Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-10-20
2025-01-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Mild-heat group
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.
Electric 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.
Non-mild-heat group
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.
No interventions assigned to this group
Interventions
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Electric 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
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Jinan University Guangzhou
OTHER
Responsible Party
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Fangfang Zeng
Associate Professor
Locations
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Jinan University Guangzhou
Guangzhou, Select A State, China
Countries
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Central Contacts
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Other Identifiers
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JNUKY-2023-0126
Identifier Type: -
Identifier Source: org_study_id
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