NCT05828680进行中（未招募）不适用
Circadian Rhythm Disruption in the Hospital Intensive Care Environment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Sleep depth
研究概览
简要总结
Abrupt changes to one's lifestyle disrupt biorhythms. Acute effects are well known from jet lag where transmeridian travel leads to insomnia, fatigue, irritability, gastrointestinal symptoms and other complaints. Several studies in the hospital environment reported dampened and misaligned biorhythms, suggesting that the inpatient experience is replete with circadian disruptors. However, comprehensive assessments of how circadian clocks are affected in intensive care and how this predicts post-operative recovery and risk are largely missing.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adults scheduled for cardiac surgery;
- •≥18 years of age;
- •Capable of giving informed consent;
- •Own a smartphone (Apple devices only).
排除标准
- •Taking sleep aids (antihistamines, melatonin, etc.)
- •History of alcohol abuse (more than 2 drinks a day with last drink within the past 3 days)
- •History of substance abuse at risk of postoperative withdrawal;
- •Active diagnosis of alcohol or substance abuse;
- •Recent travel across more than two (2) time zones (within the past month);
- •Planned travel across more than two (2) time zones during the planned study activities;
- •Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening;
- •Subjects without access to WiFi in their or close to home or at work;
- •Patients with hearing aids;
- •Heart transplant patients;
- •Patients in isolation.
研究组 & 干预措施
Elective cardiac surgery
干预措施: Observation (Other)
结局指标
主要结局
Sleep depth
时间窗: Up to 48 hours
Variance in sleep depth assessed as percent REM sleep of total sleep time (TST)
次要结局
- Purpose of recorded patient visits(24 hours)
- Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)(Up to 24 hours)
- Odds Ratio Product-based sleep depth(Up to 48 hours)
- Number of recorded patient visits(24 hours)
研究者
研究点 (1)
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