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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219034
• Other study ID #: 2017-0390
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: March 20, 2019

Study information

• Verified date: January 2022
• Source: Texas A&M University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Texas A&M University College of Dentistry	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schneiderman E, Schramm P, Hui J, Wilson PD, Moura P, German Z, McCann A, Newton M. Randomized Trial of 2 Self-Titrated Oral Appliances for Airway Management. J Dent Res. 2021 Feb;100(2):155-162. doi: 10.1177/0022034520956977. Epub 2020 Sep 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Event Index (REI) at T2	Number of apneas and hypopneas (respiratory events) per hour of recording; REI was reported instead of AHI, as it is a more appropriate measure for home sleep testing.	4 weeks
Secondary	Stable Sleep Percent	Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis	4 weeks