Effect of Oral Appliance Therapy on Atrial Fibrillation

NCT03835429 | Terminated FDA Device

• 1 other identifier: IRB2018-0954
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is expected to determine the efficacy of using the midline traction designed MyTAP plus mouth shield (MyTAP + MS) oral appliance combination in decreasing the number of Atrial Fibrillation events. The MS is a patient comfort accessory to the MyTAP.

Conditions

Atrial Fibrillation

Keywords

oral appliance; atrial fibrillation; sleep apnea; mouth shield; snoring

Outcome Measures

Primary Outcomes (2)

• AF incidence

  Measured (%) incidence of paroxysmal AF episodes \>10 seconds in duration, 1-month after starting OA (T1) therapy compared with 1-month prior to using OA.

  1 month

• Periodontal conditions

  Periodontal conditions (defined according to classification developed by Centers for Disease Control and Prevention and the American Academy of Periodontology (CDC-AAP)) 24 assessment at (T0) before MyTAP + MS initiation and after 1-month (T1).

  1 month

Secondary Outcomes (5)

• MyTAP advancement change from T1 to T2

  1 month

• Heart rate variability analysis after 1 month compared with baseline (T0)

  1 month

• Apnea hypopnea index after 1 month (T2) compared with T0-1

  1 month

• Oxygen desaturation index after 1 month (T2) compared with T0-1

  1 month

• Epworth Sleepiness Scale (ESS); Score ≥10 is sleepy, ≥ 18 is very sleepy.

  1 month

Study Arms (1)

MyTAP oral appliance plus mouth shield

EXPERIMENTAL

MyTAP plus mouth shield

Device: MyTAP oral appliance plus mouth shield

Interventions

MyTAP oral appliance plus mouth shield DEVICE

The midline traction oral appliance (MyTAP, Airway Management Inc.(AMI), Dallas Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared.

Also known as: Oral appliance midline traction

MyTAP oral appliance plus mouth shield

Eligibility Criteria

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

You may qualify if:

• Pre-qualified for ablation AF intervention
• AF \> 1 documented episode in a 24-hour electrocardiogram (ECG) Holter examination or implanted AF monitor in the previous 1 month prior to study enrollment; \[AF episode defined as at least 12 hours duration\]
• At least 8 teeth per arch to support OA device
• Use of continuous positive air pressure (CPAP)therapy and willingness to switch to OA use
• Willing and able to provide verbal and written informed consent
• Ability to understand how to apply and utilize the sleep recorder and the OA device

You may not qualify if:

• Patients with implantable cardiac rhythm device \[pacemakers or internal cardiac device (ICDs)\] or cardiopulmonary disease \[heart failure, Chronic obstructive pulmonary disease (COPD), ventricular dysrhythmia\]
• Unable or unwilling to complete the study demands and schedule
• Comorbidities of other sleep disorders other than OSA
• No active temporomandibular joint disorders (TMD) or jaw muscle pain, or morphological airway abnormalities
• Pre-existing difficulty swallowing; throat or neck related health issues; endocrine dysfunction; severe psychiatric and neurological disorders; intellectually disabled; handicaps limiting sleep position
• Previous OA therapy or restrictions in jaw opening
• Prior ablation of AF, myocardial infarction (MI), stroke or decompensation of heart failure within the last six months, untreated overt hyper- or hypothyroidism
• Commencement of new anti-arrhythmic drug since last monitor check
• Pharmacological dependency
• Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol intake
• Mallampati score \> III
• Palatine tonsils - grade \> 2
• History of Uvulopalatopharyngoplasty (UPPP) surgery

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M School of Dentistry, Health Science Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Emet Schneiderman, PhD

  TAMHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Biomedical Sciences

Model Details: Non-randomized clinical controlled trial design

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 8, 2019
• Study Start: January 15, 2019
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)