The Effect of Using Transcranial Direct Current Stimulation in Improving Quality of Sleep in Athletes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Daytime sleepiness (using Epworth Sleepiness Scale)
研究概览
简要总结
Sleep disturbances in athletes was found prevalent and affect their cognitive and physical abilities and increase the risk of injury. Moreover, studies showed also that a better sleep produces a better athletic performance. Therefore, it is important to find out management strategies that improve quality of sleep in this population.
Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that modulates cortical activity. tDCS has been conducted to improve wide range of neurological impairments including sleep. tDCS was used in improving the quality of sleep in older adults and in athletes. Both studies found improvement in some sleep indices.
详细描述
Research ethics:
- Institutional Review Board approval was sought out from University of Jordan before the beginning of the study.
- Informed consent will be obtained from athletes guaranteed their approval to participate in the study.
- To insure the privacy of participants, every athlete will be assigned a study identification number.
- All results will be stored in a locked cabinet/computer.
Study design and participants:
This is double -blinded randomized placebo-controlled parallel trial. The study will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological treatment (Boutron et al., 2008). Data will be collected prospectively from athletes from different sports in Jordan.
Sample Size calculation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Athletes who are 12 years of age and older.
- •Athletes who have a complaint of sleep impairment determined by >5 total score on Pittsburg Sleep Quality Index (PSQI).
排除标准
- •Athletes who is using sleep medications or treatment.
- •Athletes who have more than 1 concussion in the past year.
- •Wearing a pacemaker.
- •Pregnant athletes.
- •Athletes who have repetitive migraine
- •Athletes who are wearing a metal implant.
- •Athletes who have epilepsy.
结局指标
主要结局
Daytime sleepiness (using Epworth Sleepiness Scale)
时间窗: After 4 weeks.
The effect of the intervention on daytime sleepiness. It consists of 8 items where the subject uses a 4-point Likert scale to rate how likely they would be to fall asleep in 8 different scenarios of daily activities. The total score ranges between 0-24 with a higher score indicates worse daytime sleepiness.
Severity of sleep impairment (using Insomnia Severity Index)
时间窗: After 4 weeks.
The effect of the intervention on insomnia severity. The total score ranges between 0 and 28 with a higher score indicates more sever insomnia (worse).
Quality of Sleep (using Actigraph activity monitor)
时间窗: After 3 weeks.
The effect of the intervention on quality of sleep. The wGT3X-BT is ActiGraph's flagship activity monitor, used to capture and record continuous, high resolution physical activity and sleep/wake information.
The Quality of sleep (Using Pittsburgh Sleep Quality Index)
时间窗: After 2 Months from baseline.
The effect of the intervention on the Quality of sleep. The total score ranges from 0 to 21 with a higher score indicates poor quality of sleep (worse). A cut-off score of \>5 indicates poor sleep quality.
次要结局
- The Quality of Life (using Medical Outcomes Study Short Form 12)(After 4 weeks.)
- The severity of anxiety, depression, and stress (using Depression Anxiety Stress Scale-21)(After 4 weeks.)
研究者
Alia A. Alghwiri
Professor of Physiotherapy
University of Jordan