Dental Device for Treatment of Sleep Apnea (OSA-MAD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices|
- Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Treatment of OSA with mandibular advancement device improves psychological adjustment. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Mandibular advancement device
Subject is evaluated when receiving intervention with mandibular advancement device.
Device: Mandibular advancement device
Mandibular advancement device made to subject specific specifications
No Intervention: No mandibular advancement device
Subject is evaluated when not receiving treatment with mandibular advancement device.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005940
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ulysses Magalang, M.D.||Ohio State University|