Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation

NCT07220525 | Recruiting FDA Device

• 1 other identifier: 25-43785
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Atrial Fibrillation (AF); Premature Atrial Contraction; Obstructive Sleep Apnea; Premature Ventricular Contraction (PVC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Ectopic beats

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

  24-hour time period

Secondary Outcomes (3)

• Premature Atrial Contractions (PACs)

  24-hour time period

• Premature Ventricular Contractions (PVCs)

  24-hour time period

• Atrial Fibrillation (AF)

  24-hour time period

Study Arms (2)

HGNS 'Off' Case-Crossover Arm

EXPERIMENTAL

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.

Device: HGNS Use Randomized Instructions

HGNS 'On' Case-Crossover Arm

EXPERIMENTAL

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.

Device: HGNS Use Randomized Instructions

Interventions

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.

HGNS 'Off' Case-Crossover Arm; HGNS 'On' Case-Crossover Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Ventricular Premature Complexes; Atrial Fibrillation; Atrial Premature Complexes; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Oo, BS

CONTACT

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

Bella Peña, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)