Sex-specific associations between daytime sleepiness, chronic diseases and mortality in obstructive sleep apnea.

Objective: Excessive daytime sleepiness (EDS) is common in obstructive sleep apnea (OSA) and has been linked to adverse outcomes, albeit inconsistently. Furthermore, whether the prognostic impact of EDS differs as a function of sex is unclear. We aimed to assess the associations between EDS and chronic diseases and mortality in men and women with OSA. Methods: Newly-diagnosed adult OSA patients who underwent sleep evaluation at Mayo Clinic between November 2009 and April 2017 and completed the Epworth Sleepiness Scale (ESS) for assessment of perceived sleepiness (N = 14,823) were included. Multivariable-adjusted regression models were used to investigate the relationships between sleepiness, with ESS modeled as a binary (ESS > 10) and as a continuous variable, and chronic diseases and all-cause mortality. Results: In cross-sectional analysis, ESS > 10 was independently associated with lower risk of hypertension in male OSA patients (odds ratio [OR], 95% confidence interval [CI]: 0.76, 0.69-0.83) and with higher risk of diabetes mellitus in both OSA men (OR, 1.17, 95% CI 1.05-1.31) and women (OR 1.26, 95% CI 1.10-1.45). Sex-specific curvilinear relations between ESS score and depression and cancer were noted. After a median 6.2 (4.5-8.1) years of follow-up, the hazard ratio for all-cause death in OSA women with ESS > 10 compared to those with ESS ≤ 10 was 1.24 (95% CI 1.05-1.47), after adjusting for demographics, sleep characteristics and comorbidities at baseline. In men, sleepiness was not associated with mortality. Conclusion: The implications of EDS for morbidity and mortality risk in OSA are sex-dependent, with hypersomnolence being independently associated with greater vulnerability to premature death only in female patients. Efforts to mitigate mortality risk and restore daytime vigilance in women with OSA should be prioritized.

Age and weight considerations for the use of continuous positive airway pressure therapy in pediatric populations: an American Academy of Sleep Medicine position statement.

This position statement provides guidance for age and weight considerations for using continuous positive airway pressure therapy in pediatric populations. The American Academy of Sleep Medicine commissioned a task force of experts in pediatric sleep medicine to review the medical literature and develop a position statement based on a thorough review of these studies and their clinical expertise. The American Academy of Sleep Medicine Board of Directors approved the final position statement. It is the position of the American Academy of Sleep Medicine that continuous positive airway pressure can be safe and effective for the treatment of obstructive sleep apnea for pediatric patients, even in children of younger ages and lower weights, when managed by a clinician with expertise in evaluating and treating pediatric obstructive sleep apnea. The clinician must make the ultimate judgment regarding any specific care in light of the individual circumstances presented by the patient, accessible treatment options, patient/parental preference, and resources. CITATION: Amos L, Afolabi-Brown O, Gault D, et al. Age and weight considerations for the use of continuous positive airway pressure therapy in pediatric populations: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2022;18(8):2041-2043.

Enhancing public health and safety by diagnosing and treating obstructive sleep apnea in the transportation industry: an American Academy of Sleep Medicine position statement.

Obstructive sleep apnea (OSA) may lead to serious health, safety, and financial implications-including sleepiness-related crashes and incidents-in workers who perform safety-sensitive functions in the transportation industry. Evidence and expert consensus support its identification and treatment in high-risk commercial operators. An Advanced Notice of Proposed Rulemaking regarding the diagnosis and treatment of OSA in commercial truck and rail operators was issued by the Federal Motor Carrier Safety Administration and Federal Railroad Administration, but it was later withdrawn. This reversal has led to questions about whether efforts to identify and treat OSA are warranted. In the absence of clear directives, we urge key stakeholders, including clinicians and patients, to engage in a collaborative approach to address OSA by following, at a minimum, the 2016 guidelines issued by a Medical Review Board of the Federal Motor Carrier Safety Administration, alone or in combination with 2006 guidance by a joint task force. The current standard of care demands action to mitigate the serious health and safety risks of OSA. CITATION: Das AM, Chang JL, Berneking M, et al. Enhancing public health and safety by diagnosing and treating obstructive sleep apnea in the transportation industry: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2022;18(10):2467-2470.

