| Registry | NCT06648109 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, prevention |
| Enrollment | 40 (Estimated) |
| Sponsor | Jinan University Guangzhou (Other) |
| Conditions | Blood Pressure Check (Hypertension Screening), Heart Rate, Aldosterone Disorder |
| Interventions | Electric Blanket (Device) |
| Dates | start 2024-10-20 (estimated), primary completion 2025-01-30 (estimated), completion 2025-01-30 (estimated), first posted 2024-10-18, last updated 2024-10-18 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Blood Pressure Check (Hypertension Screening) All trials for Heart Rate All trials of Electric Blanket
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mild-heat group | Experimental | Device: Electric Blanket | 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. |
| 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. |
Sex: All, ages: 18 Years to 30 Years, 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Jinan University Guangzhou | Guangzhou, Select A State | China |