Dental Device for Treatment of Sleep Apnea (OSA-MAD)

Ulysses Magalang MD

Status

Completed

Conditions

Sleep Apnea Syndromes

Treatments

Device: Mandibular advancement device

Study type

Interventional

Funder types

Other

Identifiers

NCT01005940

2009H0131

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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