A Randomized, Double-blind, Placebo-controlled, Parallel Clinical Study to Investigate the Sleep Quality Enhancing Effect and Safety of Lactobacillus-fermented GABA in Subjects With Mild, Transient Sleep Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change of wake after sleep onset of polysomnography
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of dietary supplement GABA in subjects with mild, transient sleep disorder.
详细描述
The subjects will take GABA or placebo capsule once daily before sleep for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects older than 19 years old
- •Who is experiencing mild, transient sleep disturbance (pittsburgh sleep quality index ≥ 5, Insomnia Severity Index ≥ 8)
- •Who voluntarily agreed to participate in the study and signed an informed consent form.
排除标准
- •Who is suffering from severe sleep disorder including sleep disorders due to psychological or neurologic causes.
- •Who has used sleeping pills or sleep related dietary supplements within 4 weeks before study participation
- •Who is suffering from obstructive sleep apnea.
- •Who has used or is expected to inevitably use prohibited concomitant medications during the study.
- •Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives.
- •Who has dosed other study medications within 30 days before screening.
- •Who is determined ineligible for study participation by investigators for any other reasons.
结局指标
主要结局
Change of wake after sleep onset of polysomnography
时间窗: Baseline, Week 2
wake after sleep onset(mintues)
Change of total sleep time of polysomnography
时间窗: Baseline, Week 2
total sleep time(minutes)
Change of sleep efficiency of polysomnography
时间窗: Baseline, Week 2
sleep efficiency(percent)
Change of sleep latency of polysomnography
时间窗: Baseline, Week 2
sleep latency(minutes)
Change of NonREM stage3 of polysomnography
时间窗: Baseline, Week 2
NonREM stage3(mintues)
Change of total wake time of polysomnography
时间窗: Baseline, Week 2
total wake time(mintues)
次要结局
- Change of Insomnia Severity Index(Baseline, Week 2)
- Change of Fatigue Severity Scale(Baseline, Week 2)
- Change of Pittsburgh Sleep Quality Index(Baseline, Week 2)
- Change of Epworth sleepiness scale(Baseline, Week 2)