Clinical trial NCT06648109: Effects of Sleep Body Temperature on Body Composition
Official title: Effects of Sleep Body Temperature on Body Composition
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Pressure Check (Hypertension Screening)
Heart Rate
Aldosterone Disorder
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a crossover controlled trial to recruit 40 people, divided into two groups of 20 subjects each using randomised grouping and named Group A and Group B. Group A will receive the sleep electric blanket intervention for a period of 7 days and Group B will serve as the control group without additional intervention, followed by a washout period of 7 days. A 1-stage baseline as well as a 3-stage follow-up including questionnaires, physical and grip strength measurements, blood index tests, and dormitory environment measurements were required.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Blood pressure
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jinan University Guangzhou
state: Select a State
Study officials:
References: