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.
Recruiting now · Not applicable
Conditions studied: Sleep Apnea Syndrome, Obstructive
In brief
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.
Key facts
- Study ID
- NCT07530302
- Run by
- University Hospital, Grenoble
- People needed
- 105
- Starts
- 2026-06-10
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18 to 85 years
- Patients treated with Resmed CPAP
- Residual apnea-hypopnea index under CPAP (rAHI(CPAP) > 10 events/hour)
- Access to a smartphone and home internet connection, and ability to use a mobile application
- Signed informed consent
- Affiliated with, or beneficiary of, a national health insurance program
You may not qualify if…
- Severe chronic obstructive or restrictive pulmonary disease, with or without supplemental oxygen
- Unstable cardiovascular disease or severe heart failure requiring hospitalization within the past 3 months, or meeting New York Heart Association (NYHA) class III or IV criteria
- Conditions affecting mandibular condyle rotation or temporomandibular joint function
- Refusal to shave excessive facial hair when required for proper placement of the Sunrise device
- Participation in another interventional clinical study or currently within an exclusion period of another study
- Individuals who, in the investigator's judgment, are unlikely to comply with study procedures or requirements
- Individuals who cannot be contacted in case of emergency
- Persons protected under French Public Health Code articles L1121-5, L1121-6, and L1121-8 (including pregnant or breastfeeding women, persons deprived of liberty, individuals under psychiatric care under articles L.3212-1 or L.3213-1, individuals admitted to healthcare or social institutions for reasons other than research, and persons under legal protection or unable to provide informed consent)
- Staff members with a hierarchical relationship to the principal investigator
Where it is running
- CHU Grenoble Alpes — Grenoble, France (enrolling)
Full record on ClinicalTrials.gov
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