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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: oral appliance - A ; washout; oral appliance B; Device: oral appliance - B; washout; oral appliance A

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas A&M University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral appliance - A; Anti-snoring intra-oral appliance 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. Trade Name: "TAP1" Oral Appliance, Airway Management Inc. Dallas, TX	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.; Other Names: "TAP1" Oral Appliance; washout; "SomnoDent Flex"; 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.; Other Names: "SomnoDent Flex"; washout; "TAP1"
Experimental: Oral appliance - B; Anti-snoring intra-oral appliance 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. Trade name: "SomnoDent Flex" Oral Appliance, SomnoMed Inc., Plano TX	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.; Other Names: "TAP1" Oral Appliance; washout; "SomnoDent Flex"; 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.; Other Names: "SomnoDent Flex"; washout; "TAP1"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Texas A&M University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2017
• Primary Completion (Actual): March 20, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: sleep apnea; sleep quality; oral appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2017-0390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes