Phase
Condition
Dysrhythmia
Cardiac Disease
Chest Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pre-qualified for ablation AF intervention
AF > 1 documented episode in a 24-hour electrocardiogram (ECG) Holter examination orimplanted AF monitor in the previous 1 month prior to study enrollment; [AF episodedefined 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 OAuse
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
Exclusion Criteria:
Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)] or cardiopulmonary disease [heart failure, Chronic obstructive pulmonarydisease (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 morphologicalairway abnormalities
Pre-existing difficulty swallowing; throat or neck related health issues; endocrinedysfunction; 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 heartfailure 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
Study Design
Study Description
Connect with a study center
Texas A&M College of Dentistry, Health Science Center
Dallas, Texas 75246
United StatesActive - Recruiting
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