Dental Device for Treatment of Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | January 2010 |
| End Date: | December 2014 |
| Contact: | Pulmonary Clinical Trials Office |
| Email: | Lung.Research@osumc.edu |
| Phone: | 614-293-4978 |
Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices
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.
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.
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.
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
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