Dental Device for Treatment of Sleep Apnea

NCT01005940 | Completed DMC FDA Device

• 1 other identifier: 2009H0131
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea Syndromes; Insulin Resistance; Mandibular advancement device

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Mandibular advancement device

EXPERIMENTAL

Subject is evaluated when receiving intervention with mandibular advancement device.

Device: Mandibular advancement device

No mandibular advancement device

NO INTERVENTION

Subject is evaluated when not receiving treatment with mandibular advancement device.

Interventions

Mandibular advancement device DEVICE

Mandibular advancement device made to subject specific specifications

Mandibular advancement device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulysses Magalang MD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Insulin Resistance

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Ulysses Magalang, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor-Clinical

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 30, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)