Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Gregory Marcus, MD, MAS (ucsf)
Headshot of Gregory Marcus
Gregory Marcus

Description

Summary

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.

Details

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. Our primary analyses will employ intention-to-treat principles, examining randomization assignment as the primary predictor.

Keywords

Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC), Atrial Fibrillation (AF), Premature Atrial Contraction, Sleep Apnea, Hypoglossal Nerve Stimulation Device, Atrial Fibrillation, Upper Airway Stimulation, Premature Ventricular Contraction, Ventricular Premature Complexes, Atrial Premature Complexes, Sleep Apnea Syndromes, HGNS Use Randomized Instructions

Eligibility

You can join if…

Open to people ages 21 years and up

  • Are age 21 years or older
  • Have a HGNS device implanted for obstructive sleep apnea and followed up at UCSF Health
  • Are willing to abstain from using the upper airway stimulation device for no more than two consecutive days as instructed over the 14-day trial period
  • Able and willing to provide written informed consent

You CAN'T join if...

  • Currently pregnant or trying to get pregnant
  • Are currently taking class 1 or 3 anti-arrhythmic medications
  • Have a history of permanent AF or expected to have continuous AF throughout the study period
  • Have congenital heart disease
  • Ventricular pacing >40%
  • Are unable to read or sign to provide informed consent

Location

  • UCSF Medical Center at Parnassus accepting new patients
    San Francisco 5391959 California 5332921 94143 United States

Lead Scientist at University of California Health

  • Gregory Marcus, MD, MAS (ucsf)
    Dr. Gregory Marcus is a specialist in the treatment of arrhythmias, including mapping and catheter ablation for atrial fibrillation, supraventricular tachycardias and ventricular arrhythmias. He is also an expert in pacemaker, biventricular device and defibrillator implantation. RESEARCH Dr. Marcus is Associate Chief of Cardiology for Research at UCSF Health. He is also an Ass…

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07220525
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated