Actively Recruiting
Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Device on the Sleep of Patients With Obstructive Sleep Apnea
Led by ResMed · Updated on 2024-05-21
400
Participants Needed
9
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are following 400 patients diagnosed with obstructive sleep apnea (OSA) across about ten sleep centers in France to study the long-term effects of two common treatments: continuous positive airway pressure (CPAP) and mandibular advancement device (MAD). The study focuses on how one year of treatment influences sleep quality and architecture, as well as patients' reported quality of life. The research also aims to identify factors that predict improvements in sleep quality during treatment. Participants will use either a fixed-pressure CPAP device, which includes remote monitoring capabilities, or a custom-made MAD created from dental impressions by a specialist. Sleep will be monitored at home using a connected sleep test device over one year. This observational study collects routine clinical data to compare the impact of these treatments on sleep patterns. Throughout the study, participants will undergo sleep tests with the Sunrise device and complete assessments of their sleep quality and life quality. The main outcome measured is the change in deep slow-wave sleep after one year of treatment. Researchers will also collect clinical information to understand how these treatments affect sleep over time and monitor participants to ensure ongoing safety and study adherence.
CONDITIONS
Brief Title
Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient already included in the SunSAS study or has had a sleep test eligible for CPAP or MAD treatment
- Patient with a sleep test performed with the Sunrise device
- Men or women aged 18 to 80 years
- Patient with obstructive sleep apnea syndrome eligible for CPAP or MAD therapy
- Affiliated with or beneficiary of a social security scheme
- Signed informed consent
You will not qualify if you...
- Patient previously treated for obstructive sleep apnea syndrome with CPAP or MAD in the last five years
- Patient with COPD or other respiratory diseases
- Patient with contraindications to CPAP or MAD therapy
- Patient with unstable heart disease or severe heart failure (New York Heart Association class III or IV)
- Patient unable to complete the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants who use CPAP or MAD devices for obstructive sleep apnea are observed to determine the evolution of sleep patterns over one year.
Periodic visits to assess sleep outcomes over 12 months
Trial Site Locations
Total: 9 locations
1
CHU Angers
Angers, France, 49933
Actively Recruiting
2
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France, 38043
Actively Recruiting
3
CHU Lyon - Hôpital de la Croix-Rousse
Lyon, France, 69004
Actively Recruiting
4
Hopital Europeen Marseille
Marseille, France, 13003
Actively Recruiting
5
APHP - Pitié-Salpêtrière University Hospital
Paris, France, 75013
Actively Recruiting
6
AP-HP Bichat
Paris, France, 75018
Not Yet Recruiting
7
CHU Reims
Reims, France, 51092
Actively Recruiting
8
Polyclinique St Laurent
Rennes, France
Actively Recruiting
9
Centre du Sommeil
Saint-Martin-d'Hères, France, 38400
Actively Recruiting
Research Team
E
Elodie Aversenq
F
Florent Lavergne
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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