Recruiting

Sleep Disruption

Sponsor:

UCLA

Code:

NCT07220525

Conditions

Obstructive Sleep Apnea

Premature Ventricular Contraction (PVC)

Atrial Fibrillation (AF)

Premature Atrial Contraction

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

HGNS Use Randomized Instructions

Study Details

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.

Conditions

Obstructive Sleep Apnea

Premature Ventricular Contraction (PVC)

Atrial Fibrillation (AF)

Premature Atrial Contraction

Study ID

NCT07220525

Start date

Dec 15, 2025

Status verified date

Jan, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HGNS 'Off' Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to turn off/not use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row.

experimental: HGNS 'On' Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to turn on/use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Interventions

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.

Primary outcome measure

  • Ectopic beats [ Time Frame: 24-hour time period ]

Central Contacts and Locations

Central contacts

Hannah Oo, BS

415-476-4999hannah.oo@ucsf.edu

Bella Peña, BA

415-502-3053bella.pena@ucsf.edu

Locations

UCSF Medical Center at Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Gregory Marcus, MD, MAS

415-476-5706greg.marcus@ucsf.edu

Principal Investigator:

Gregory Marcus, MD, MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Keywords

  • Sleep Apnea
  • Hypoglossal Nerve Stimulation Device
  • Atrial Fibrillation
  • Upper Airway Stimulation
  • Premature Atrial Contraction
  • Premature Ventricular Contraction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-23.