Effect of Oral Appliance Therapy on Atrial Fibrillation (NCT03835429) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Oral Appliance Therapy on Atrial Fibrillation
Stopped: Recruitment difficulties.
United States3 participantsStarted 2019-01-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.