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

This study is currently recruiting participants.

Verified by University Hospital, Rouen, September 2005

First Received: September 13, 2005 Last Updated: June 23, 2006 History of Changes

Sponsored by:	University Hospital, Rouen
Information provided by:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213434

Purpose

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.

Condition	Intervention
Obstructive Sleep Apnea	Device: Herbst oral appliance

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

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 Outcome Measures:

Efficacy on clinical symptoms
Tolerance of the oral appliance
Identification of predictive factors of efficacy
Feasibility of this therapeutic method

Study Start Date:

November 2001

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Gum disease
Insufficient number of teeth to apply the oral appliance
Mobile teeth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213434

Contacts

Contact: PORTIER PF Florence, MD

florence.portier@chu-rouen.fr

Locations

France
CHU de ROUEN	Recruiting
ROUEN, France, 76031
Contact: PORTIER PF FLORENCE, MD 33 2 3288 90 83 florence.portier@chu-rouen.fr

Sponsors and Collaborators

University Hospital, Rouen

Investigators

Principal Investigator:

PORTIER PF Florence, MD

CHU de ROUEN

More Information

No publications provided

Study ID Numbers:	2000/055 HP
Study First Received:	September 13, 2005
Last Updated:	June 23, 2006
ClinicalTrials.gov Identifier:	NCT00213434 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

prospective
randomized
polysomnography
orthodontic appliance, removable

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 07, 2009