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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure. | 1month |
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Inclusion Criteria:
- Participants aged 18-30 years, inclusive of both male and female genders.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fangfang Zeng | Contact | +86 13822285635 | zengffjnu@126.com | |
| Jiamin Qiu | Contact | +86 178196663352 | adniminday@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan University Guangzhou | Guangzhou | Select A State | 510632 | China |
The experiment will be made public upon completion with the publication of the related paper, sharing: contact the researcher for a copy.
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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.
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