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

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ClinicalTrials.gov Identifier: NCT00213434
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Herbst oral appliance Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
Study Start Date : November 2001
Actual Primary Completion Date : December 2004
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Efficacy on clinical symptoms
  2. Tolerance of the oral appliance
  3. Identification of predictive factors of efficacy
  4. Feasibility of this therapeutic method

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00213434     History of Changes
Other Study ID Numbers: 2000/055/HP
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

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