Effects of Sleep Body Temperature on Body Composition

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.

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Key information

Conditions

Blood Pressure Check (Hypertension Screening) Aldosterone Disorder Heart Rate

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinan University Guangzhou

Guangzhou, Select A State, 510632, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electric blanket

Device

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.

Primary outcomes

Blood pressure

Time frame: 1month

Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

Fangfang Zeng

CONTACT

[email protected]

+86 13822285635

Jiamin Qiu

CONTACT

[email protected]

+86 178196663352

Sponsors and collaborators

Lead sponsor

Jinan University Guangzhou

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 18, 2024
Registry last updated: Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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