Obstructive Sleep Apnea
Conditions
Keywords
prospective, randomized, polysomnography, orthodontic appliance, removable
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.
Interventions
DEVICEHerbst oral appliance
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Efficacy on clinical symptoms | — |
| Tolerance of the oral appliance | — |
| Identification of predictive factors of efficacy | — |
| Feasibility of this therapeutic method | — |
Countries
France
Outcome results
None listed