Mandibular Advancement Device for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
Information provided by:
Nykøbing Falster County Hospital
ClinicalTrials.gov Identifier:
NCT00243139
First received: October 20, 2005
Last updated: September 14, 2006
Last verified: September 2006
  Purpose

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 Intervention Phase
Sleep Apnea Syndromes
Sleep Apnea
Obstructive Sleep Apnea
Device: Mandibular advancement device (activator)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Nykøbing Falster County Hospital:

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

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

Estimated Enrollment: 90
Study Start Date: July 1999
Estimated Study Completion Date: February 2004
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243139

Locations
Denmark
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
Investigators
Principal Investigator: Niels Petri, MD Nykoebing Falster County Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00243139     History of Changes
Other Study ID Numbers: SNB01
Study First Received: October 20, 2005
Last Updated: September 14, 2006
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Nykøbing Falster County Hospital:
Oral appliances
Obstructive sleep apnea
Epworth Sleepiness Scale
SF-36

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014