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

University Hospital, Rouen

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Obstructive Sleep Apnea

Interventions

Herbst oral applianceDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de ROUEN

Rouen, France

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

Secondary Outcomes

Efficacy on clinical symptoms

Tolerance of the oral appliance

Identification of predictive factors of efficacy

Feasibility of this therapeutic method

Data from ClinicalTrials.gov

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