Blood Pressure Check (Hypertension Screening)NCT06648109
Effects of Sleep Body Temperature on Body Composition
A study testing Electric Blanket in people with Blood Pressure Check (Hypertension Screening) and Heart Rate, run by Jinan University Guangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Check (Hypertension Screening), Heart Rate, Aldosterone Disorder
- What is being tested?
- Electric Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants aged 18-30 years, inclusive of both male and female genders.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Electric Blanket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electric BlanketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electric Blanket |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start20 Oct 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure Check (Hypertension Screening)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan University Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangfang Zeng, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648109
- Sponsor's protocol ID
- JNUKY-2023-0126
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The experiment will be made public upon completion with the publication of the related paper, sharing: contact the researcher for a copy.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sleep Body Temperature on Body Composition
- ClinicalTrials.gov ID
- NCT06648109
- Acronym / sponsor ID
- JNUKY-2023-0126
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jinan University GuangzhouUniversity, hospital or other
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mild-heat group | Experimental | Device: Electric BlanketParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants aged 18-30 years, inclusive of both male and female genders.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electric BlanketParticipants 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. | Device | Mild-heat group |
Primary outcome
Blood pressure
Time frame: 1month
Including systolic blood pressure (SBP) and diastolic blood pressure (DBP), Includes office blood pressure, home blood pressure and ambulatory blood pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric Blanket in people with Blood Pressure Check (Hypertension Screening) and Heart Rate, run by Jinan University Guangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fangfang Zeng (+86 13822285635, zengffjnu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.