Dental Device for Treatment of Sleep Apnea

Study Overview
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Brief Summary
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This study is being done to see if treatment of obstructive sleep apnea (OSA) with a mandibular advancement device (MAD) shows an increase in the quality of life. Many patients prefer to call them mandibular advancers, jaw advancers, jaw advancement splints, jaw advancement devices, anti-snoring mouthpieces, or oral appliances for the treatment of snoring and mild to moderate obstructive sleep apnea. The investigators will also see how helpful the mandibular advancement device is on insulin resistance.

Detailed Description
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Patients with obstructive sleep apnea (OSA) will be included in this prospective controlled trial. OSA patients who are unable to tolerate CPAP or refuse CPAP(Continuous positive airway pressure) (and who are deemed appropriate by their attending physician for dental device treatment of OSA will be randomized to a control group (no MAD treatment) or to active MAD therapy. Epidemiologic studies suggest that OSA is associated with insulin resistance independent of other known risk factors such as obesity. The cyclic intermittent hypoxia in OSA is the primary stimulus that leads to insulin resistance, a primary risk factor for the development of type 2 diabetes. There is an association between the level of hypoxic stress in OSA and insulin resistance. The overall hypothesis to be tested is that treatment of OSA with MAD will improve insulin sensitivity, increase levels of HMW (High-molecular- weight) adiponectin, and improve psychological adjustment.

Official Title
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Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Device: Mandibular advancement device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apnea-hypopnea index (AHI) of at least 20 events/hr based on overnight polysomnography > 18 years of age Unable to tolerate or refuse CPAP treatment Exclusion Criteria: Known diabetes mellitus Body mass index (BMI) > 45 kg/m2 Uncontrolled hypertension Known congestive heart failure Use of illicit drugs Excessive alcohol consumption, defined as: More than 3 glasses of wine a day More than 3 beers a day More than 60 mL of hard liquor a day Room air oxyhemoglobin saturation < 90% Use of home oxygen Use of corticosteroids Unable to give voluntary consent

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mandibular advancement device<br>Subject is evaluated when receiving intervention with mandibular advancement device. | Device: Mandibular advancement device<br>* Mandibular advancement device made to subject specific specifications<br>|
| No Intervention: No mandibular advancement device<br>Subject is evaluated when not receiving treatment with mandibular advancement device. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation |  | 16 weeks | 
| Treatment of OSA with mandibular advancement device improves psychological adjustment. |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea Syndromes, Insulin Resistance, Mandibular advancement device