UCSF Medical Center at Parnassus
San Francisco, California, 94143, United States
Location status: Recruiting
Location contact
Gregory Marcus, MD, MAS
CONTACT
Gregory Marcus, MD, MAS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07220525
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Location status: Recruiting
Gregory Marcus, MD, MAS
CONTACT
Gregory Marcus, MD, MAS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 24-hour time period
Daily number of ectopic beats as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Daily number of PACs as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Daily number of PVCs as recorded with the adhesive heart monitor
Time frame: 24-hour time period
Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor
Contact information is provided by the study sponsor or research team.
Bella Peña, BA
CONTACT
Hannah Oo, BS
CONTACT
University of California, San Francisco
Other
Acronym: DISCRETE AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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