Investigation of Cardiac Function Following Low-Intensity Ultrasound Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Function
• Intervention / Treatment: Other: Ultrasound application; Other: No ultrasound application

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bingbing Cheng, Ph.D.; Phone Number: +8620685173; Email: chengbb@shanghaitech.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Bingbing Cheng
    • Contact: Bingbing Cheng, Ph.D.; Email: chengbb@shanghaitech.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound application at minimal intensity; Apply minimal-intensity ultrasound to the participant. The intensity is below 2 W/cm².	Other: Ultrasound application; Apply ultrasound to the participant within a safe range.
Experimental: Ultrasound application at mild intensity; Apply mild-intensity ultrasound to the participant. The intensity is below 3 W/cm².	Other: Ultrasound application; Apply ultrasound to the participant within a safe range.
Sham Comparator: Ultrasound application at medium intensity; Apply medium-intensity ultrasound to the participant. The intensity is below 5 W/cm².	Other: Ultrasound application; Apply ultrasound to the participant within a safe range.
Sham Comparator: No ultrasound application; No ultrasound application to the participant.	Other: No ultrasound application; No ultrasound application to the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rhythm.	Monitor participants' electrocardiogram before, during and after ultrasound application. Calculate heart rate from the electrocardiogram signal. The change of heart rate is calculated as the rate of change relative to the baseline heart rate. Aggregate the data and do statistical analysis. Data will be presented as mean with standard deviations.	Throughout the intervention, an average of 1 hour.
Incidence of treatment-related adverse events.	The incidence of treatment-related adverse events includes both minor (such as localized discomfort, transient arrhythmias, mild chest pain, short-term dizziness, nausea, and temporary shortness of breath) and severe adverse events (including sustained arrhythmias, new-onset heart failure, significant myocardial injury, embolic events, or death).	Baseline, during the intervention (an average of 1 hour) and immediately after the intervention (same day, approximately 1 hour after baseline).

Collaborators and Investigators

• Sponsor: ShanghaiTech University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): October 10, 2027
• Study Completion (Estimated): October 10, 2027

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Cardiac function; Heart
• Other Study ID Numbers: Q2024-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No