NCT03219034

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Texas A&M University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	oral appliance - A ; washout; oral appliance B	Anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible. 1 week washout followed by anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.
DEVICE	oral appliance - B; washout; oral appliance A	Anti-snoring intra-oral appliance B that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs. 1-week washout followed by anti-snoring intra-oral appliance A that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.

Timeline

• Start date: 2017-10-10
• Primary completion: 2019-03-20
• Completion: 2019-03-20
• First posted: 2017-07-17
• Last updated: 2022-01-10
• Results posted: 2022-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study