Trial on Oral Appliance Design for Improving Upper Airway Function and Sleep Quality

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

This study will compare the effectiveness of the two leading oral appliances (OAs) designs for the treatment of severe obstructive sleep apnea in overweight adults. The effectiveness of OAs has come under question since different designs are combined in evaluating treatment efficacy, for example when comparing them to continuous positive airway pressure Due to the wide range of reported efficacy (53 to 90%), it is of great value to identify the most effective design to guide sleep practitioners and patients.

Key facts

Study ID

NCT03219034

Run by

Texas A&M University

People needed

62

Starts

2017-10-10

Expected to finish

2019-03-20

Last updated by the study team

2022-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• OSA PSG or PG diagnosed adults within 1 year
• age >18
• Currently treated with continuous positive airway pressure (CPAP)
• AHI ≥ >30 events/hour of sleep
• Two or more OSA symptoms (snoring, witnessed apnea or daytime hypersomnolence complaint)
• BMI ≥ 30
• At least 8 teeth per arch to support either OA device
• Central and mixed apnea index <5 events/hour
• Mallampati score from I to III
• Palatine tonsils - grade 0, 1, or 2
• Consent to study's timeline
• Willingness to wear home sleep test apparatus for at least 4 nights
• Willingness to wear an oral appliance every night for 8 weeks
• Willingness to pick up and return home sleep test kits as needed

You may not qualify if…

• Cardiac \& pulmonary disease (e.g., congestive heart failure, severe arrhythmias, COPD);
• Central sleep apnea;
• Comorbidities with other sleep disorders
• No active TMD or jaw muscle pain
• Morphological airway abnormalities
• Pre-existing difficulty swallowing; throat or neck related health issues
• Endocrine dysfunction
• Severe psychiatric disorders;
• Previous OA therapy; ENT surgery
• Restrictions in jaw opening
• Pregnancy / breast feeding or intent to become pregnant during the study
• Inability to apply the sleep recorders

Where it is running

• Texas A&M University College of Dentistry — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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