Orthogonal pre-use and post-use efficiency testing for single-use anion exchange chromatography.

Three efficiency tests for single-use AEX chromatography devices have been developed and applied to six capsule formats of a new, salt tolerant, single-use AEX product. All the tests have been designed to be performed with simple equipment and common reagents. By performing each of the three tests on undamaged capsules and capsules intentionally damaged with small defects, in tandem with Phi-X174 challenges in a high-salt buffer, relationships between test results and viral clearance have been obtained. A pre-use pressure-based installation verification test is simply performed during equilibration of the device and effective at identifying gross bypass defects, for example, due to internal seal breakage. Passing outcomes of a post-use installation validation bubble point test are associated with ≥ 5 log reduction value (LRV) of viral clearance. A new, non-destructive, pre-use AEX capacity test involves challenging the device with chloride ions and is orthogonal to the other two tests in that it can detect chemical defects, as well as mechanical ones. Passing outcomes of this test correspond to > 2 LRV viral clearance and provide in situ assurance of the expected AEX dynamic capacity prior to use. Selection of a pair of pre-use and post-use tests can provide robust risk reduction with respect to viral clearance by single-use AEX devices in biopharmaceutical purifications.

Optimal NIV Medicare Access Promotion: Patients With OSA: 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 the work of the CPAP and bilevel PAP therapy for OSA Technical Expert Panel working group. For positive airway pressure (PAP) therapy, the most pressing current coverage barriers identified were: an insufficient symptom list describing all potential symptoms in patients with mild OSA; the 4 h per night of PAP usage requirement to keep the device; the additional sleep studies requirement to re-qualify for PAP or supplemental oxygen; and the inability to use telehealth visits for follow-up visits. Critical evidence supports changes to current policies and includes: symptom list inadequate to cover all scenarios based on updated clinical practice guidelines; published evidence that 2 h per night of PAP use can result in benefit to quality of life and other metrics; the costs of another sleep study not justified for all nonadherent patients or for supplemental oxygen due to other types of assessment currently available; and the remarkable success and acceptance of telehealth visits. To achieve optimal access for patients on PAP therapy, we make the following key suggestions: removing symptom criteria for mild OSA; reduce continued coverage criteria to > 2 h per night; eliminate the need for a sleep study to re-qualify if nonadherent or for new Centers for Medicare & Medicaid Services beneficiaries already on and adherent to PAP therapy; allow telehealth visits for documenting benefit and adherence; and allow PAP reports and domiciliary oximetry to qualify for supplemental oxygen with PAP if needed. This paper shares our best vision for bringing the right device to the right patient at the right time.

Does testing for sleep-disordered breathing predischarge vs postdischarge result in different treatment outcomes?

STUDY OBJECTIVES: Treatment of sleep-disordered breathing may improve health-related outcomes postdischarge. However timely definitive sleep testing and provision of ongoing therapy has been a challenge. Little is known about how the time of testing-during hospitalization vs after discharge-affects important outcomes such as treatment adherence. METHODS: We conducted a 10-year retrospective study of hospitalized adults who received an inpatient sleep medicine consultation for sleep-disordered breathing and subsequent sleep testing. We divided them into inpatient and outpatient sleep testing cohorts and studied their clinical characteristics, follow-up, positive airway pressure adherence, pressure adherence, hospital readmission and mortality. RESULTS: Of 485 patients, 226 (47%) underwent inpatient sleep testing and 259 (53%) had outpatient sleep testing. The median age was 68 years old (interquartile range = 57-78), and 29.6% were females. The inpatient cohort had a higher Charlson Comorbidity Index (4 [3-6] vs 3[2-5], P ≤ .0004). A higher Charlson Comorbidity Index (hazard ratio = 1.14, 95% confidence interval:1.03-1.25, P = .001), body mass index (hazard ratio = 1.03, 95% confidence interval:1.0-1.05, P = .008), and stroke (hazard ratio = 2.22, 95% confidence interval:1.0-4.9, P = .049) were associated with inpatient sleep testing. The inpatient cohort kept fewer follow-up appointments (39.90% vs 50.62%, P = .03); however positive airway pressure adherence was high among those keeping follow-up appointments (88.9% [inpatient] vs 85.71% [outpatient], P = .55). The inpatient group had an increased risk for death (hazard ratio: 1.82 95% confidence interval 1.28-2.59, P ≤ .001) but readmission rates did not differ. CONCLUSIONS: Medically complex patients were more likely to receive inpatient sleep testing but less likely to keep follow-up, which could impact adherence and effectiveness of therapy. Novel therapeutic interventions are needed to increase sleep medicine follow-up postdischarge, which may result in improvement in health outcomes in hospitalized patients with sleep-disordered breathing. CITATION: Orbea CP, Jenad H, Kassab LL, et al. Does testing for sleep-disordered breathing predischarge vs postdischarge result in different treatment outcomes? J Clin Sleep Med. 2021;17(12):2451-2460.

