The Study of the Relationship Between Sleep Pattern, Attention Performance, and Heart Rate Variability Among Night Workers.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Pittsburgh sleep quality index (PSQI）
研究概览
简要总结
The study of the relationship between sleep pattern, attention performance, and heart rate variability among night workers.
详细描述
Background: Previous study found that sleeping in the morning or evening pattern might be associated with performance among night workers. Both their sleep quality and circadian rhythm are critical for the performance at night. The study aims to identify the association between sleep pattern and performance among night workers. The effectiveness of interventions either supplement with melatonin for those who not meeting the DSM-5 criteria of Circadian Rhythm Sleep-Wake Disorders, CRSWD and prescription of melatonin agonist ramelteon for those who meet the DSM-5 criteria of CRSWD will be evaluated.
Methods:
The investigators will prescribe melatonin agonist ramelteon for 80 subjects those who agree to participate and meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders. They will receive the assessments including questionnaires and performance measurements before and after prescription with melatonin agonist 8 mg for 2 weeks to investigate the effectiveness of melatonin agonist.
Anticipated outcome: The study will help the understanding the association of sleep pattern and performance among night workers. The effectiveness of either supplement with melatonin and prescription of melatonin agonist will be evaluated. The findings of our study might be implicated in the plans of intervention for better performance for night warriors.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The individuals aged 20-55 who are night workers whose working hours more than 4 hours duration between 22:00 to 06:
- •Meet the DSM-5 diagnostic criteria of this Circadian Rhythm Sleep Wake Disorders.
排除标准
- •The individuals could not understand the online questionnaires and is not willing to fill out questionnaires.
- •The individual is not willing to have supplement with melatonin.
- •Not willing to have prescription with melatonin agonist ramelteon.
研究组 & 干预措施
Ramelteon
comparison of anxiety/depression, insomnia symptoms severity between before and after treatment with 8mg Ramelteon per day for two weeks among shift time workers.
干预措施: Ramelteon (Drug)
结局指标
主要结局
Pittsburgh sleep quality index (PSQI）
时间窗: 2 weeks
The investigators will measure if the severity improve after using Somn Well XR and Rozerem by the PSQI scale. The cutoff score for the cutoff score for the Pittsburgh Sleep Quality Index (PSQI) questionnaire is 5. Higher scores on both questionnaires indicate a greater severity of sleep issues.
次要结局
- Beck Depression Inventory (BDI)(2 weeks)
研究者
Chin-Bin Yeh, MD, PhD
Principal Investigator, Professor
Tri-Service General Hospital