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OpenTrials
Completed

NCT Number: NCT01005940

Dental Device for Treatment of Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement device

Device

Mandibular advancement device made to subject specific specifications

Primary outcomes

  1. Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity

    Time frame: 16 weeks

Secondary outcomes

  1. Treatment of OSA with mandibular advancement device increases the levels of high-molecular-weight adiponectin in the circulation

    Time frame: 16 weeks

  2. Treatment of OSA with mandibular advancement device improves psychological adjustment.

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Ulysses Magalang MD

Other

Registry information

Official study title

Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

Acronym: OSA-MAD

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 2, 2009
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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