Accrual and retention of diverse patients in psychosocial cancer clinical trials.

Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.

Detection of Common Arrhythmias by the Watch-PAT: Expression of Electrical Arrhythmias by Pulse Recording.

Background: The WatchPAT (WP) device was shown to be accurate for the diagnosis of sleep apnea and is widely used worldwide as an ambulatory diagnostic tool. While it records peripheral arterial tone (PAT) and not electrocardiogram (ECG), the ability of it to detect arrhythmias is unknown and was not studied previously. Common arrhythmias such as atrial fibrillation (AF) or premature beats may be uniquely presented while recording PAT/pulse wave. Purpose: To examine the potential detection of common arrhythmias by analyzing the PAT amplitude and pulse rate/volume changes. Patients and Methods: Patients with suspected sleep disordered breathing (SDB) were recruited with preference for patients with previously diagnosed AF or congestive heart failure (CHF). They underwent simultaneous WP and PSG studies in 11 sleep centers. A novel algorithm was developed to detect arrhythmias while measuring PAT and was tested on these patients. Manual scoring of ECG channel (recorded as part of the PSG) was blinded to the automatically analyzed WP data. Results: A total of 84 patients aged 57±16 (54 males) participated in this study. Their BMI was 30±5.7Kg/m2. Of them, 41 had heart failure (49%) and 17 (20%) had AF. The sensitivity and specificity of the WP to detect AF segments (of at least 60 seconds) were 0.77 and 0.99, respectively. The correlation between the WP derived detection of premature beats (events/min) to that of the PSG one was 0.98 (p<0.001). Conclusion: The novel automatic algorithm of the WP can reasonably detect AF and premature beats. We suggest that when the algorithm raises a flag for arrhythmia, the patients should shortly undergo ECG and/or Holter ECG study.

A transition to the American Academy of Sleep Medicine-recommended hypopnea definition in adults: initiatives of the Hypopnea Scoring Rule Task Force.

The American Academy of Sleep Medicine (AASM) recommends that hypopneas be identified using a definition that is based on a ≥ 30% decrease in airflow associated with a ≥ 3% reduction in the oxygen saturation or an arousal (H3A) for diagnosis of obstructive sleep apnea (OSA) in adults. This conflicts with the Centers for Medicare & Medicaid Services definition, which requires a ≥ 4% decrease in the oxygen saturation to identify a hypopnea (H4) and does not acknowledge arousals. In 2018, the AASM Board of Directors constituted a Hypopnea Scoring Rule Task Force with a mandate to "create a strategy for adoption and implementation of the AASM recommended adult hypopnea scoring criteria among members, payers and device manufacturers." The task force initiated several activities including a survey of AASM-accredited sleep facilities and discussions with polysomnography software vendors. Survey results indicated that most sleep facilities scored polysomnograms using only the Centers for Medicare & Medicaid Services definition. Vendors indicated that they could easily support dual scoring. Informal testing among task force members' sleep facilities confirmed there would be little additional work if dual scoring was performed. The task force convened several meetings of a working group of OSA content experts and interested parties, with the purpose of creating research recommendations to study the impact on relevant clinical outcomes using the different definitions of hypopnea. Several possible prospective and retrospective approaches were discussed with emphasis on the group of patients diagnosed with OSA based on an apnea-hypopnea index using H3A but not H4. Based on the deliberations of the working group, the Hypopnea Scoring Rule Task Force submitted recommendations to the AASM Foundation concerning research project strategies for potential grant funding. Further discussions within the Hypopnea Scoring Rule Task Force focused on developing advocacy initiatives among patient stakeholder groups to change payer policy. CITATION: Berry RB, Abreu AR, Krishnan V, Quan SF, Strollo PJ Jr, Malhotra RK. A transition to the American Academy of Sleep Medicine-recommended hypopnea definition in adults: initiatives of the Hypopnea Scoring Rule Task Force. J Clin Sleep Med. 2022;18(5):1419-1425.

Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study.

