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
  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:


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
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

No publications provided

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014