Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
NCT ID: NCT07220525
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-12-15
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Gregory Marcus, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Medical Center at Parnassus
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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25-43785
Identifier Type: -
Identifier Source: org_study_id
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