Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HGNS Use Randomized Instructions.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC), Atrial Fibrillation (AF), Premature Atrial Contraction. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device 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 measures
- Ectopic beats [Time frame: 24-hour time period]
Secondary outcome measures (3)
- Premature Atrial Contractions (PACs) [Time frame: 24-hour time period]
- Premature Ventricular Contractions (PVCs) [Time frame: 24-hour time period]
- Atrial Fibrillation (AF) [Time frame: 24-hour time period]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UCSF Medical Center at Parnassus — San Francisco
Identifiers
NCT: NCT07220525 · 25-43785