How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Completed
- Conditions
- Sleep Apnea, ObstructiveRespiratory Tract DiseasesSleep Apnea Syndromes
- Registration Number
- NCT05056766
- Lead Sponsor
- Centre Hospitalier de Valence
- Brief Summary
The OAMMM study is a mono-centrer , non interventional, prospective study, carried out in CH Valence
Oral Appliance is indicated for first line moderate sleep Apnea Syndrome or severe sleep Apnea Syndrome after failure of positive airway pressure (CPAP).
Clinical impact of each mm advancement of Oral Appliance is imperfectly assessed.
The study aim to assess clinical and paraclinical efficacy of an oral Appliance on each mm of advancement.
- Detailed Description
Oral appliance will be delivered with a propulsion at 50% of the maximum advance and the investigator will titrate the advance according to the usual method
Polygraphy and clinical effectiveness of the Oral appliance will be evaluate
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Age ā„ 18 years old
- Moderate sleep apnea diagnosis with clinical signs
- Severe sleep apnea with failure continuous positive airway pressure( CPAP)
Exclusion Criteria
- previous sleep apnea treatment for Moderate sleep apnea
- refusal to participate in research
- Patient under guardianship, deprived of liberty, safeguard of justice
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method apnea-hypopnea index 6 months severity of sleep apnea
- Secondary Outcome Measures
Name Time Method pichot fatigue questionnaire 6 months Epworth Sleepiness Scale score 6 months
Trial Locations
- Locations (1)
CH Valence
š«š·Valence, France