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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient treated with CPAP |
| ||
| Patient treated with MAD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Fixed-pressure CPAP device for the treatment of sleep apnea with optional humidification and heated circuit. This device is a Class II device. It has a remote monitoring function allowing service providers to track the use of the device. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD). | Objective evolution of deep slow-wave sleep time. Changes collected with a home-connected sleep testing device by comparing data from the initial visit (diagnosis) with data collected at 12 months (± 2 weeks) in a patient treated with CPAP or MAD. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elodie Aversenq | Contact | +33426100200 | elodie.aversenq@resmed.fr | |
| Florent Lavergne | Contact | +33426100200 | florent.lavergne@resmed.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Recruiting | Angers | 49933 | France |
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| MAD | Device | mandibular device orthosis made to measure from the dental impressions of patients, made by the specialist in the masticatory apparatus for the treatment of sleep apnea. |
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| Centre Hospitalier Universitaire Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
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| CHU Lyon - Hôpital de la Croix-Rousse | Recruiting | Lyon | 69004 | France |
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| Hopital Europeen Marseille | Recruiting | Marseille | 13003 | France |
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| APHP - Pitié-Salpêtrière University Hospital | Recruiting | Paris | 75013 | France |
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| AP-HP Bichat | Not yet recruiting | Paris | 75018 | France |
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| CHU Reims | Recruiting | Reims | 51092 | France |
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| Polyclinique St Laurent | Recruiting | Rennes | France |
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| Centre du Sommeil | Recruiting | Saint-Martin-d'Hères | 38400 | France |
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