Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00213434 |
Recruitment Status
:
Completed
First Posted
: September 21, 2005
Last Update Posted
: June 26, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Device: Herbst oral appliance | Not Applicable |
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 |

- 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
- Efficacy on clinical symptoms
- Tolerance of the oral appliance
- Identification of predictive factors of efficacy
- Feasibility of this therapeutic method

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
CHU de ROUEN | |
Rouen, France, 76031 |
Principal Investigator: | PORTIER PF Florence, MD | CHU de ROUEN |
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 |