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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-06-17

No results posted yet for this 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.

Conditions

  • Sleep Apnea Syndrome, Obstructive

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Polyclinique Saint Laurent - Rennes

    collaborator UNKNOWN

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-10
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530302 on ClinicalTrials.gov