Sleep is essential to health: an American Academy of Sleep Medicine position statement.

CITATION: Sleep is a biological necessity, and insufficient sleep and untreated sleep disorders are detrimental for health, well-being, and public safety. Healthy People 2030 includes several sleep-related objectives with the goal to improve health, productivity, well-being, quality of life, and safety by helping people get enough sleep. In addition to adequate sleep duration, healthy sleep requires good quality, appropriate timing, regularity, and the absence of sleep disorders. It is the position of the American Academy of Sleep Medicine (AASM) that sleep is essential to health. There is a significant need for greater emphasis on sleep health in education, clinical practice, inpatient and long-term care, public health promotion, and the workplace. More sleep and circadian research is needed to further elucidate the importance of sleep for public health and the contributions of insufficient sleep to health disparities. CITATION: Ramar K, Malhotra RK, Carden KA, et al. Sleep is essential to health: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2021;17(10):2115-2119.

Contralateral Rerouting of Hypoglossal Nerve Implant Pulse Generator and Stimulation Lead.

As use of hypoglossal nerve stimulators has become more widespread in the treatment of obstructive sleep apnea, certain scenarios have dictated alterations to the previously described surgical technique. This report describes a situation in which revision of a hypoglossal nerve stimulator implant was required given the need for breast cancer surgery. It serves as the first description of the contralateral rerouting of a stimulation lead to a left-sided impulse generator and the first description of respiratory sensing lead placement within the left second intercostal space for such a device. Laryngoscope, 131:E2409-E2412, 2021.

Daylight saving time: an American Academy of Sleep Medicine position statement.

None: The last several years have seen intense debate about the issue of transitioning between standard and daylight saving time. In the United States, the annual advance to daylight saving time in spring, and fall back to standard time in autumn, is required by law (although some exceptions are allowed under the statute). An abundance of accumulated evidence indicates that the acute transition from standard time to daylight saving time incurs significant public health and safety risks, including increased risk of adverse cardiovascular events, mood disorders, and motor vehicle crashes. Although chronic effects of remaining in daylight saving time year-round have not been well studied, daylight saving time is less aligned with human circadian biology-which, due to the impacts of the delayed natural light/dark cycle on human activity, could result in circadian misalignment, which has been associated in some studies with increased cardiovascular disease risk, metabolic syndrome and other health risks. It is, therefore, the position of the American Academy of Sleep Medicine that these seasonal time changes should be abolished in favor of a fixed, national, year-round standard time.

Sleep, fatigue and burnout among physicians: an American Academy of Sleep Medicine position statement.

None: Physician burnout is a serious and growing threat to the medical profession and may undermine efforts to maintain a sufficient physician workforce to care for the growing and aging patient population in the United States. Burnout involves a host of complex underlying associations and potential for risk. While prevalence is unknown, recent estimates of physician burnout are quite high, approaching 50% or more, with midcareer physicians at highest risk. Sleep deprivation due to shift-work schedules, high workload, long hours, sleep interruptions, and insufficient recovery sleep have been implicated in the genesis and perpetuation of burnout. Maladaptive attitudes regarding sleep and endurance also may increase the risk for sleep deprivation among attending physicians. While duty-hour restrictions have been instituted to protect sleep opportunity among trainees, virtually no such effort has been made for attending physicians who have completed their training or practicing physicians in nonacademic settings. It is the position of the American Academy of Sleep Medicine that a critical need exists to evaluate the roles of sleep disruption, sleep deprivation, and circadian misalignment in physician well-being and burnout. Such evaluation may pave the way for the development of effective countermeasures that promote healthy sleep, with the goal of reducing burnout and its negative impacts such as a shrinking physician workforce, poor physician health and functional outcomes, lower quality of care, and compromised patient safety.

