Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT00213434
- Lead Sponsor
- University Hospital, Rouen
- Brief Summary
The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30)
- Body mass index (BMI) < 35 Kg/m2
- Able to give their informed consent
Exclusion Criteria
- Pregnant women
- Professional drivers requiring continuous positive airway pressure (CPAP) treatment
- Psychiatric disorders, and patients unable to realise to study
- Severe respiratory pathology which could interfere with the study
- Morpheic epilepsy
- Benzodiazepines intake
- Chronic nasal obstruction
- Ear, nose, and throat (ENT) pathology requiring surgery
- Previous uvulopalatoplasty surgery
- Temporomandibular joint pathology
- Gum disease
- Insufficient number of teeth to apply the oral appliance
- Mobile teeth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
- Secondary Outcome Measures
Name Time Method Efficacy on clinical symptoms Tolerance of the oral appliance Feasibility of this therapeutic method Identification of predictive factors of efficacy
Trial Locations
- Locations (1)
CHU de ROUEN
🇫🇷Rouen, France