Status:
TERMINATED
Effect of Oral Appliance Therapy on Atrial Fibrillation
Lead Sponsor:
Texas A&M University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 Fibrill...
Detailed Description
Atrial fibrillation (AF) is highly prevalent in the U.S. and possesses a greater risk in patients with sleep disordered breathing (SDB) versus patients without SDB. AF recurrence after catheter ablati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03835429
Start Date
January 15 2019
End Date
January 3 2025
Last Update
September 30 2025
Active Locations (1)
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1
Texas A&M School of Dentistry, Health Science Center
Dallas, Texas, United States, 75246