Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

ShanghaiTech University

Status: Enrolling

Conditions: Cardiac Function

Treatments: Other: Ultrasound application; Other: No ultrasound application

Study type: Interventional

Funder types: Other

Identifiers

NCT06567106

Q2024-004

Details and patient eligibility

About

The goal of this clinical trial is to investigate the influence of ultrasound on cardiac functrion.

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.

Full description

All procedures conducted in this trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures were approved by the Research Ethics Committee of ShanghaiTech University (Q2024-004).

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.

Enrollment: 6 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy individuals without significant diseases or chronic conditions.
• Aged between 18 and 65 years.
• Voluntary participation with signed informed consent.
• No history of cardiovascular disease.

Exclusion criteria

• Individuals with heart disease or other conditions that may affect cardiac function measurement.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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6 participants in 4 patient groups

Ultrasound application at minimal intensity

Experimental group

Description:

Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm².

Treatment:

Other: Ultrasound application

Ultrasound application at mild intensity

Experimental group

Description:

Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm².

Treatment:

Other: Ultrasound application

Ultrasound application at medium intensity

Sham Comparator group

Description:

Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm².

Treatment:

Other: Ultrasound application

No ultrasound application

Sham Comparator group

Description:

No ultrasound application to the participant.

Treatment:

Other: No ultrasound application