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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213434
• Other study ID #: 2000/055/HP
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 25, 2013
• Start date: November 2001
• Est. completion date: June 2006

Study information

• Verified date: June 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Herbst oral appliance

Locations

Country	Name	City	State
France	CHU de ROUEN	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy on clinical symptoms
Secondary	Tolerance of the oral appliance
Secondary	Identification of predictive factors of efficacy
Secondary	Feasibility of this therapeutic method