NCT00213434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

3.1 years

First QC Date

September 13, 2005

Last Update Submit

June 25, 2013

Conditions

Obstructive Sleep Apnea

Keywords

prospectiverandomizedpolysomnographyorthodontic appliance, removable

Outcome Measures

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 (4)

  • Efficacy on clinical symptoms

  • Tolerance of the oral appliance

  • Identification of predictive factors of efficacy

  • Feasibility of this therapeutic method

Interventions

Herbst oral applianceDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate sleep apnea syndrome (10 \< Respiratory Disorder Index \< 30)
  • Body mass index (BMI) \< 35 Kg/m2
  • Able to give their informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de ROUEN

Rouen, 76031, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • PORTIER PF Florence, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

November 1, 2001

Primary Completion

December 1, 2004

Study Completion

June 1, 2006

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

FR(1)