CompletedNot Applicable

Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome

FranceStarted 2001-11

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT00213434

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-12

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials