Effects of Sleep Body Temperature on Body Composition

NCT06648109 | Not Yet Recruiting

• 1 other identifier: JNUKY-2023-0126
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Blood pressure

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

  1month

Study Arms (2)

Mild-heat group

EXPERIMENTAL

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.

Device: Electric Blanket

Non-mild-heat group

NO INTERVENTION

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.

Interventions

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.

Mild-heat group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jinan University Guangzhou: lead

Study Sites (1)

Jinan University Guangzhou

Guangzhou, Select A State, 510632, China

Location

Central Study Contacts

Fangfang Zeng

CONTACT

+86 13822285635; zengffjnu@126.com

Jiamin Qiu

CONTACT

+86 178196663352; adniminday@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: October 20, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)