Dental Device for Treatment of Sleep Apnea - Full Text View

Sponsor:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT01005940

Purpose

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.

Condition	Intervention
Sleep Apnea Syndromes	Device: Mandibular advancement device Other: No mandibular advancement device

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	October 2009
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mandibular advancement device: Experimental Subject is evaluated when receiving intervention with mandibular advancement device.	Device: Mandibular advancement device Mandibular advancement device made to subject specific specifications
No mandibular advancement device: No Intervention Subject is evaluated when not receiving treatment with mandibular advancement device.	Other: No mandibular advancement device Subject does not get the mandibular advancement device and is tested for the same duration as the subject with the mandibular advancement device.

Detailed 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 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 adiponectin, and improve psychological adjustment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005940

Locations

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

Ulysses Magalang, M.D.

Ohio State University

More Information

No publications provided

Responsible Party:	The Ohio State University ( Ulysses J. Magalang M.D. )
Study ID Numbers:	2009H0131, OSA-MAD
Study First Received:	October 30, 2009
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT01005940 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Sleep Apnea Syndromes
Insulin Resistance
Mandibular advancement device

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Disease
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Nervous System Diseases
Dyssomnias

Sleep Disorders
Sleep Disorders, Intrinsic
Signs and Symptoms
Pathologic Processes
Respiratory Tract Diseases
Syndrome
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on February 08, 2010