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.
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 ablation is associated with 25% increased risk in patients with obstructive
sleep apnea (OSA). One hypothesis suggests that the repeated hypoxic episodes time-linked to
OSA and central sleep apnea may act as chemo-reflex triggers that enhances brainstem
sympathetic activity in conjunction with responses to OSA-event hypoxia. This hypothesis is
believed to induce tachycardia and cardiovascular stress. In an animal model, episodes of
hypoxia were shown to induce pulmonary vein burst firing and reduction of the negative
tracheal pressure promptly restored normal sinus rhythm. The Trigemino-cardiac reflex
hypothesis implicates chemo- and mechanoreceptors in the oronasal cavity that provides
signaling to the reticular formation via the mesencephalic nucleus of the trigeminal nerve
and serves to control breathing, cardiac function, blood pH (acidity), amongst other body
functions.
The sympathetic system in patients with OSA syndrome is considered to be chronically
hypersensitized. A hyperarousal state suggests AF patients with OSA would tend to have AF
occur more frequently in conjunction with apnea hypopnea events. An increase in autonomic
sympathetic cardiac dominance with a withdrawal of cardiac parasympathetic control could
easily be driven by mechanoreceptors in the oropharynx upon airway narrowing and present as
decreased heart rate variability. Considering that the upper airway is often the site of
greatest airflow restriction (i.e. snoring), a potential sudden rise in autonomic sympathetic
nerve activity in sensory afferent fibers from the oropharynx should be the first to
communicate the airflow reduction to brainstem. This theory is supported by the
investigators' preliminary data and those in other reports. Oral appliance (OA) therapy that
prevents snoring in conjunction with a mouth shield should simultaneously facilitate an open
airway and prevent mouth breathing. The combination effect is expected to decrease vagus
nerve motor efferent activity to the esophagus, facilitate nasal breathing, reduce
sympathetic tone, promote stable sleep and increase HRV(heart rate variability). In patients
with AF, the MyTAP + MS intervention is likely to also facilitate putatively effective
medical therapies, reduce noxious AF triggers, and maintain normal oral bacterial flora
levels and cardiac functioning.
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