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Completed

NCT Number: NCT00213434

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de ROUEN

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbst oral appliance

Device

Primary outcomes

  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 outcomes

  1. Efficacy on clinical symptoms

  2. Tolerance of the oral appliance

  3. Identification of predictive factors of efficacy

  4. Feasibility of this therapeutic method

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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