Disrupted sleep and irregular heartbeats in people with hypoglossal nerve stimulators
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
This study will test whether turning a hypoglossal nerve stimulation (HGNS) device off for a night increases the chance of irregular heartbeats or short atrial fibrillation episodes in adults with obstructive sleep apnea who already have an HGNS implant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07220525 on ClinicalTrials.gov |
What this trial studies
This is a randomized case-crossover trial enrolling 100 adults with implanted HGNS devices for obstructive sleep apnea. Participants are randomized to alternating "off-on" or "on-off" device-night sequences over 14 days, with no more than two consecutive nights of the same setting. All participants wear an ambulatory ECG recorder that automatically logs daily counts of ectopic beats, PACs, PVCs, and AF episodes ≥30 seconds. The primary outcome is the daily number of ectopic beats, analyzed by intention-to-treat comparing randomized device-on versus device-off nights.
Who should consider this trial
Good fit: Ideal candidates are adults (≥21 years) with an implanted HGNS device for OSA who are followed at UCSF, do not have permanent AF, are not taking class 1 or 3 antiarrhythmic drugs, and can follow the on/off device instructions for 14 days.
Not a fit: Patients with permanent or continuous AF, those taking class 1 or 3 antiarrhythmic medications, pregnant people, those with congenital heart disease, or those unable to comply with device instructions or consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the trial could clarify whether a single night of sleep disruption directly raises short-term arrhythmia risk and help guide device use and arrhythmia prevention in OSA patients with HGNS implants.
How similar studies have performed: Prior research links chronic sleep disruption to higher long-term AF risk, but this randomized nightly on/off HGNS crossover design to study acute effects on ectopy and short AF episodes is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California
- UCSF Medical Center at Parnassus — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Gregory Marcus, MD, MAS — University of California, San Francisco
- Study coordinator: Hannah Oo, BS
- Email: hannah.oo@ucsf.edu
- Phone: 415-476-4999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.