Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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
Locations
United States
California
UCSF Medical Center at Parnassus
RECRUITING
San Francisco
Contact Information
Primary
Hannah Oo, BS
hannah.oo@ucsf.edu
415-476-4999
Backup
Bella Peña, BA
bella.pena@ucsf.edu
415-502-3053
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 100
Treatments
Experimental: HGNS 'Off' Case-Crossover Arm
On a given day of the 14-day study period, participants may be randomly assigned to turn off/not use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row.
Experimental: HGNS 'On' Case-Crossover Arm
On a given day of the 14-day study period, participants may be randomly assigned to turn on/use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco