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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT00213434

First received: September 13, 2005

Last updated: June 25, 2013

Last verified: June 2013

History of Changes

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
Study Completion Date:	June 2006
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


France
CHU de ROUEN
Rouen, France, 76031

Sponsors and Collaborators

University Hospital, Rouen

Investigators


Principal Investigator:	PORTIER PF Florence, MD	CHU de ROUEN

More Information


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:	June 25, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 Wake Disorders Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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