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

NCT03219034 | Completed Results FDA Device

• 1 other identifier: 2017-0390
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

oral appliance; sleep quality; sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Stable Sleep Percent

  4 weeks

Study Arms (2)

Oral appliance - A

EXPERIMENTAL

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; Device: oral appliance - B; washout; oral appliance A

Oral appliance - B

EXPERIMENTAL

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; Device: oral appliance - B; washout; oral appliance A

Interventions

oral appliance - A ; washout; oral appliance B 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.

Also known as: "TAP1" Oral Appliance; washout; "SomnoDent Flex"

Oral appliance - A; Oral appliance - B

oral appliance - B; washout; oral appliance A 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.

Also known as: "SomnoDent Flex"; washout; "TAP1"

Oral appliance - A; Oral appliance - B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University College of Dentistry

Dallas, Texas, 75246, United States

Location

Related 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.

  PMID: 32942939 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Dr. Emet Schneiderman
• Organization: Texas A&M University College of Dentistry

eschneiderman@tamu.edu

2148288377

Study Officials

• Emet Schneiderman, PhD

  Texas A&M University College of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Study Start: October 10, 2017
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)