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

This study is currently recruiting participants.

Verified August 2011 by University Hospital, Rouen

First Received on September 13, 2005. Last Updated on August 23, 2011 History of Changes

Sponsor:	University Hospital, Rouen
Information provided by (Responsible Party):	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT00213434 History of Changes
Other Study ID Numbers:	2000/055 HP
Study First Received:	September 13, 2005
Last Updated:	August 23, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Rouen:

prospective
randomized
polysomnography
orthodontic appliance, removable

Additional relevant MeSH terms:

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

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012