Mandibular Advancement Device for Obstructive Sleep Apnea

September 14, 2006 updated by: Nykøbing Falster County Hospital

A Randomized Controlled Trial of a 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Storstrøms County
      • Nykoebing Falster, Storstrøms County, Denmark, DK-4800
        • Nykoebing Falster County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Change in quality of life, assessed by SF-36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nykøbing Falster County Hospital

Collaborators

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

Investigators

  • Principal Investigator: Niels Petri, MD, Nykoebing Falster County Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Primary Completion

December 7, 2022

Study Completion

February 1, 2004

Study Registration Dates

First Submitted

October 20, 2005

First Submitted That Met QC Criteria

October 20, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2006

Last Update Submitted That Met QC Criteria

September 14, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNB01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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