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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 23, 2006

Start Date ^ICMJE

November 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 placebo group.

Change History

Complete list of historical versions of study NCT00213434 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

Device: Herbst oral appliance

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: PORTIER PF Florence, MD

florence.portier@chu-rouen.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00213434

Responsible Party

Study ID Numbers ^ICMJE

2000/055 HP

Study Sponsor ^ICMJE

University Hospital, Rouen

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

PORTIER PF Florence, MD

CHU de ROUEN

Information Provided By

University Hospital, Rouen

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP