Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

Sunrise device vs PSG to guide CPAP decisions in adults with obstructive sleep apnea

Official title: 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.

Run by University Hospital, Grenoble · NCT07530302 · Data updated 2026-11-12

We are testing whether using the Sunrise home-monitoring device can guide CPAP treatment decisions as well as the standard overnight lab PSG in adults with obstructive sleep apnea whose CPAP still isn’t fully controlling their condition.

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment105 (estimated)
SponsorUniversity Hospital, Grenoble
Academic / other
Locations1 site (Grenoble)
StatusRecruiting
StartedJune 10, 2026
Main results expectedSeptember 2029
Study endsSeptember 2029
Registry record updatedJune 17, 2026
Trial IDNCT07530302 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 to 85 with obstructive sleep apnea on Resmed CPAP who have residual AHI greater than 10 per hour and have smartphone/internet access.

Probably not a fit

Patients whose sleep-disordered breathing is not adequately captured by Sunrise metrics or whose CPAP needs cannot be appropriately managed without PSG may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized cross-over study compares one-night Sunrise-based assessments to one-night in-lab polysomnography (PSG) for guiding CPAP therapy adjustments in adults with obstructive sleep apnea who have residual events on CPAP. Participants undergo both Sunrise and PSG assessments, with and without CPAP, and CPAP therapy is reviewed based on each method’s results. Sunrise records mandibular movements and uses AI to derive sleep and breathing metrics, which are then evaluated against PSG-derived metrics to determine if treatment decisions align. The trial addresses whether Sunrise can provide similar residual AHI and other sleep parameter information as PSG, potentially offering a cost-effective, accessible alternative for monitoring CPAP efficacy.

Why it matters

Potential benefit: If successful, Sunrise-guided decisions could streamline follow-up visits, reduce the need for overnight PSG, and improve access to CPAP optimization.

How similar studies have gone: Previous validation studies show strong agreement between Sunrise-derived metrics and PSG, but this is among the first randomized cross-over trials using Sunrise to guide CPAP treatment decisions.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • CHU Grenoble Alpes
    Grenoble, France
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.