Actively Recruiting

Age: 18Years - 80Years
All Genders
ID05435794

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

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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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

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

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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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