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NCT Number: NCT07220525

Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HGNS Use Randomized Instructions

Device

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.

Primary outcomes

  1. Ectopic beats

    Time frame: 24-hour time period

    Daily number of ectopic beats as recorded with the adhesive heart monitor

Secondary outcomes

  1. Premature Atrial Contractions (PACs)

    Time frame: 24-hour time period

    Daily number of PACs as recorded with the adhesive heart monitor

  2. Premature Ventricular Contractions (PVCs)

    Time frame: 24-hour time period

    Daily number of PVCs as recorded with the adhesive heart monitor

  3. Atrial Fibrillation (AF)

    Time frame: 24-hour time period

    Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor

Study contacts

Contact information is provided by the study sponsor or research team.

Bella Peña, BA

CONTACT

[email protected]

415-502-3053

Hannah Oo, BS

CONTACT

[email protected]

415-476-4999

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: DISCRETE AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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