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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

oral appliance - A ; washout; oral appliance B

oral appliance - B; washout; oral appliance A

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring oral appliance, sleep quality, sleep apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Texas A&M University College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Oral appliance - A

Oral appliance - B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Stable Sleep Percent

Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis

Full Information

NCT ID

NCT03219034

First Posted

July 11, 2017

Last Updated

January 6, 2022

Sponsor

Texas A&M University

1. Study Identification

Unique Protocol Identification Number

NCT03219034

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

October 10, 2017 (Actual)

Primary Completion Date

March 20, 2019 (Actual)

Study Completion Date

March 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Texas A&M University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

oral appliance, sleep quality, sleep apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral appliance - A

Arm Type

Experimental

Arm Description

Arm Title

Oral appliance - B

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

oral appliance - A ; washout; oral appliance B

Other Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

oral appliance - B; washout; oral appliance A

Other Intervention Name(s)

"SomnoDent Flex"; washout; "TAP1"

Intervention Description

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.

Primary Outcome Measure Information:

Title

Respiratory Event Index (REI) at T2

Description

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.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Stable Sleep Percent

Description

Percent of stable sleep during the recording, specifically the percentage of high frequency coupling (HFC%) from cardiopulmonary coupling (CPC) Analysis

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emet Schneiderman, PhD

Organizational Affiliation

Texas A&M University College of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Texas A&M University College of Dentistry

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32942939

Citation

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.

Results Reference

result

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

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