NCT07530302

Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.

Treatment Failure of Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea Syndrome (OSA): A Randomized Controlled Trial Comparing Polysomnography and the Sunrise Device to Drive Treatment-Adjustment Decisions.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine whether treatment-adjustment decisions based on one night of home monitoring with the Sunrise device are comparable to decisions based on one night of in-laboratory polysomnography (PSG) in adults with obstructive sleep apnea (OSA) who remain insufficiently controlled with continuous positive airway pressure (CPAP) therapy. The main questions it aims to answer are: * Do Sunrise-based assessments lead to similar therapeutic decisions as PSG-based assessments? * Are residual apnea-hypopnea indices measured by Sunrise comparable to those measured by PSG? Participants will complete both assessment sequences in a randomized cross-over design. They will: * Use the Sunrise device for several nights with and without CPAP. * Undergo one night of PSG with and without CPAP. * Have their CPAP therapy reviewed based on the results of each assessment method.

Detailed description

Obstructive sleep apnea (OSA) affects nearly one billion adults worldwide and is associated with recurrent upper-airway obstruction during sleep, leading to intermittent hypoxemia and multiple cardiometabolic and neurocognitive comorbidities. Continuous positive airway pressure (CPAP) is the standard treatment and is widely prescribed, with more than 1.8 million users in France. Despite its proven efficacy, large-scale analyses show that over 10% of treated patients continue to exhibit elevated residual apnea-hypopnea indices (AHI), a situation associated with reduced adherence and premature discontinuation of therapy. Evaluation of CPAP effectiveness typically relies on in-laboratory polysomnography (PSG), which remains the reference method for characterizing residual respiratory events and sleep architecture. However, the need for PSG generates substantial healthcare costs, long waiting times, and unequal access to diagnostic resources. The Sunrise device is a CE-marked medical device that records mandibular movements during sleep and uses artificial intelligence to characterize respiratory events and sleep parameters. Multiple validation studies have demonstrated strong agreement between Sunrise-derived metrics and PSG. This randomized cross-over trial investigates whether Sunrise can be used to guide therapeutic decisions in patients with insufficiently controlled OSA under CPAP therapy, defined by a residual AHI greater than 10 events per hour. Participants are randomized to one of two sequences: 1. Sunrise assessments first, consisting of several nights with and without CPAP, followed by one night of PSG with and without CPAP; or 2. PSG assessments first, followed by the Sunrise sequence. This design allows each participant to serve as their own control and enables direct comparison of treatment-adjustment decisions derived from Sunrise versus PSG. The study aims to determine whether a home-based, low-burden assessment could replace or reduce the need for in-laboratory evaluations, thereby improving access to care, reducing costs, and facilitating personalized CPAP management.

Conditions

• Sleep Apnea Syndrome, Obstructive

Interventions

Type	Name	Description
DEVICE	Sunrise	The Sunrise device is a single-use, mandibular movement-based sleep monitoring sensor designed to assess sleep architecture and respiratory events at home. In this study, Sunrise is evaluated as an alternative to in-laboratory polysomnography (PSG), which is considered the current gold-standard reference for sleep assessment.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2026-04-15
• Last updated: 2026-04-15