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

NCT ID: NCT00213434

Last Updated: 2013-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Herbst oral appliance

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PORTIER PF Florence, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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CHU de ROUEN

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2000/055/HP

Identifier Type: -

Identifier Source: org_study_id

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