The new rechargeable home sleep test integrates more sensors than the original, including thermistors, an optical module, and a mic.
Key takeaways:
- Sunrise Air is a fully rechargeable, chin-worn home sleep test designed for multi-night use.
- The device combines mandibular jaw movement tracking with airflow thermistors, an optical module, and a microphone to differentiate between central and obstructive apneas.
- The FDA clearance follows a $29 million funding round aimed at expanding Sunrise’s clinical services, including its US-based virtual sleep clinic, Dreem Health.
The US Food and Drug Administration (FDA) has cleared Sunrise Air, the next generation of home sleep test (HST) developed by Sunrise Group.
Like the original design, the new Sunrise Air diagnostic tool is designed as a simple at-home solution built around a chin-worn sensor. It records mandibular jaw movements (MJM) and analyzes the data through proprietary artificial intelligence (AI)-supported algorithms to generate a sleep report for clinician review.
With Sunrise Air, the company builds on its mandibular jaw movements technology by integrating additional sensors, including thermistors for airflow, an optical module for oxygen saturation and pulse rate, and an embedded microphone for snoring analysis. According to the company, these enhancements strengthen respiratory event detection and the assessment of respiratory effort and sleep fragmentation, supporting precise differentiation between central and obstructive apneas.
According to FDA clearance documents, Sunrise Air’s newly integrated thermistor and microphone demonstrated equivalent performance to reference devices in capturing breathing and snoring patterns. Additionally, while the device’s raw photoplethysmography data acquisition remains identical to the previous generation, data processing has transitioned to a cloud-based algorithm. Clinical validation of this optical module showed a blood oxygen saturation (SpO₂) accuracy of 1.91% over a 70% to 100% range, alongside a pulse rate accuracy of 2.73 beats per minute.
Sunrise Air is fully rechargeable, enabling flexible multi-night testing without disposable components.
“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,” says Laurent Martinot, CEO and co-founder of Sunrise, in a release. “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.”
