Effects of Sleep Body Temperature on Body Composition

Обзор

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.

Вмешательства

• Устройство Electric Blanket
  Participants were randomized to groups A and B. When the subject\'s group cohort went through the intervention phase (instead of the control phase), they received a 7-day, 8-hour intervention with an electric blanket +5±1°C above room temperature.

Первичные конечные точки

• Blood pressure [Срок оценки: 1month]

Критерии участия

Критерии включения

\- Participants aged 18-30 years, inclusive of both male and female genders.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Jinan University Guangzhou — Гуанчжоу

Идентификаторы

NCT: NCT06648109 · JNUKY-2023-0126

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