NCT05396729招募中不适用
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep Quality in Healthy Volunteers on the Plateau
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- total sleep time in 5 days
研究概览
简要总结
Sleep disorder is common in people going to plateau. Acupuncture and related techniques could be used for treatment of sleep disorder. In this trial the effect of transcutaneous electrical acupoint stimulation on sleep disorder in people going to plateau will be investigated.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The stimulator is put in an opaque box
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 40 years
- •first time to the plateau (altitude ≥3000 meters)
排除标准
- •those who live in area with altitude ≥2000 meters, or travel to plateau in the last half year
- •history of insomnia
- •patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
- •difficulty in verbal communication
- •history of taking medicine to improve sleep during the last 3 months
- •regular daily intake of large dose of tea or coffee (>400 mg of caffeine)
- •suspected or existed abuse of drug or alcohol
- •disease that influence sleep such as chronic pain
结局指标
主要结局
total sleep time in 5 days
时间窗: from arrived at plateau to 5 days after arrival, in a total of 5 days
次要结局
- sleep latency on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- sleep efficiency on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- number of awake on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- Pittsburgh sleep quality index on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- Score of Cognition Assessment on the third day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- lowest saturation of pulse oxygenation on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- highest systolic blood pressure on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
- highest heart rate on the fifth day(from arrived at plateau to 5 days after arrival, in a total of 5 days)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China
研究点 (1)
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