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Completed

NCT Number: NCT00243139

Mandibular Advancement Device for Obstructive Sleep Apnea

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nykoebing Falster County Hospital

Nykoebing Falster, Storstrøms County, DK-4800, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement device (activator)

Device

Primary outcomes

  1. Change in sleep parameters, especially apnea-hypopnea index (AHI).

Secondary outcomes

  1. Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.

  2. Change in quality of life, assessed by SF-36.

Sponsors and collaborators

Lead sponsor

Nykøbing Falster County Hospital

Other

Collaborators

  • Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
  • University of Copenhagen

Registry information

Official study title

A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea

Important dates

Study start
1999
Study completion
2004
First posted
Oct 21, 2005
Registry last updated
Sep 15, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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