STUDY OBJECTIVES: To examine whether cognitive behavioral treatments for insomnia (CBT-I) and pain (CBT-P) lead to neural activation changes in response to pain in fibromyalgia. METHODS: Thirty-two patients with fibromyalgia (mean age = 55.9, standard deviation = 12.2) underwent an experimental pain protocol during functional magnetic resonance imaging and completed 14-day diaries assessing total wake time, total sleep time, and pain intensity before and after CBT-I, CBT-P, or waitlist control. Random effects analysis of covariance identified regions with significant group (CBT-I, CBT-P, waitlist control) by time (baseline, post-treatment) interactions in blood oxygen level-dependent response to pain. Linear regressions using residualized change scores examined how changes in total wake time, total sleep time, and pain intensity were related to activation (blood oxygen level-dependent) changes. RESULTS: Twelve regions exhibited small to moderate effects with significant interactions Ps < .00; right hemisphere: inferior frontal, middle occipital, and superior temporal gyri, insula, lentiform nucleus; left hemisphere: angular, superior temporal, midfrontal, inferior occipital, midtemporal, and inferior frontal gyri. Blood oxygen level-dependent response to pain decreased in 8 regions following CBT-I, and in 3 regions following CBT-P (CBT-I effects > CBT-P). Blood oxygen level-dependent response also increased in 3 regions following CBT-P and in 6 regions following waitlist control. Improved total wake time and/or total sleep time, not pain intensity, predicted decreased blood oxygen level-dependence in 7 regions (Ps < .05), accounting for 18%-47% of the variance. CONCLUSIONS: CBT-I prompted greater decreases in neural activation in response to pain across more regions associated with pain and sleep processing than CBT-P. Reported sleep improvements may underlie those decreases. Future research examining the longer-term impact of CBT-I and improved sleep on central pain and sleep mechanisms is warranted. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Sleep and Pain Interventions in Fibromyalgia (SPIN); Identifier: NCT02001077; URL: https://clinicaltrials.gov/ct2/show/NCT02001077. CITATION: McCrae CS, Craggs JG, Curtis AF, et al. Neural activation changes in response to pain following cognitive behavioral therapy for patients with comorbid fibromyalgia and insomnia: a pilot study. J Clin Sleep Med. 2022;18(1):203-215.

Impacts of Cognitive Behavioral Therapy for Insomnia and Pain on Sleep in Women with Gynecologic Malignancies: A Randomized Controlled Trial.

Insomnia is an adverse cancer outcome impacting mood, pain, quality of life, and mortality in cancer patients. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment for diverse psychophysiological disorders, including pain and insomnia. Primarily studied in breast cancer, there is limited research on CBT within gynecology oncology. This study examined CBT effects on subjective and behavioral sleep outcomes: Sleep Efficiency (SE), Sleep Quality (SQ), Total Wake Time (TWT), Sleep Onset Latency (SOL), and Wake After Sleep Onset (WASO). Thirty-five women with insomnia status/post-surgery for gynecologic cancer were randomized to CBT for insomnia and pain (CBTi.p., N = 18) or Psychoeducation (N = 17). Sleep was assessed via sleep diaries and wrist-worn actigraphy at baseline (T1), post-intervention (T2), and two-month follow-up (T3). Intent-to-treat analyses utilizing mixed linear modeling examined longitudinal group differences on sleep controlling for age and advanced cancer. All participants demonstrated improved (1) subjective SE (0.5, p < .01), SOL (-1.2, p < .01), TWT (-1.2, p < .01), and (2) behavioral SE (0.1, p = .02), TWT (-1.2, p = .03), WASO (-0.8, p < .01) across time. Group-level time trends were indicative of higher subjective SE (6.8, p = .02), lower TWT (-40.3, p = .01), and lower SOL (-13.0, p = .05) in CBTi.p. compared to Psychoeducation. Supplemental analyses examining clinical significance and acute treatment effects demonstrated clinical improvements in SE (T1), TWT (T2, T3), and SOL (T3). Remaining effects were not significant. Despite lacking power to detect interaction effects, CBTi.p. clinically improved sleep in women with gynecologic cancers and insomnia during the active treatment phase. Future research will focus on developing larger trials within underserved populations.

Optimal NIV Medicare Access Promotion: Patients With Central Sleep Apnea: A Technical Expert Panel Report From the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society.

