Mandibular Advancement Device for Obstructive Sleep Apnea

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. Identifier: NCT00243139
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : September 15, 2006
University of Copenhagen
Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
Information provided by:
Nykøbing Falster County Hospital

Brief Summary:
The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Sleep Apnea Obstructive Sleep Apnea Device: Mandibular advancement device (activator) Phase 2 Phase 3

Detailed Description:

Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.

In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea
Study Start Date : July 1999
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Primary Outcome Measures :
  1. Change in sleep parameters, especially apnea-hypopnea index (AHI).

Secondary Outcome Measures :
  1. Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
  2. Change in quality of life, assessed by SF-36.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • AHI > 5 on polysomnography
  • sufficient set of teeth to hold a splint
  • written informed consent

Exclusion Criteria:

  • sleep apnea with severe cardiovascular disease
  • other severe somatic or psychiatric disease
  • periodontal disease
  • significant occlusal dysfunction
  • pregnant women

Information from the National Library of Medicine

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 identifier (NCT number): NCT00243139

Nykoebing Falster County Hospital
Nykoebing Falster, Storstrøms County, Denmark, DK-4800
Sponsors and Collaborators
Nykøbing Falster County Hospital
University of Copenhagen
Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
Principal Investigator: Niels Petri, MD Nykoebing Falster County Hospital Identifier: NCT00243139     History of Changes
Other Study ID Numbers: SNB01
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: September 15, 2006
Last Verified: September 2006

Keywords provided by Nykøbing Falster County Hospital:
Oral appliances
Obstructive sleep apnea
Epworth Sleepiness Scale

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases