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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular advancement device | Experimental | Subject is evaluated when receiving intervention with mandibular advancement device. |
|
| No mandibular advancement device | No Intervention | Subject is evaluated when not receiving treatment with mandibular advancement device. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular advancement device | Device | Mandibular advancement device made to subject specific specifications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity | 16 weeks |
| 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 |
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Inclusion Criteria:
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:
Room air oxyhemoglobin saturation < 90%
Use of home oxygen
Use of corticosteroids
Unable to give voluntary consent
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| Name | Affiliation | Role |
|---|---|---|
| Ulysses Magalang, M.D. | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |