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

This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ulysses Magalang MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01005940
First received: October 30, 2009
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Outcomes of Treatment of Obstructive Sleep Apnea With Dental Devices

Resource links provided by NLM:

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 ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  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

Contacts
Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu
Contact: Melissa Michetti 614-366-2761 melissa.michetti@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact     614-293-4978     Lung.Research@osumc.edu    
Sponsors and Collaborators
Ulysses Magalang MD
Investigators
Principal Investigator: Ulysses Magalang, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Ulysses Magalang MD, Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier: NCT01005940     History of Changes
Other Study ID Numbers: 2009H0131
Study First Received: October 30, 2009
Last Updated: May 13, 2013
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
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013