RecruitingNot ApplicableNCT07530302

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.

Sponsor

University Hospital, Grenoble

Enrollment

105 participants

Start Date

Jun 10, 2026

Study Type

INTERVENTIONAL

Conditions

Sleep Apnea Syndrome, Obstructive

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

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

Exclusion Criteria9

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

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Interventions

DEVICESunrise

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.