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.

NCT07530302 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Grenoble

Phase

Not applicable

Started

2026-06-10

Last updated

2026-06-17

Condition(s) studied

Sleep Apnea Syndrome, Obstructive

Investigational drug(s) / intervention(s)

Sunrise

Sunrise: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

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

Primary outcome measure(s)

Cohen's Kappa for Agreement Between Therapeutic Adjustment Decisions Based on Sunrise and Polysomnography (PSG) — Within 1 night for each modality (Sunrise home recording and in-lab PSG).
Agreement between therapeutic adjustment decisions derived from Sunrise home recordings and in-lab polysomnography (PSG), quantified using Cohen's kappa coefficient. Two independent experts will provide decisions for each modality; disagreements will be resolved by consensus. The therapeutic decision is a three-category variable: No change in CPAP treatment, adjustment of CPAP pressure or change of mask, switch to servo-ventilation if residual events are predominantly central.

Trial sites (1)

Facility	City	Region	Status
CHU Grenoble Alpes	Grenoble	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07530302 on ClinicalTrials.gov ↗ ← All trials in France