Whereas the available evidence mostly supports chronic sleep disruption as a risk factor for incident AF, less is known about the near-term risk of a discrete atrial fibrillation (AF) episode following a night of disrupted or poor-quality sleep. This prospective, randomized, case-crossover study aims to examine the acute effects of sleep disruption on clinically relevant cardiac ectopy pertinent to AF.
One hundred patients aged 21 years or older who have a hypoglossal nerve stimulation (HGNS) device implanted for obstructive sleep apnea, without a history of permanent AF, not on Class 1 or 3 antiarrhythmic medications and willing to participate in the study, will be randomized to "off-on" versus "on-off" periods (where "off" is turning off the HGNS device for one night and "on" is turning on the HGNS device), assuring no more than two consecutive days of either device use or not, over the ensuing 14 days. Participants will be fitted with an automatically recording electrocardiographic monitor. The primary endpoint will be the daily number of cardiac ectopic beats, and secondary endpoints: daily number of PACs, daily number of PVCs, and daily presence versus absence of AF episodes ≥ 30 seconds. Primary analyses will employ intention-to-treat principles, examining randomization assignment as the primary predictor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
In this intervention assignment, participants will be instructed to turn off/not use their HGNS device during that night of sleep. HGNS 'on': In this intervention assignment, participants will be instructed to turn on/use their HGNS device during that night of sleep.
UCSF Medical Center at Parnassus
San Francisco, California, United States
RECRUITINGEctopic beats
Daily number of ectopic beats as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Premature Atrial Contractions (PACs)
Daily number of PACs as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Premature Ventricular Contractions (PVCs)
Daily number of PVCs as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Atrial Fibrillation (AF)
Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor
Time frame: 24-hour time period
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