RECRUITINGINTERVENTIONAL
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
HGNS Use Randomized Instructions
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.
Locations (1)
UCSF Medical Center at Parnassus
San Francisco, California, United States