Status:
COMPLETED
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Lead Sponsor:
University Hospital, Rouen
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Moderate sleep apnea syndrome (10 \< Respiratory Disorder Index \< 30)
- Body mass index (BMI) \< 35 Kg/m2
- Able to give their informed consent
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00213434
Start Date
November 1 2001
End Date
June 1 2006
Last Update
June 26 2013
Active Locations (1)
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1
CHU de ROUEN
Rouen, France, 76031