Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome

Hopital Foch4 enrolled

Overview

Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Herbst (propulsion type oral appliance)DEVICE

Oral appliance

Retention type appliance (ORM)DEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sufficient teeth to allow wearing of the device * Mild to severe OSAS * Ability to answer the questionnaires * No concomitant CPAP treatment * BMI inferior to 32 kg/m2 Exclusion Criteria: * Important dental or parodontal disease * Central sleep apnea * Jaw opening limitations * Temporo-mandibular joint dysfunction * Major gag reflex precluding the long-term use of the device * Major or unstable cardiovascular or pulmonary disease

Locations (1)

Hôpital FOCH

Suresnes, France

Outcomes

Primary Outcomes

Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)

Time frame: 12 months

Data from ClinicalTrials.gov

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