Dental Device for Treatment of Sleep Apnea (OSA-MAD)
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|ClinicalTrials.gov Identifier: NCT01005940|
Recruitment Status : Unknown
Verified March 2014 by Ulysses Magalang MD, Ohio State University.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2009
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndromes||Device: Mandibular advancement device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2014|
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.
- Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity [ Time Frame: 16 weeks ]
- Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation [ Time Frame: 16 weeks ]
- Treatment of OSA with mandibular advancement device improves psychological adjustment. [ Time Frame: 16 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005940
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ulysses Magalang, M.D.||Ohio State University|