Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring

Study Overview
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Brief Summary
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The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.

Detailed Description
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Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.

Official Title
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A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring

Conditions
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Sleep Apnea Syndromes, Snoring, Disorders of Excessive Somnolence

Intervention / Treatment
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* Device: Mandibular repositioning appliance, adjustable


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness Snoring with excessive daytime sleepiness, apnea-hypopnea index of <5 Body mass index of <35 Exclusion Criteria: Unable to give informed consent Psychiatric disorders including dementia that may interfere with the study protocol Other concomitant diseases that demand acute, effective treatment of sleep apnea Pharyngeal soft tissue abnormalities Living to far away from the University Hospital Professional drivers Pregnancy Included in other studies Other sleep apnea treatments Severe craniomandibular disorders Acute or advanced periodontal disease Insufficient number of teeth

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adjustable mandibular repositioning appliance | Device: Mandibular repositioning appliance, adjustable<br>* Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.<br>* Other names: Herbst appliance;|
| Placebo Comparator: 2<br>Placebo device in upper jaw | Device: Mandibular repositioning appliance, adjustable<br>* Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.<br>* Other names: Herbst appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep apnea and sleep measured by polysomnography |  | Baseline and after 4 months | 
| Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing |  | Baseline and after 4 months | 
| Quality of life |  | Baseline and after 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headaches |  | Baseline and after 4 months | 
| Blood pressure |  | Baseline and after 4 months | 
| Vigilance |  | Baseline and after 4 months | 
| Markers of stress |  | Baseline and after 4 months | 
| Markers of inflammation |  | Baseline and after 4 months | 
| Markers of cardiovascular health and oxidative stress |  | Baseline and after 4 months | 
| Side-effects from the treatment |  | After 4 months treatment | 
| Predictors of effects on symptoms and sleep apneas |  | After 4 months treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea syndromes, Snoring, Mandibular advancement, Activator appliances, Disorders of excessive somnolence, Blood pressure, Inflammation, Oxidative stress, Hormones, Markers of Metabolic Syndrome X