Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07220525
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 15, 2025
Status verified
Jan 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at ParnassusSan FranciscoCalifornia94143
Gregory Marcus, MD, MAS
[email protected]
415-476-5706
Gregory Marcus, MD, MAS (PRINCIPAL_INVESTIGATOR)

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By research site
UCSF Medical Center at Parnassus· San Francisco, CA

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