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

NCT ID: NCT03219034

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-10
• Study Completion Date: 2019-03-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

oral appliance - A ; washout; oral appliance B

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

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

Group Type: EXPERIMENTAL

oral appliance - A ; washout; oral appliance B

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

"TAP1" Oral Appliance; washout; "SomnoDent Flex"; "SomnoDent Flex"; washout; "TAP1"

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Emet D. Schneiderman, PhD

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emet Schneiderman, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University College of Dentistry

Locations

Texas A&M University College of Dentistry

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32942939 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017-0390

Identifier Type: -

Identifier Source: org_study_id