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This month in review focuses on early-stage clinical trials of sleep medicine and insights from sleep experts on topics such as OSA and CSA.
With July being a slower month for pipeline news in sleep medicine, this month in review recaps new studies and revisits several topics presented at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies in Houston. Sleep experts discussed various topics, including central sleep apnea (CSA), idiopathic hypersomnia, optimizing sleep for elite athletes' peak performance, and the heterogeneity of pediatric obstructive sleep apnea (OSA).
A recent study found that < 7 or > 9 hours of sleep in type 2 diabetes patients is linked to a higher prevalence of microvascular disease. This study, led by Mette Johansen and Thomas Olesen from Steno Diabetes Center Odense, involved 396 participants and used accelerometers to measure sleep. Results indicated that short and long sleep durations significantly increased the odds of microvascular disease. The association was stronger in participants > 62 years old, suggesting older individuals are more vulnerable to sleep-related complications in diabetes.
Young adults aged 20–40 with OSA have greater rates of cardiovascular disease (CVD) than older adults with OSA, a new study found. This challenges the belief that CVD risk is greater in older adults. The study highlights the need for OSA screening in primary care, especially for younger adults. Using data from the National Health and Nutrition Examination Survey, researchers found that young adults with OSA were significantly more likely to have hypertension, metabolic syndrome, and CVD events compared to their peers without OSA, emphasizing the serious health implications of untreated OSA.
Phase 2 data revealed KP1077 (serdexmethylphenidate or SDX) significantly improves excessive daytime sleepiness, sleep inertia, brain fog, and patient-reported outcomes in idiopathic hypersomnia patients. Announced on June 3, 2024, at SLEEP 2024, the placebo-controlled, double-blind trial showed KP1077 was well-tolerated with mild adverse events. The trial involved 50 patients, split into once-a-day and twice-a-day dosing, showing greater efficacy in the former. Zevra Therapeutics is planning a phase 3 trial after positive phase 2 results, aiming to provide a new stimulant-based treatment for idiopathic hypersomnia, a significant step forward for patients and physicians.
At SLEEP 2024, M. Safwan Badr, MD, discussed emerging treatments for CSA including adaptive servo-ventilation, hypoglossal nerve stimulation, and pharmacological interventions. Adaptive servo-ventilation, once halted due to mortality concerns, is now considered safe following a 2023 study. Hypoglossal nerve stimulation shows promise in improving respiratory events and quality of life. Pharmacological interventions, particularly acetazolamide, may benefit patients with high CSA propensity. Badr emphasized the importance of starting with traditional therapies like CPAP and carefully considering new treatments, always prioritizing patient partnership in decision-making.
Jesse D. Cook, MS, from the University of Wisconsin-Madison, emphasized the role of sleep in optimizing athletic performance. Good sleep enhances cognitive function, speed, and emotional regulation. Cook discussed personalized sleep strategies, considering circadian rhythms, and travel impacts. Research shows better sleep improves athletic performance, though its impact on actual game outcomes requires further study. Personalized sleep strategies are essential for athletes' peak performance and overall health.
Heterogeneity affects OSA diagnosis, noted David Gozal, MD, at SLEEP 2024. OSA varies in patients due to environmental, lifestyle, and genetic factors, impacting diagnosis and severity. Gozal highlighted pediatric OSA heterogeneity, influenced by pathophysiology and consequences. For example, children with similar OSA severity may experience different morbidities. Understanding these variations helps tailor treatment. Current diagnosis relies on symptoms and sleep studies, but Gozal stressed the need for more sophisticated technologies to capture the full biological impact, noting that some children with normal sleep studies still suffer from OSA symptoms.