Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention
NCT ID: NCT06567106
Last Updated: 2024-11-04
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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RECRUITING
NA
6 participants
INTERVENTIONAL
2024-10-10
2027-10-10
Brief Summary
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The main question it aims to answer is:
How will ultrasound affect the cardiac function?
Researchers will： Apply ultrasound to the body and observe cardiac functions.
Participants will:
Receive ultrasound application and physiological signal monitoring.
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Detailed Description
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The primary outcome is heart rhythm. It will be measured by electrocardiogram. The secondary primary outcome is the incidence of treatment-related adverse events. It will be measured by electrocardiogram and observation.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Ultrasound application at minimal intensity
Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm².
Ultrasound application
Apply ultrasound to the participant within a safe range.
Ultrasound application at mild intensity
Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm².
Ultrasound application
Apply ultrasound to the participant within a safe range.
Ultrasound application at medium intensity
Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm².
Ultrasound application
Apply ultrasound to the participant within a safe range.
No ultrasound application
No ultrasound application to the participant.
No ultrasound application
No ultrasound application to the participant.
Interventions
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Ultrasound application
Apply ultrasound to the participant within a safe range.
No ultrasound application
No ultrasound application to the participant.
Eligibility Criteria
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Inclusion Criteria
* Aged between 18 and 65 years.
* Voluntary participation with signed informed consent.
* No history of cardiovascular disease.
Exclusion Criteria
* Individuals with implanted electronic devices such as pacemakers or defibrillators.
* Those on medications that significantly alter heart rate, such as beta-blockers, unless under stable control for a specific period.
* Individuals at risk of severe complications.
18 Years
65 Years
MALE
Yes
Sponsors
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ShanghaiTech University
OTHER
Responsible Party
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Bingbing Cheng
Assistant Professor
Locations
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Bingbing Cheng
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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Q2024-004
Identifier Type: -
Identifier Source: org_study_id
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