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

July 28, 2025 updated by: Ulysses Magalang MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation
Time Frame: 16 weeks
16 weeks
Treatment of OSA with mandibular advancement device improves psychological adjustment.
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulysses Magalang MD

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimated)

November 1, 2009

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009H0131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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