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.

Chronic Opioid Therapy and Sleep: An American Academy of Sleep Medicine Position Statement.

None: There is a complex relationship among opioids, sleep and daytime function. Patients and medical providers should be aware that chronic opioid therapy can alter sleep architecture and sleep quality as well as contribute to daytime sleepiness. It is also important for medical providers to be cognizant of other adverse effects of chronic opioid use including the impact on respiratory function during sleep. Opioids are associated with several types of sleep-disordered breathing, including sleep-related hypoventilation, central sleep apnea (CSA), and obstructive sleep apnea (OSA). Appropriate screening, diagnostic testing, and treatment of opioid-associated sleep-disordered breathing can improve patients' health and quality of life. Collaboration among medical providers is encouraged to provide high quality, patient-centered care for people who are treated with chronic opioid therapy.

Noninvasive volume-assured pressure support for chronic respiratory failure: a review.

PURPOSE OF REVIEW: Noninvasive ventilation (NIV) is an established treatment for chronic hypercapnic respiratory failure (CRF). Volume-assured pressure support (VAPS) is a mode of NIV that automatically adjusts inspiratory pressure in order to maintain a constant respiratory volume. We aim to discuss the role and application of VAPS in CRF. RECENT FINDINGS: Recently published meta-analyses and reviews fail to demonstrate a significant difference in gas exchange, sleep, or quality-of-life improvement between VAPS and bilevel positive airway pressure (BPAP) in patients with CRF. A recent manuscript suggests that VAPS therapy in chronic obstructive pulmonary disease patients may reduce the number of exacerbations. It has been shown that with a protocol-driven approach BPAP and VAPS can both be successfully titrated during a single split-night polysomnography. SUMMARY: VAPS is as effective as other modes of NIV at improving ventilation and sleep in CRF. The potential advantage is a more consistent ventilatory support through daytime-nighttime variations and progression of disease over time. However, the impact on long-term outcomes, such as survival, has not been studied.

A Randomized, Placebo-Controlled Trial to Assess the Effects of 8 Weeks of Administration of GSK256073, a Selective GPR109A Agonist, on High-Density Lipoprotein Cholesterol in Subjects With Dyslipidemia.

GPR109A (HM74A), a G-protein-coupled receptor, is hypothesized to mediate lipid and lipoprotein changes and dermal flushing associated with niacin administration. GSK256073 (8-chloro-3-pentyl-1H-purine-2,6[3H,7H]-dione) is a selective GPR109A agonist shown to suppress fatty acid levels and produce mild flushing in short-term clinical studies. This study evaluated the effects of GSK256073 on lipids in subjects with low high-density lipoprotein cholesterol (HDLc). Subjects (n = 80) were randomized (1:1:1:1) to receive GSK256073 5, 50, or 150 mg/day or matching placebo for 8 weeks. The primary end point was determining the GSK256073 exposure-response relationship for change from baseline in HDLc. No significant exposure response was observed between GSK256073 and HDLc levels. GSK256073 did not significantly alter HDLc levels versus placebo, but rather revealed a trend at the 150-mg dose for a nonsignificant decrease in HDLc (-6.31%; P = .12) and an increase in triglycerides (median, 24.4%; 95% confidence interval, 7.3%-41.6%). Flushing was reported in 21%, 25%, and 60% of subjects (5, 50, and 150 mg, respectively) versus 24% for placebo. Results indicated that selective activation of the GPR109A receptor with GSK256073 did not produce niacin-like lipid effects. These findings add to the increasing evidence that niacin-mediated lipoprotein changes occur predominantly via GPR109A-independent pathways.

Correlation of the Epworth Sleepiness Scale and Sleep-Disordered Breathing in Men and Women.

