NCT05435794 Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
| NCT ID | NCT05435794 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ResMed |
| Condition | OSA |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-07-15 |
| Primary Completion | 2022-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-07-15 with a primary completion date of 2022-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.
Eligibility Criteria
Inclusion Criteria: * Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA. * Patient with a sleep test performed with the Sunrise device * Men or Women from 18 to 80 years old * Patient with OSAS eligible for CPAP or MAD therapy * Affiliated patient or beneficiary of a social security scheme * Signed informed consent Exclusion Criteria: * Patient previously treated for OSAS by CPAP or MAD during the last five years * Patient with COPD or other respiratory diseases. * Patient with contraindications to PPC or MAD therapy * Patient with unstable heart disease or New York Heart Association class III or IV heart failure * Patient unable to complete the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05435794 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying OSA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05435794 currently recruiting?
Yes, NCT05435794 is actively recruiting participants. Contact the research team at elodie.aversenq@resmed.fr for enrollment information.
Where is the NCT05435794 trial being conducted?
This trial is being conducted at Angers, France, Grenoble, France, Lyon, France, Marseille, France and 5 additional locations.
Who is sponsoring the NCT05435794 clinical trial?
NCT05435794 is sponsored by ResMed. The trial plans to enroll 400 participants.