Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ectopic beats
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: HGNS Use Randomized Instructions (Device)
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.
干预措施: HGNS Use Randomized Instructions (Device)
结局指标
主要结局
Ectopic beats
时间窗: 24-hour time period
Daily number of ectopic beats as recorded with the adhesive heart monitor
次要结局
- Premature Atrial Contractions (PACs)(24-hour time period)
- Premature Ventricular Contractions (PVCs)(24-hour time period)
- Atrial Fibrillation (AF)(24-hour time period)