Overview

This trial is active, not recruiting.

Condition sleep apnea syndromes
Treatment mandibular advancement device
Sponsor Ulysses Magalang MD
Start date January 2010
End date June 2014
Trial size 40 participants
Trial identifier NCT01005940, 2009H0131

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Subject is evaluated when receiving intervention with mandibular advancement device.
mandibular advancement device
Mandibular advancement device made to subject specific specifications
(No Intervention)
Subject is evaluated when not receiving treatment with mandibular advancement device.

Primary Outcomes

Measure
Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
time frame: 16 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices
Principal investigator Ulysses Magalang, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Ohio State University.