Sleep Cycle Begins Clinical Trial for Smartphone Sleep Apnea Detection

Sleep technology company Sleep Cycle has commenced a clinical study to validate its innovative smartphone-based feature for screening and monitoring obstructive sleep apnea, marking a significant advancement in accessible digital health solutions that require no additional hardware or wearables.

The initiative addresses a critical global health challenge, with obstructive sleep apnea affecting an estimated 950 million adults aged 30-69 worldwide, of which approximately 80% remain undiagnosed. This widespread condition, often termed a "silent epidemic," is associated with serious health complications including cardiovascular disease, cognitive decline, and diminished quality of life. The home sleep apnea testing market, projected to grow from $712 million in 2025 to $966 million by 2035, underscores the urgent need for scalable diagnostic solutions.

"Sleep is the next frontier in preventive health, and we're here to lead it," said Erik Jivmark, Chief Executive Officer at Sleep Cycle. "By enabling sleep apnea screening using nothing but an iPhone, we're not just breaking clinical barriers—we're unlocking a scalable opportunity to transform lives and redefine the digital health market. This isn't just an app update; it's a strategic leap into a multi-billion dollar category ripe for innovation."

The clinical study, which began on June 2nd, is being conducted at Sleep Testing Australia clinics in Brisbane and Adelaide with approximately 700 participants. Leading the research are Dr. Mike Gradisar, Head of Sleep Science at Sleep Cycle serving as Principal Investigator, and Dr. Mikael Kågebäck, the company's Chief Technology Officer with a PhD in AI and Machine Learning.

Sleep Cycle's approach leverages proprietary AI-powered audio analysis technology to detect potential sleep apnea indicators through smartphone microphones alone. "Our AI-powered audio analysis is built on a proprietary sound model trained to identify subtle sleep-related breathing patterns in real-world environments," explained Dr. Kågebäck. "Unlike traditional methods, our solution analyzes sound in a context-aware manner, enabling detection of potential sleep apnea signs without intrusive wearables or sensors. This marks a new frontier in accessible sleep diagnostics."

The technology aims to democratize sleep health by providing an intuitive, competitively priced solution particularly beneficial for underserved populations lacking access to specialized sleep clinics or expensive diagnostic equipment. By utilizing widely available smartphone technology, Sleep Cycle seeks to bridge the significant diagnostic gap in sleep apnea detection.

The study has received formal ethical approval and adheres to international clinical research standards. Sleep Cycle has also completed a pre-submission dialogue with the U.S. Food and Drug Administration, ensuring the trial design, methods, and intended outcomes align with regulatory expectations. This comprehensive approach to development and validation demonstrates the company's commitment to evidence-based innovation in digital health.

The clinical validation of this smartphone-based screening tool represents a potential paradigm shift in sleep medicine, offering the possibility of early detection and monitoring capabilities to millions of people who might otherwise remain undiagnosed. As the trial progresses, its outcomes could significantly impact how sleep apnea is screened and managed globally, potentially transforming a smartphone into a powerful preventive health tool.

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