Effects of Sleep Body Temperature on Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
This will be a crossover controlled trial designed to recruit 40 participants, who will be divided into two groups of 20 subjects each. The participants will be randomly assigned to either Group A or Group B. Group A will receive the sleep electric blanket intervention for a period of 7 days, while Group B will serve as the control group without any additional intervention. After the intervention period, there will be a washout period of 7 days to ensure that any effects of the intervention have subsided before the crossover.
Following the washout period, the groups will switch roles: Group B will then receive the sleep electric blanket intervention, and Group A will become the control group. This second phase will also last for 7 days, preceded and followed by the same assessment procedures as the initial phase. This design will allow for a comparison of the intervention's effects against a control period within the same group of participants, enhancing the study's internal validity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18-30 years, inclusive of both male and female genders.
排除标准
- •Individuals suffering from serious diseases such as heart, liver, kidney, brain, hematopoietic, immune, thyroid, malignant tumors, etc.;
- •Those with familial hereditary hypertension (both parents are hypertensive) or those diagnosed with hypertension;
- •Individuals with cognitive or mental impairments that prevent the completion of the questionnaire;
- •Persons with physical disabilities that hinder normal walking;
- •Persons who have experienced a weight change of >3.0 kg within 1 month or >10 kg within 6 months prior to screening (as per the study in Nutrients. 2020 Oct 21;12(10):3221);
- •Individuals required to take antibiotics from one week before the trial starts until its conclusion;
- •Those with habitual diarrhea or who have experienced diarrhea from one week before the trial starts until its end;
- •Subjects who have participated in other ambient temperature-related trials within the last 6 months;
- •Individuals with extreme sleep schedules (i.e., not falling asleep between 21:00 and 2:00 a.m. the following morning, or waking up before 5:00 a.m.);
- •Those with sleep latency (the time it takes to fall asleep after going to bed) greater than one hour;
- •Pittsburgh Sleep Quality Index (PSQI) scores greater than 16;
- •Participants who do not sign the informed consent form or are deemed unsuitable by the investigator for any other reason.
结局指标
主要结局
Blood pressure
时间窗: 1month
Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.
次要结局
未报告次要终点
研究者
Fangfang Zeng
Associate Professor
Jinan University Guangzhou