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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Herbst oral appliance
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring prospective, randomized, polysomnography, orthodontic appliance, removable

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de ROUEN

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
June 25, 2013
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT00213434
Brief Title
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
Official Title
Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
prospective, randomized, polysomnography, orthodontic appliance, removable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Herbst oral appliance
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy on clinical symptoms
Title
Tolerance of the oral appliance
Title
Identification of predictive factors of efficacy
Title
Feasibility of this therapeutic method

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PORTIER PF Florence, MD
Organizational Affiliation
CHU de ROUEN
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de ROUEN
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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

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