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

Obstructive Sleep Apnea Clinical Trial

Official title: Mid-line Traction Versus Bilateral Thrust Oral Appliances: A Trial to Determine Superiority for Improving Upper Airway Function and Sleep Quality

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

The two prominent oral appliances used in treating obstructive sleep apnea differ in their designs, mid-line traction versus bilateral thrust. From a clinical perspective, it is important to know which design is superior and should be the 'treatment of choice' for improving airway function and sleep quality. These two designs differ in their protrusive mechanisms that are categorized in general under four main types: bilateral compression, bilateral thrust, midline compression and mid-line traction. Although the two designs considered in this proposal have undergone the most rigorous testing individually, well controlled 'head-to-head' trials as proposed here have not been conducted to determine their efficacy within a single test population. ;

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT03219034
• Study type: Interventional
• Source: Texas A&M University
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Completion date: March 20, 2019