This document summarizes suggestions of the central sleep apnea (CSA) Technical Expert Panel working group. This paper shares our vision for bringing the right device to the right patient at the right time. For patients with CSA, current coverage criteria do not align with guideline treatment recommendations. For example, CPAP and oxygen therapy are recommended but not covered for CSA. On the other hand, bilevel positive airway pressure (BPAP) without a backup rate may be a covered therapy for OSA, but it may worsen CSA. Narrow coverage criteria that require near elimination of obstructive breathing events on CPAP or BPAP in the spontaneous mode, even if at poorly tolerated pressure levels, may preclude therapy with BPAP with backup rate or adaptive servoventilation, even when those devices provide demonstrably better therapy. CSA is a dynamic disorder that may require different treatments over time, sometimes switching from one device to another; an example is switching from BPAP with backup rate to an adaptive servoventilation with automatic end-expiratory pressure adjustments, which may not be covered. To address these challenges, we suggest several changes to the coverage determinations, including: (1) a single simplified initial and continuing coverage definition of CSA that aligns with OSA; (2) removal of hypoventilation terminology from coverage criteria for CSA; (3) all effective therapies for CSA should be covered, including oxygen and all PAP devices with or without backup rates or servo-mechanisms; and (4) patients shown to have a suboptimal response to one PAP device should be allowed to add oxygen or change to another PAP device with different capabilities if shown to be effective with testing.

Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia.

Background: Cognitive behavioral therapy for insomnia (CBT-I) is underused in healthcare settings and is challenging for people with insomnia to access because of uneven geographical distribution of behavioral sleep medicine providers. Prescription digital therapeutics can overcome these barriers. This study evaluates the effectiveness of a specific digital CBT-I therapeutic. Materials & methods:Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM) is a 9-week, open-label, decentralized clinical trial to collect real-world evidence for a digital therapeutic (Somryst™) delivering CBT-I to patients with chronic insomnia. The primary objective is to examine the effectiveness of Somryst to reduce self-reported insomnia symptoms and severity in a real-world population (n = 350). Conclusion: This pragmatic study seeks to assess the potential benefits of treating insomnia with an asynchronous, mobile, tailored prescription digital therapeutic. Clinical trial registration: NCT04325464 (ClinicalTrials.gov).

Lay abstract Chronic insomnia is linked to a range of health problems, including heart disease, chronic pain, high blood pressure and depression. A behavioral treatment called cognitive behavioral therapy for insomnia (CBT-I) is considered the first choice for helping patients overcome insomnia and reduce their risks of insomnia-related problems. Although the benefits of CBT-I have been established, it can be difficult for patients to access trained CBT-I therapists. One possible solution is to use digital forms of CBT-I, which patients can access on mobile devices. Somryst™ is a prescription digital therapeutic, which means it is authorized by the US FDA and has been proven effective in carefully-controlled clinical trials. Less is known, however, about how well the prescription digital therapeutic works in real-world settings. The Digital Real-world Evidence trial for Adults with insomnia treated via Mobile study (DREAM) will explore this question by evaluating a range of symptoms and outcomes in at least 350 patients with chronic insomnia who will use Somryst and be followed for 1 year.

Knuckle cracking at night associated with sodium oxybate treatment.

NONE: During upward titration of a dose of sodium oxybate therapy for narcolepsy with cataplexy, a 25-year-old woman was observed by her husband to have new onset of knuckle-cracking and moaning behaviors during sleep ≥1 nights each week. The patient did previously occasionally crack her knuckles during the day (but never at night). These behaviors had not been evaluated by polysomnography. After transition of care, polysomnography with video monitoring was ordered and revealed 2 knuckle-cracking episodes that developed out of stage N2 sleep and were likely a non-rapid eye movement sleep parasomnia associated with sodium oxybate treatment.

Impact of a brief behavioral treatment for insomnia (BBTi) on metacognition in older adults.

