Atrial Fibrillation Clinical Trial
Official title:
Oropharynx-Brainstem-Heart Connection: A Controlled Clinical Trial to Assess Atrial Fibrillation Attenuation in Patients Treated With Oral Appliance Therapy
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas A&M College of Dentistry, Health Science Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas A&M University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | MyTAP advancement change from T1 to T2 | OA advancement in mm | 1 month | |
Secondary | Heart rate variability analysis after 1 month compared with baseline (T0) | HRV in ms | 1 month | |
Secondary | Apnea hypopnea index after 1 month (T2) compared with T0-1 | Number of apneas and hypopneas per hour of recording | 1 month | |
Secondary | Oxygen desaturation index after 1 month (T2) compared with T0-1 | Percent oxygen desaturation | 1 month | |
Secondary | Epworth Sleepiness Scale (ESS); Score =10 is sleepy, = 18 is very sleepy. | Change in subjective ESS score pre-OA intervention vs. after 4-weeks of OA use | 1 month |
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