FDA-Cleared Home Sleep Test Enables Multi-Night Diagnosis of Sleep Apnea

Clinicians need home-based diagnostics that can reliably capture respiratory effort and night-to-night variability without complex setups. A new rechargeable, multi-sensor at-home sleep apnea test with AI analysis now offers a clinically cleared option for multi-night testing.

Sunrise Group’s (Namur, Belgium) Sunrise Air home sleep test has received clearance from the U.S. Food and Drug Administration (FDA). The system is designed to complete the diagnostic pathway entirely at home using a single, ultra‑light, chin‑worn form factor. The company positions this generation as a step forward in expanding access to high‑quality sleep care.

The device measures mandibular jaw movements—a biosignal used for sleep assessment—and applies proprietary AI-supported algorithms to generate a clinician‑ready report. Building on this core signal, Sunrise Air integrates thermistors for airflow measurement, an optical module to capture oxygen saturation and pulse rate, and an embedded microphone for snoring analysis. Together, these data streams are analyzed to inform clinical review.

According to the announcement, these enhancements bolster respiratory event detection and assessment of respiratory effort and sleep fragmentation. The multimodal approach is described as supporting precise differentiation between central and obstructive apneas, including in clinically complex patients. The ergonomic, fully rechargeable design is intended to enable flexible multi‑night testing without disposable components, while maintaining a patient‑friendly setup.

“Sunrise has already set a new benchmark for home sleep testing through its high level of diagnostic accuracy even across complex sleep apnea phenotypes, including central sleep apnea, supported by its unique ability to measure respiratory effort,” said Laurent Martinot, CEO and Co‑founder of Sunrise.

“With a fully rechargeable model, we're unlocking what sleep medicine has always lacked: multi‑night insight with clinical‑grade accuracy, from the patient's bedside. Nobody sleeps the same way twice, yet we've been diagnosing based on a single night. That changes now. This isn't just a better diagnosis. It's world‑class sleep care, accessible to everyone,” added Martinot.

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