OSA-MAD: Dental Device for Treatment of Sleep Apnea

Sponsor

Ulysses Magalang MD (Other)

Overall Status

Completed

CT.gov ID

NCT01005940

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes	Device: Mandibular advancement device	N/A

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(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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity [16 weeks]

Secondary Outcome Measures

Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation [16 weeks]
Treatment of OSA with mandibular advancement device improves psychological adjustment. [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ulysses Magalang MD

Investigators

Principal Investigator: Ulysses Magalang, M.D., Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ulysses Magalang MD, Professor-Clinical, Ohio State University

ClinicalTrials.gov Identifier:

NCT01005940

Other Study ID Numbers:

2009H0131

First Posted:

Nov 1, 2009

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Ulysses Magalang MD, Professor-Clinical, Ohio State University

Sleep Apnea Syndromes

Insulin Resistance

Mandibular advancement device

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Study Results

No Results Posted as of Jul 23, 2021