Clinical Trial

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.

Study acronym: SUNCPAP
Recruiting
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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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-06-18
notable Primary completion pushed: 2028-09 -> 2029-09 2026-06-18
minor Completion pushed: 2028-09 -> 2029-09 2026-06-18
Trial Details
NCT Number NCT07530302
Lead Sponsor University Hospital, Grenoble
Collaborators: Polyclinique Saint Laurent - Rennes
Conditions Sleep Apnea Syndrome, Obstructive
Enrollment 105 participants
Start Date 2026-06-10
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-17