Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

University Hospital, Rouen1 site in 1 countryNovember 2001

ConditionsObstructive Sleep Apnea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obstructive Sleep Apnea
Sponsor: University Hospital, Rouen
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2001

End Date

June 2006

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Rouen

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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