INTRODUCTION: Brief (≤4 sessions) behavioral treatment for insomnia (BBTi) improves insomnia symptoms in older adults. Findings for BBTi-related improvements in objective cognition are mixed, with our recent trial reporting no effects. Metacognition (appraisal of one's own performance) has not been examined. This study examined the effects of BBTi on metacognition in older adults with insomnia. METHODS: Older adults with insomnia [N = 62, Mage = 69.45 (SD = 7.71)] were randomized to 4-weeks of BBTi (n = 32; psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n = 30; social conversations). Throughout the study (2 week baseline, 4 week treatment, 2 week post-treament, 2 week 3-month followup), participants completed daily paper/pencil cognitive tasks (measuring verbal memory, attention, processing speed and reasoning) and provided daily metacognition ratings of their performance in four areas: quality, satisfaction, compared to same age peers, compared to own ability. Two-week averages of metacognitive ratings were calculated for baseline, treatment-first half, treatment-second half, post-treatment, and 3-month follow-up. Multilevel Modeling examined treatment effects (BBTi/SMC) over time on metacognition, controlling for age and sex. RESULTS: A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi. Specifically, baseline ratings [mean (M) = 51.21, standard error (SE) = 3.15] improved at first half of treatment (M = 56.65, SE = 3.15, p < 0.001), maintained improvement at second-half of treatment (p = 0.18), showed additional improvement at post-treatment (M = 60.79, SE = 3.15, p = 0.02), and maintained improvement at follow-up (M = 62.30, SE = 3.15; p = 0.02). SMC prompted inconsistent and smaller improvements between baseline (M = 53.24, SE = 3.29) and first-half of treatment (M = 56.62, SE = 3.28; p = 0.004), with additional improvement at second-half of treatment (M = 59.39, SE = 3.28; p = 0.02) that was maintained at post-treatment (p = 0.73) and returned to levels observed at first-half of treatment (M = 57.78, SE = 3.21; p = 0.55). Significant main effects of time (all ps < 0.001) for other metacognition variables (Quality, Satisfaction, Compared to own ability) indicated general improvements over time for both groups. DISCUSSION: Metacognition generally improved over time regardless of treatment. BBTi selectively improved ratings of performance relative to same age peers. Repeated objective testing alone may improve metacognition in older adults with insomnia. Better understanding of metacognition and how to improve it has important implications for older adults as metacognitive complaints have been associated with mild cognitive impairment.

The Association Between Obstructive Sleep Apnea Defined by 3 Percent Oxygen Desaturation or Arousal Definition and Self-Reported Cardiovascular Disease in the Sleep Heart Health Study.

BACKGROUND: Studies have established that OSA defined using a hypopnea definition requiring a ≥4% oxygen desaturation (AHI4%) is associated with cardiovascular (CVD) or coronary heart (CHD) disease. This study determined whether OSA defined using a hypopnea definition characterized by a ≥3% oxygen desaturation or an arousal (AHI3%A) is associated with CVD/CHD. METHODS: Data were analyzed from 6307 Sleep Heart Health Study participants who had polysomnography. Self-reported CVD included angina, heart attack, heart failure, stroke, previous coronary bypass surgery or angioplasty. Self-reported CHD included the aforementioned conditions but not stroke or heart failure. The association between OSA and CVD/CHD was examined using logistic regression models with stepwise inclusion of demographic, anthropometric, social/behavioral and co-morbid medical conditions. A parsimonious model in which diabetes and hypertension were excluded because of their potential to be on the causal pathway between OSA and CVD/CHD also was constructed. RESULTS: For CVD, the odds ratios and 95% confidence intervals for AHI3%A ≥30/hour were 1.39 (1.03-1.87) and 1.45 (1.09-1.94) in the fully adjusted and parsimonious models. Results for CHD were 1.29 (0.96-1.74) and 1.36 (0.99-1.85). In participants without OSA according to more stringent AHI4% criteria but with OSA using the AHI3%A definition, similar findings were observed. CONCLUSION: OSA defined using an AHI3%A is associated with both CVD and CHD. Use of a more restrictive AHI4% definition will misidentify a large number of individuals with OSA who have CVD or CHD. These individuals may be denied access to therapy, potentially worsening their underlying CVD or CHD.

Incidence of hypertension in obstructive sleep apnea using hypopneas defined by 3 percent oxygen desaturation or arousal but not by only 4 percent oxygen desaturation.

