Disrupted sleep and irregular heartbeats in people with hypoglossal nerve stimulators
Official title: Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Run by University of California, San Francisco · NCT07220525 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07220525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.