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.
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
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
University Hospital, Grenoble
Lead sponsor
Polyclinique Saint Laurent - Rennes
Collaborator