Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Atrial arrhythmias
研究概览
简要总结
The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older.
- •Healthy subjects without known cardiovascular disease and thyroid disease.
- •Subjects who are on no medications (except oral contraceptive pill).
- •Nonsmokers.
- •No prior history of caffeine sensitivity or allergy.
排除标准
- •Subjects with known cardiovascular or thyroid disease.
- •Subjects currently taking medications other than oral contraceptive pill.
- •Prior history of caffeine sensitivity or allergy.
- •Pregnancy.
- •Subjects who regularly consume energy drinks.
- •Subjects who typically go to sleep after midnight.
- •Subjects who traveled across 2 time zones in the last 7 days.
- •Shift workers.
- •Subjects who have or are suspected to have sleep apnea.
- •Subjects who have a body mass index > 35kg/m^2.
结局指标
主要结局
Atrial arrhythmias
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic atrial beats
Changes in sleep continuity
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of wakefulness after sleep initiation
Changes in sleep architecture
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
Time spent in each stage of sleep
QT segment
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
QT duration
Changes in sleep efficiency
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
Time asleep / time in bed
Ventricular arrhythmias
时间窗: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic ventricular beats
次要结局
- Sympathetic activation quantified by changes in plasma dopamine(Baseline and AM of day 2)
- Sympathetic activation quantified by changes in plasma epinephrine(Baseline and AM of day 2)
- Sympathetic activation quantified by urine norepinephrine(Approximately 24 hours)
- Sympathetic activation quantified by urine epinephrine(Approximately 24 hours)
- Sympathetic activation quantified by changes in plasma norepinephrine(Baseline and AM of day 2)
- Sympathetic activation quantified by urine dopamine(Approximately 24 hours)
研究者
Anna Svatikova
Principal Investigator
Mayo Clinic