Aldosterone Disorder, Blood Pressure Check (Hypertension Screening), Heart Rate
Conditions
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.
Interventions
DEVICEElectric 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.
Sponsors
Jinan University Guangzhou
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 1month | Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure. |
Countries
China
Contacts
Primary ContactFangfang Zeng
Backup ContactJiamin Qiu
Outcome results
None listed