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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01005940
Recruitment Status : Unknown
Verified March 2014 by Ulysses Magalang MD, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : November 1, 2009
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
Ulysses Magalang MD, Ohio State University

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices
Study Start Date : January 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.

Primary Outcome Measures :
  1. Treatment of OSA with mandibular advancement device results in improvements in insulin sensitivity [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01005940

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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ulysses Magalang MD
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Principal Investigator: Ulysses Magalang, M.D. Ohio State University
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Responsible Party: Ulysses Magalang MD, Professor-Clinical, Ohio State University Identifier: NCT01005940    
Other Study ID Numbers: 2009H0131
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by Ulysses Magalang MD, Ohio State University:
Sleep Apnea Syndromes
Insulin Resistance
Mandibular advancement device
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases