Sunrise Announces Landmark Results from the SUNSAS Trial, the Largest Randomized Controlled Study of an At-Home Sleep Apnea Diagnostic Pathway Compared with PSG

NEW YORK--(BUSINESS WIRE)--Sunrise Group, a pioneer in medical device innovation and sleep care, today announced results from the SUNSAS clinical study, now published in The Lancet Regional Health – Europe, a leading international medical journal. Supported by the French Ministry of Health through the Forfait Innovation program, this study is the largest randomized controlled trial to date evaluating an at-home diagnostic pathway for obstructive sleep apnea (OSA) compared with gold-standard polysomnography (PSG).

OSA affects more than 900 million people worldwide, making it a major global health challenge. SUNSAS evaluated whether a diagnostic pathway built around Sunrise’s technology could streamline access to diagnosis and treatment while maintaining clinical effectiveness.

Sunrise provides an alternative to traditional sleep testing by using a single, ultra-light chin-worn sensor for at-home use, with versions supporting multi-night assessment. The device captures mandibular jaw movements – a clinically validated biosignal for sleep assessment – and analyzes the data using proprietary AI-supported algorithms to generate a comprehensive sleep report for clinician review.

Conducted between 2021 and 2024 under the coordination of Professor Jean-Louis Pépin, a world-renowned expert in sleep medicine, the trial enrolled 849 adults across 18 sleep centers in France. Participants were randomized to diagnosis using either traditional PSG or Sunrise’s at-home sleep test, allowing a direct comparison of the two diagnostic pathways in routine clinical practice.

Key findings from the SUNSAS study include:

• A diagnosis in days, not months: Sunrise participants received a diagnosis in just 15 days, versus a wait time of over 106 days with PSG. A 7-fold acceleration.
• A faster access to treatment: Sunrise cut the time to treatment from 124 to 50 days, allowing patients to begin therapy more than twice as fast.
• An improvement in clinical outcomes: Sunrise was as effective as PSG in reducing daytime sleepiness three months after diagnosis. Earlier treatment initiation in the Sunrise group was associated with greater improvements in daytime sleepiness, quality of life, and work productivity three months after study entry.

Together, these findings suggest that Sunrise may contribute to sleep apnea diagnostic pathways by supporting testing outside traditional sleep laboratory settings and helping extend access to care in a range of healthcare environments.

“Publication in The Lancet Regional Health – Europe highlights the scientific rigor and reliability of the study findings,” said Professor Jean-Louis Pépin, coordinating investigator of SUNSAS and Professor of Sleep Medicine at the Grenoble Alpes University. “By reducing waiting times to diagnosis and treatment without compromising patient outcomes, the Sunrise diagnostic pathway may offer a pragmatic solution to support access to timely management in routine clinical practice, an important step forward for sleep medicine.”

“SUNSAS was made possible through the strong commitment of the participating sleep centers, whose physicians and site staff played a central role in the successful conduct of the study and in generating high-quality evidence in sleep apnea diagnosis. The rigor of the statistical analyses conducted by the independent academic team at the Grenoble Clinical Investigation Center (CIC) underscores the scientific robustness of the results,” said Laurent Martinot, Co-Founder and CEO of Sunrise Group. “Conducted within the framework of the Forfait Innovation program, SUNSAS provides pivotal data needed to guide reimbursement discussions and support broader integration of Sunrise into routine clinical practice internationally.”

This announcement comes on the heels of Sunrise’s $29M raise, which supports the expansion of the company’s clinical services, particularly through Dreem Health, the U.S.-based virtual sleep clinic, and accelerates investment in next-generation sleep technology. Sunrise is building advanced software and hardware to improve how sleep disorders are detected, monitored, and treated, with the goal of making sleep care faster, easier, and accessible to anyone, anywhere.

About the Sunrise Group

Founded in 2015, Sunrise Group® is a pioneer in medical device innovation and sleep care. The company first developed an FDA-cleared and CE-marked medical device – a lightweight, chin-worn sensor for at-home sleep apnea diagnosis using AI-supported analysis of mandibular jaw movements – that has been validated in peer-reviewed studies and endorsed by leading sleep experts. Today, Sunrise builds on that breakthrough to develop advanced software and hardware to detect, monitor, and treat sleep disorders, and brings this expertise to Dreem Health®, the U.S.-based virtual sleep clinic available in all 50 states and covered by major insurers. Headquartered in Belgium with offices in France and the United States, the team brings together leaders in sleep research, patient care, and medical technology. To learn more about Sunrise and Dreem Health, visit us.hellosunrise.com and dreemhealth.com.

About the SUNSAS Study

The SUNSAS study is a large, randomized controlled clinical trial conducted across France to evaluate an at-home diagnostic pathway for OSA using the Sunrise device compared with gold-standard PSG. The study was supported by the French Ministry of Health through the Forfait Innovation program, a national initiative that enables early access to promising innovative medical technologies, contingent upon the generation of high-level clinical and economic evidence to inform reimbursement decisions. In this context, SUNSAS was designed to assess whether Sunrise’s end-to-end home diagnostic solution, using AI-supported analysis of mandibular jaw movements, could shorten the time to OSA diagnosis and treatment and, in turn, enable timely improvements in patient-reported outcomes.