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 range18 Years
SexALL
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 dā¦