About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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;
Trial design
Crossover
Treatments tested in this trial
Electric Blanket
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Blood pressure
Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.
Sponsors and contacts
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