Mandibular Advancement Device for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243139
• Other study ID #: SNB01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 20, 2005
• Last updated: September 14, 2006
• Start date: July 1999
• Est. completion date: February 2004

Study information

• Verified date: September 2006
• Source: Nykøbing Falster County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular advancement device (activator)

Locations

Country	Name	City	State
Denmark	Nykoebing Falster County Hospital	Nykoebing Falster	Storstrøms County

Sponsors (3)

Lead Sponsor	Collaborator
Nykøbing Falster County Hospital	Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep parameters, especially apnea-hypopnea index (AHI).
Secondary	Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Secondary	Change in quality of life, assessed by SF-36.