STUDY OBJECTIVES: This analysis determined ∼5-year incident hypertension rates using the 2017 American College of Cardiology/American Heart Association blood pressure (BP) guidelines in individuals with obstructive sleep apnea (OSA) with hypopneas defined by a ≥ 3% oxygen desaturation or arousal but not by a hypopnea criterion of ≥ 4% oxygen desaturation (4% only). METHODS: Data were analyzed from participants in the Sleep Heart Health Study exam 2 (n = 1219) who were normotensive (BP ≤ 120/80 mm Hg) at exam 1. The AHI at exam 1 was classified into 4 categories of OSA severity: < 5, 5 ≤ 15, 15 ≤ 30, and ≥ 30 events/h using both the 3% oxygen desaturation or arousal and the 4% only definitions. Three definitions of hypertension-elevated BP (> 120/80 mm Hg), stage 1 (> 130/80 mm Hg), and stage 2 (> 140/90 mm Hg)-were used to determine incidence rates at exam 2. RESULTS: Five-year follow-up was available for 476 participants classified as having OSA by the 3% oxygen desaturation or arousal criterion but not by the 4% only standard at exam 1. Incident hypertension using American College of Cardiology/American Heart Association-defined BP categories in these discordantly classified individuals were 15% (elevated BP), 15% (stage 1), and 6% (stage 2). Hypertensive medications were used in 4% of participants who were normotensive. The overall incidence rate of at least an elevated BP was 40% (191/476) in those with OSA defined using the 3% oxygen desaturation or arousal criterion but not by the 4% only criterion. CONCLUSIONS: Use of the 4% only hypopnea definition resulted in the failure to identify a significant number of individuals with OSA who eventually developed hypertension and could have benefited from earlier diagnosis and treatment.

Associations between pain, objective sleep efficiency and cognition in patients with implantable cardioverter defibrillators.

INTRODUCTION: Patients with implantable cardioverter defibrillators (ICDs) frequently experience sleep disruption. Prior work shows associations between objective (actigraphic) sleep and cognition in these patients, but whether pain affects associations between measures of sleep fragmentation (eg, sleep efficiency, SE) and cognition is unknown. The present study examined independent and interactive associations between objective SE and pain on cognitive performance in patients with ICDs. METHODS: A total of 37 patients with ICDs (Mage = 60.0, SD = 12.4) and self-reported sleep disturbance completed 14 days of actigraphy. Average SE was computed [(average total sleep time/average time in bed) × 100%]. Patients completed the Short Form 36 Health Survey pain section, and computerized tasks measuring executive functioning (letter series, N-Back task), sustained attention/processing speed (symbol digit modalities test, SDMT), and simple reaction time. Multiple linear regressions examined whether SE independently predicted or interacted with pain ratings to predict cognitive performance. RESULTS: SE interacted with pain to predict SDMT performance, accounting for 12% unique variance. In patients reporting worse pain, higher SE was associated with better SDMT performance. Similar patterns of association on SDMT were not observed in patients with average or low pain. SE and pain ratings did not independently predict SDMT performance. Performance on other cognitive tasks was not associated with any predictors. CONCLUSION: Better sleep efficiency may play an important role in improving sustained attention/processing speed in patients with ICDs and perceived severe pain. Future research should examine whether interventions aimed at improving sleep fragmentation provide benefit to lower order cognition, particularly in patients with worse pain.

Artificial intelligence in sleep medicine: background and implications for clinicians.

None: Polysomnography remains the cornerstone of objective testing in sleep medicine and results in massive amounts of electrophysiological data, which is well-suited for analysis with artificial intelligence (AI)-based tools. Combined with other sources of health data, AI is expected to provide new insights to inform the clinical care of sleep disorders and advance our understanding of the integral role sleep plays in human health. Additionally, AI has the potential to streamline day-to-day operations and therefore optimize direct patient care by the sleep disorders team. However, clinicians, scientists, and other stakeholders must develop best practices to integrate this rapidly evolving technology into our daily work while maintaining the highest degree of quality and transparency in health care and research. Ultimately, when harnessed appropriately in conjunction with human expertise, AI will improve the practice of sleep medicine and further sleep science for the health and well-being of our patients.

Artificial intelligence in sleep medicine: an American Academy of Sleep Medicine position statement.

None: Sleep medicine is well positioned to benefit from advances that use big data to create artificially intelligent computer programs. One obvious initial application in the sleep disorders center is the assisted (or enhanced) scoring of sleep and associated events during polysomnography (PSG). This position statement outlines the potential opportunities and limitations of integrating artificial intelligence (AI) into the practice of sleep medicine. Additionally, although the most apparent and immediate application of AI in our field is the assisted scoring of PSG, we propose potential clinical use cases that transcend the sleep laboratory and are expected to deepen our understanding of sleep disorders, improve patient-centered sleep care, augment day-to-day clinical operations, and increase our knowledge of the role of sleep in health at a population level.

