AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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.

RecruitingNAAges 18 Years - 85 YearsAllUniversity Hospital, Grenoble
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
๐Ÿ’Š

What it tests

  • Sunrise
๐Ÿ“

Where

1 site
CHU Grenoble Alpes
Grenoble, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy