Stress-, Anxiety-, and Cellphone Use-induced Sleep Deficits and Psychological Conditions During the Pandemic and a Potential Complementary Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Effect of DHM on sleep duration
研究概览
简要总结
The COVID-19 pandemic and social isolation order induced stress/anxiety as well as cellphone dependence. As a result, sleep disruption and mental distress became major health concerns. Gamma-aminobutyric acid type-A receptor (GABAAR) is one of the key players in modulating sleep. Dihydromyricetin (DHM), an herbal compound, plays a role in GABAAR modulation and mitigating anxiety. The investigators' partner in China obtained 288 participants who completed the online survey to gain insight into how stress/anxiety and time spent on cellphones affected sleep and mood. The participants were then enrolled in a randomized placebo-controlled double-blind study to assess the effects of DHM on sleep and improvement on stress/anxiety and cellphone using time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects were recruited in Chengdu and Beijing (city) in China,
- •Able and willing to sign informed consent,
- •Between 18 -60 years old at time of consent,
- •No alcohol, drug, and smoking,
- •Not using sleep medication(s) or other psychiatric medications.
排除标准
- •Pregnant or Breastfeeding women,
- •Currently taking any medications for sleep,
- •Reported naps > 3 times per week
- •History of sleep apnea,
- •Current alcohol, drug, and smoking
结局指标
主要结局
Effect of DHM on sleep duration
时间窗: 20 days
Changes in hours of sleep reported as the difference between self-reported hours of sleep before and after DHM or placebo.
Effect of DHM on stress levels
时间窗: 20 days
Changes in stress levels reported as the difference between self-reported stress levels before and after DHM or placebo. Stress levels were scaled from 0 to 10, with 10 being the highest stress level.
Effect of DHM on cellphone time
时间窗: 20 days
Changes in hours spent on cellphone reported as the difference between self-reported cellphone usage before and after DHM or placebo.
Effect of DHM on feelings after waking up
时间窗: 20 days
Changes in negative feelings after waking up, reported as the difference between the self-reported negative feelings before and after DHM or placebo. In the survey, "feelings after waking up" included negative feelings such as tense, lack of motivation, and irritable/angry. To quantify these feelings, a 'Yes' counted as -1 point, a 'No' counted as 0 points, and a 'Not sure' counted as -0.5 points. The sum of these scores were calculated as the total negative feeling after waking up. Lower score (more negative) indicated worse feelings.
次要结局
未报告次要终点
研究者
Jing Liang
Professor
University of Southern California