NCT05958329已完成不适用
Remote Short Sessions of Heart Rate Variability Biofeedback
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Heart Rate Variability
研究概览
简要总结
Remote 5 minute sessions of heart rate variability (HRV) biofeedback will be employed by participants for 5 weeks. Subjects will be followed for a total of 17 weeks. Surveys assessing psychological well being will be completed during the study period. Wearable devices will be worn to monitor HRV response during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were recruited from The Mount Sinai Hospital, Morningside Hospital, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai Queens, New York Eye and Ear Infirmary, and Mount Sinai Brooklyn.
- •Eligible participants were 18 years of age or greater.
- •Had an iPhone series 5 or greater.
- •Had or were willing to wear an Apple Watch 4 or greater.
- •Potential participants were excluded if they had an underlying chronic disease or used a medication that is known to impact autonomic nervous system function.
排除标准
- •Underlying chronic diseases including but not limited to:
- •rheumatoid arthritis
- •systemic lupus erythematosus
- •inflammatory bowel disease
- •Use of medications that impact heart rate variability including but not limited to:
- •beta-blockers (ie. atenolol, carvedilol, metoprolol, Coreg, Tenormin, Normodyne, Trandate)
- •calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem)
- •regularly used benzodiazepines
研究组 & 干预措施
HRV Biofeedback
Experimental
5 minute daily sessions of HRV biofeedback
干预措施: HRV Biofeedback (Behavioral)
结局指标
主要结局
Heart Rate Variability
时间窗: Up to Week 7
Heart rate variability measured in milliseconds (ms) at 7 weeks compared to baseline. Higher rates indicate increased parasympathetic nervous system activity.
次要结局
- Connor-Davidson Resilience Scale (CD-RISC(Up to Week 17)
研究者
Robert Hirten
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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