Effect of cloud-based sleep coaches on positive airway pressure adherence.

STUDY OBJECTIVES: Decreased early positive airway pressure (PAP) adherence is predictive of poor long-term adherence. We hypothesized that cloud-based sleep coaches (CBSC) providing protocol-driven live telephone contact with patients starting treatment would improve early adherence. METHODS: At PAP set-up patients were randomized to: (1) standard care (SC) including respiratory therapist PAP setup, wireless adherence monitoring, and elective use of a mobile adherence feedback application (PAPapp); or (2) SC+CBSC. Primary 3-month endpoints were adherence (all nights, nights used, % of nights ≥ 4 hours use, and % participants with ≥ 4 hours use on ≥ 70% of nights [% ≥ 4 ≥ 70%]) and secondary endpoints were change in Epworth sleepiness scale (ESS) and satisfaction with treatment and PAPapp use. RESULTS: Two hundred fifty participants were randomized (SC 126, SC+CBSC 124). Characteristics SC versus SC+CBSC (mean ± SD) for age (55.2 ± 13.4 versus 54.9 ± 11.5 years), diagnostic apnea-hypopnea index (36.7 ± 21.1 versus 36.6 ± 20.6 events/h), and ESS (10.8 ± 6.1 versus 11.2 ± 6.0) did not differ. At 3 months, the % of days with ≥ 4 hours of PAP use (SC: 48.1 ± 36.8% versus SC+CBSC: 57.9 ± 35.4%, P = 0.032), use all nights (SC:3.7 ± 2.7 hours versus SC + CBSC: 4.4 ± 2.6 hours, P=0.027), and PAPapp use satisfaction were greater with SC+CBSC (intention to treat analysis). The [% ≥ 4 ≥ 70%] did not differ between groups in the intention to treat analysis but was higher in those completing CBSC interventions. The ESS improvement and patient satisfaction did not differ between groups. CONCLUSIONS: The CBSC system improved PAP adherence at 3 months. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: ThErapy Adherence Management in Veterans; Identifier: NCT03243487; URL: https://clinicaltrials.gov/ct2/show/NCT03243487.

Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults.

OBJECTIVE: Behavioral treatments for insomnia improve sleep in older adults, but research documenting their effects on cognitive performance is mixed. We explored whether a brief behavioral treatment for insomnia (BBTi) impacts daily associations between sleep parameters and next day cognition. METHODS: Sixty-two older adults (Mage = 69.45 years, SD = 7.71) with insomnia completed either 4 weeks of BBTi or self-monitoring control (SMC). At baseline, post-treatment, and 3 month follow-up, participants completed 14 days of diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series). At each time period, associations between sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2nd Edition scores), were examined through multilevel modeling. RESULTS: At post-treatment, we observed an interactive fixed effect of treatment condition (i.e., BBTi/SMC) and TST on daily SDMT and letter series performance. For BBTi, longer TST was associated with better letter series performance, and did not predict SDMT performance. For SMC, longer TST was associated with worse SDMT, and was not associated with letter series performance. Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment. Associations were not maintained at follow-up. CONCLUSIONS: Sleep duration may play an important role in BBTi-related improvements in daily higher order cognition. Maintenance of these associations may be facilitated by booster sessions following post-treatment. CLINICAL TRIAL IDENTIFIER: NCT02967185.

Blood pressure monitoring in sleep: time to wake up.

Hypertension is a highly common condition with well-established adverse consequences. Ambulatory blood pressure monitoring has repeatedly been shown to better predict cardiovascular outcomes and mortality, compared to single office visit blood pressure. Non-dipping of sleep-time blood pressure is an independent marker for increased cardiovascular risk. We review blood pressure variability and the challenges of blood pressure monitoring during sleep. Although pathological sleep such as obstructive sleep apnea has been associated with non-dipping of sleep-time blood pressure, blood pressure is not routinely measured during sleep due to lack of unobtrusive blood pressure monitoring technology. Second, we review existing noninvasive continuous blood pressure monitoring technologies. Lastly, we propose including sleep-time blood pressure monitoring during sleep studies and including sleep studies in patients undergoing ambulatory blood pressure monitoring.

