Obstructive Sleep Apnea Clinical Trials

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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.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Grenoble Alpes
RECRUITING
Grenoble
Contact Information
Primary
Marie JOYEUX-FAURE, Pr
MJoyeuxfaure@chu-grenoble.fr
+33(0)476767166
Time Frame
Start Date: 2026-06-10
Estimated Completion Date: 2029-09
Participants
Target number of participants: 105
Treatments
Other: PSG-SUN
Participants will first undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center. After this in-lab recording period, they will complete an at-home sleep assessment using the Sunrise device over the predefined home recording period.
Other: SUN-PSG
Participants will first complete an at-home sleep assessment using the Sunrise device over the predefined home recording period. After this home recording period, they will undergo an overnight, in-laboratory polysomnography (PSG) in the sleep center.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Grenoble
Collaborators: Polyclinique Saint Laurent - Rennes

This content was sourced from clinicaltrials.gov