Resmed Announces Small, Easy to Use Home Sleep Apnea Test, NightOwl™, Now Available Across the US

FDA-cleared home sleep test provides an effective and simplified solution to obstructive sleep apnea testing and diagnosis April 03, 2025 09:00 ET | Source: Resmed, Inc. SAN DIEGO, April 03, 2025 (GLOBE NEWSWIRE) -- Resmed (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in the home, today announced its home sleep apnea test, NightOwl™, is now available across the United States. NightOwl is an FDA-cleared home sleep apnea test (HSAT) designed to offer healthcare providers a simplified, accurate, and efficient way to diagnose obstructive sleep apnea (OSA) from the comfort of an individual’s home. OSA, a sleep disorder where breathing repeatedly stops during sleep due to blocked upper airways, affects nearly one billion people globally1, yet approximately 80% of cases remain undiagnosed and untreated2. Additionally, a recent study published in The Lancet Respiratory Medicine found that treating OSA with CPAP therapy can significantly reduce the risk of death3 - underscoring the importance of accessible and simplified diagnostic options. NightOwl makes it easy to detect OSA with a small sensor worn on the fingertip and simple, easy-to-use digital platforms for both individuals and providers. By making OSA testing more convenient and accessible, NightOwl supports Resmed’s vision to help people achieve their full potential through better sleep and breathing, with care delivered in their own home. “Now more than ever, people want healthcare experiences that are easy, convenient, and accessible, however, navigating sleep apnea testing can be complex,” said Carlos M. Nunez, M.D., Chief Medical Officer at Resmed. “With NightOwl, people can easily complete a sleep apnea test from the comfort of home using just a fingertip sensor and a smartphone. It also simplifies the process for providers. This is a meaningful step forward in Resmed’s mission to deliver life-changing health technology that people love.” NightOwl is a disposable HSAT device that records up to 10 nights of sleep data for a single patient, capturing night-to-night variability and providing clinicians with a comprehensive view of an individual’s sleep patterns. Sleep data is sent remotely to a cloud-based diagnostic platform for physician analysis and review, enabling quick interpretation, streamlining diagnostic workflows, and helping individuals receive more timely diagnoses, if applicable. Additional key features of NightOwl, include: Auto-Scored Results: Raw patient data is autoscored with an algorithm that is clinically validated against polysomnography (PSG), saving time for sleep specialists and clinicians.Seamless Integration with Resmed’s Somnoware: Enhances diagnostic workflows by integrating with leading sleep lab management software, purchased separately.Fully Disposable: Eliminates the need for device returns, cleaning, or reprocessing, reducing operational burdens for healthcare providers.Pairing with Resmed’s myAir™ app: The device pairs with the myAir™ app, providing individuals with step-by-step guidance throughout the testing process. NightOwl uses peripheral arterial tonometry technology, a noninvasive method that measures blood flow changes, oxygen saturation, and pulse rate changes, to detect OSA. According to a multicenter validation study, NightOwl results using peripheral arterial tonometry technology showed close agreement with expert scored sleep lab testing PSG in its estimate of sleep apnea severity and clinical performance. This publication serves as additional clinical validation of the diagnostic accuracy of NightOwl, for both 3% and 4% hypopnea desaturation scoring rules, in addition to the studies indicating a high degree of accuracy that were reviewed by the FDA4. NightOwl is now widely available across the United States. Individuals interested in NightOwl should speak with their healthcare provider for more information. To learn more, visit: https://www.resmed.com/en-us/health-professionals/products/home-sleep-testing/nightowl/ About Resmed Resmed (NYSE: RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed. ________________________1 Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. PMID: 31300334; PMCID: PMC7007763.2 Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 ;20(9):705-63 Benjafield et al; Positive airway pressure therapy and all-cause and cardiovascular mortality in people with obstructive sleep apnoea: a systematic review and meta-analysis of randomised controlled trials and confounder-adjusted, non-randomised controlled studies; Lancet Respir Med 20254 Van Pee, B et al; A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry; Sleep 2022

Resmed Announces Small, Easy to Use Home Sleep Apnea Test, NightOwl™, Now Available Across the US

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