Trials / Recruiting
RecruitingNCT07220525
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Obstructive Sleep Apnea
- Premature Ventricular Contraction (PVC)
- Atrial Fibrillation (AF)
- Premature Atrial Contraction
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-12-15
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2025-10-24
- Last updated
- 2026-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07220525. Inclusion in this directory is not an endorsement.