Mandibular Advancement Device for Obstructive Sleep Apnea

Study Overview
=================
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.

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.

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

Conditions
-----------------
Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Mandibular advancement device (activator)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mandibular advancement device (activator)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36