Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Recruiting · NCT07220525 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
HGNS Use Randomized Instructions
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- UCSF Medical Center at Parnassus - San Francisco, California, United States