Atrial Fibrillation (AF), Obstructive Sleep Apnea, Premature Atrial Contraction, Premature Ventricular Contraction (PVC)
Conditions
Keywords
Sleep Apnea, Hypoglossal Nerve Stimulation Device, Atrial Fibrillation, Upper Airway Stimulation, Premature Atrial Contraction, Premature Ventricular Contraction
Brief 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.
Detailed description
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.
Interventions
DEVICEHGNS 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ectopic beats | 24-hour time period | Daily number of ectopic beats as recorded with the adhesive heart monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Premature Atrial Contractions (PACs) | 24-hour time period | Daily number of PACs as recorded with the adhesive heart monitor |
| Premature Ventricular Contractions (PVCs) | 24-hour time period | Daily number of PVCs as recorded with the adhesive heart monitor |
| Atrial Fibrillation (AF) | 24-hour time period | Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor |
Countries
United States
Contacts
CONTACTHannah Oo, BS
CONTACTBella Peña, BA
PRINCIPAL_INVESTIGATORGregory Marcus, MD, MAS
University of California, San Francisco
Outcome results
None listed