, public data corpuses, institutional support, and health A.I. research funding opportunities, the availability of controlled-retrospective, hybrid-retrospective-prospective, and prospective-RCT quality clinical validation study evidence is limited with respect to their potential clinical impact. Furthermore, only a few practical examples of A.I. technologies are validated, in use today clinically, and widely adopted, to assist in sleep diagnoses and treatment. In this study, we contribute to this growing body of clinical A.I. validation evidence and experimental design methodologies with an interoperable A.I. scoring engine in Adult and Pediatric populations.

Methods

Stratified random sampling with proportionate allocation was applied to a database of N>10,000 retrospective diagnostic clinical polysomnography (PSG), selected by evidence grading standards, with controls applied for OSA severity, diagnoses; sleep, psychiatric, neurologic, neurodevelopmental, cardiac, pulmonary, metabolic disorders, medications; benzodiazepines, antidepressants, stimulants, opiates, sleep aids, demographic groups of interest; sex, adult age, pediatric age, BMI, weight, height, and patient-reported sleepiness, to establish representative N=100 Adult and N=100 Pediatric samples. Double Blinded scoring was prospectively collected for each sample by 3 experienced RPSGT certified sleep technologists randomized from a pool of 9 scorers. Sensitivity (PA), Specificity (NA), Accuracy (OA), Kappa (K), and 95% Bootstrap CI’s are presented for sleep stages, OSA/CSA, hypopnea 3%/4%, arousals, limb movements, Cheyenne-Stokes respiration, periodic breathing, atrial fibrillation, and other events, and normative, mild, moderate, and severe OSA categories for global-AHI and REM-AHI. Results for Sleep Staging and OSA Severity Diagnostic Accuracy are summarized.

Results

A.I. scoring performance meet but in most cases exceeded initial clinical validation study (N=72 Adults, 2017) PA, NA, OA, K point-estimates and confidence-interval results for the 26 event types and 8 AHI-categories evaluated. The Adult sample showed 87%/94% Sensitivity/Specificity across all stages (Wake/N1/N2/N3/REM) and 94%/96% Sensitivity/Specificity for AHI>=15. The Pediatric sample showed 87%/93% Sensitivity/Specificity staging, 89%/98% Sensitivity/Specificity AHI>=15. Observed Accuracy was >90% for Adults and Pediatrics all 26 events and 7 AHI-categories analyzed, except REM-AHI>=5 (85%/82% Adults/Pediatrics).

Conclusion

We provide clinical validation evidence that demonstrates interoperable A.I. scoring performance in representative Adult and Pediatric patient clinical PSG samples when compared to prospective, double-blind scoring panel.

Support (if any):