STUDY OBJECTIVES: To compare Epworth Sleepiness Scale (ESS) scores of men and women and determine if there is a correlation with sleep-disordered breathing (SDB) based on subsequent polysomnography (PSG). METHODS: Consecutive adult patients were identified who completed ESS and PSG at Mayo Clinic in Rochester, Minnesota, between January 1, 2013, and January 31, 2015. Apnea-hypopnea index (AHI) ≥ 5 events/h was classified as presence of SDB, and increasing values represented greater severity. RESULTS: Among 6,593 patients with valid ESS scores and timely subsequent PSG, 42% were women. Mean (standard deviation [SD]) age of women was 56.2 (15.2) years; men, 58.5 (15.1) years. Mean (SD) ESS score was 9.5 (5.4) for women and 9.5 (5.3) for men. SDB was present in 83.6% of men and 68.3% of women. Mean (SD) AHI of men was 25.9 (26.7) events/h; women, 16.1 (22.4) events/h (P < .001). Each unit increase in ESS score of men was associated with a 0.51-unit increase in AHI (P < .001); women had a 0.16-unit associated increase (P = .04) (effect ratio, threefold greater for men). PSG demonstrated that women had greater sleep efficiency, less respiratory effort-related arousals, and less hypoxemia (all P < .001). Among women, ESS did not correlate with presence of SDB or mild to moderate SDB. There was a small association in women with severe SDB. CONCLUSIONS: ESS is not correlated with SDB at mild to moderate levels in women and has a smaller association than in men with severe SDB. Further work is necessary to understand sex-specific differences in patients with SDB.

Practical Implementation of a Single-Night Split-Titration Protocol With BPAP-ST and AVAPS in Patients With Neuromuscular Disease.

STUDY OBJECTIVES: At the sleep laboratory, noninvasive positive pressure ventilation titration protocols in patients with neuromuscular disease (NMD) are based on standard pressure cycle devices in a spontaneous/timed mode (BPAP-ST). Experience integrating protocols on average volume-assured pressure support (AVAPS) mode is limited, prompting us to develop a practical single-night titration protocol that provides information to assist clinicians and patients as they decide between BPAP-ST and AVAPS modes. METHODS: We implemented a sequential titration protocol of BPAP-ST followed by AVAPS during a single-night polysomnography study in patients with NMD and reported polysomnographic and clinical metrics. RESULTS: There were 27 patients who completed the protocol: 14 (52%) were male with median and interquartile range (IQR) 64 (59 to 70) years of age and body mass index of 29.6 (25.6-32) kg/m2. They had median (IQR) maximal percent predicted inspiratory and expiratory pressures, and percent vital capacity of 33 (24 to 54), 34 (22 to 47) and 60 (47 to 74), respectively. At final titration of each device, average tidal volume and nadir non-rapid eye movement sleep oxyhemoglobin saturation (SpO2) were higher and respiratory rate/tidal volume, transcutaneous CO2, and arousal index were lower on AVAPS (P < .05) in comparison with BPAP-ST. Full face mask was used in 23 patients (85%). None of the other ventilatory or sleep parameters differed significantly between BPAP-ST and AVAPS (P > .05) sessions. CONCLUSIONS: A practical single-night split-titration protocol with BPAP-ST and AVAPS can successfully be implemented in patients with NMD, assisting clinicians and patients with the decision on initial treatment modalities and settings.

Clinical Use of a Home Sleep Apnea Test: An Updated American Academy of Sleep Medicine Position Statement.

ABSTRACT: The diagnosis and effective treatment of obstructive sleep apnea (OSA) in adults is an urgent health priority. It is the position of the American Academy of Sleep Medicine (AASM) that only a medical provider can diagnose medical conditions such as OSA and primary snoring. Throughout this statement, the term "medical provider" refers to a licensed physician and any other health care professional who is licensed to practice medicine in accordance with state licensing laws and regulations. A home sleep apnea test (HSAT) is an alternative to polysomnography for the diagnosis of OSA in uncomplicated adults presenting with signs and symptoms that indicate an increased risk of moderate to severe OSA. It is also the position of the AASM that: the need for, and appropriateness of, an HSAT must be based on the patient's medical history and a face-to-face examination by a medical provider, either in person or via telemedicine; an HSAT is a medical assessment that must be ordered by a medical provider to diagnose OSA or evaluate treatment efficacy; an HSAT should not be used for general screening of asymptomatic populations; diagnosis, assessment of treatment efficacy, and treatment decisions must not be based solely on automatically scored HSAT data, which could lead to sub-optimal care that jeopardizes patient health and safety; and the raw data from the HSAT device must be reviewed and interpreted by a physician who is either board-certified in sleep medicine or overseen by a board-certified sleep medicine physician.