Effects of Sleep Body Temperature on Body Composition

Jinan University Guangzhou

Status: Not yet enrolling

Conditions: Aldosterone Disorder; Heart Rate; Blood Pressure Check (Hypertension Screening)

Treatments: Device: Electric Blanket

Study type: Interventional

Funder types: Other

Identifiers

NCT06648109

JNUKY-2023-0126

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Mild-heat group

Experimental group

Description:

Participants will be randomized into groups A and B. When the subject's group cohort undergoes the intervention phase (as opposed to the control phase), they will receive a 7-day, 8-hour intervention with an electric blanket set at +5±1°C above room temperature.

Treatment:

Device: Electric Blanket

Non-mild-heat group

No Intervention group

Description:

Participants will be randomized into groups A and B. There will be no additional sleep temperature intervention while the group is in the control period.