The Association Between Obstructive Sleep Apnea Characterized by a Minimum 3 Percent Oxygen Desaturation or Arousal Hypopnea Definition and Hypertension.

STUDY OBJECTIVES: The association between obstructive sleep apnea (OSA) and hypertension in prior studies has been determined using a definition of hypopnea requiring a 4% O2 desaturation. However, the American Academy of Sleep Medicine (AASM) recommends using a 3% O2 desaturation or an arousal. This analysis assesses the relationship between OSA and hypertension utilizing the AASM recommended definition and the 2018 American College of Cardiology/American Heart Association hypertension guidelines. METHODS: Data from 6113 participants from the Sleep Heart Health Study were analyzed. The AASM recommended apnea-hypopnea index (AHI) was classified into 4 categories of OSA severity: < 5, 5 to < 15, 15 to < 30 and ≥ 30 events/h. Three definitions of hypertension were used: elevated (> 120/< 80 or use of hypertension medications [meds]), stage 1/stage 2 (> 130/80 or meds), stage 2 (> 140/90 or meds). Data were analyzed using logistic regression controlling for demographics, smoking and body mass index. Multiple linear regression analysis assessed the relationship between natural log AHI, and systolic and diastolic blood pressure controlling for the same covariates. RESULTS: For all definitions of blood pressure elevation, increasing OSA severity was associated with greater likelihood of an elevated or hypertensive status in fully adjusted models (odds ratio [95% confidence interval]): elevated 1.30 (1.09-1.54), 1.39 (1.13-1.70) 1.69 (1.29-2.13); stage 1/2: 1.25 (1.06-1.47), 1.32 (1.10-1.59), 1.53 (1.23-1.91); stage 2: 1.07 (0.91-1.25), 1.21 (1.01-1.44), 1.37 (1.11-1.69) for AHI 5 to < 15, 15 to < 30 and > 30 events/h (< 5 events/h reference). Linear regression found that AHI was associated with both systolic and diastolic blood pressure in fully adjusted models. CONCLUSIONS: Use of the AASM recommended definition of hypopnea as a component of the AHI is associated with the presence of hypertension. CITATION: Budhiraja R, Javaheri S, Parthasarathy S, Berry RB, Quan SF. The association between obstructive sleep apnea characterized by a minimum 3 percent oxygen desaturation or arousal hypopnea definition and hypertension. J Clin Sleep Med. 2019;15(9):1261-1270.

NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.

STUDY OBJECTIVES: Compare treatment efficacy and objective adherence between the NightBalance sleep position treatment (SPT) device and auto-adjusting positive airway pressure (APAP) in patients with exclusive positional obstructive sleep apnea (ePOSA) defined as a supine apnea-hypopnea index (sAHI) ≥ 2 times the nonsupine AHI (nsAHI) and a nsAHI < 10 events/h. METHODS: This prospective multicenter randomized crossover trial enrolled treatment naive participants with ePOSA (AHI ≥ 15 events/h and nsAHI < 10 events/h) or (AHI > 10 and < 15 events/h with daytime sleepiness and nsAH < 5 events/h). Polysomnography and objective adherence determination (device data) were performed at the end of each 6-week treatment. Patient device preference was determined at the end of the study. RESULTS: A total of 117 participants were randomized (58 SPT first, 59 APAP first). Of these, 112 started treatment with the second device (adherence cohort) and 110 completed the study (AHI cohort). The AHI on SPT was higher (mean ± standard deviation, 7.29 ± 6.8 versus 3.71 ± 5.1 events/h, P < .001). The mean AHI difference (SPT-APAP) was 3.58 events/h with a one sided 95% confidence interval upper bound of 4.96 events/h (< the prestudy noninferiority margin of 5 events/h). The average nightly adherence (all nights) was greater on SPT (345.3 ± 111.22 versus 286.98 ± 128.9 minutes, P < .0001). Participants found the SPT to be more comfortable and easier to use and 53% reported a preference for SPT assuming both devices were equally effective. CONCLUSIONS: Treatment with SPT resulted in non-inferior treatment efficacy and greater adherence compared to APAP in ePOSA suggesting that SPT is an effective treatment for this group. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea; Identifier: NCT03061071; URL: https://clinicaltrials.gov/ct2/show/NCT03061071.