Evaluating Infrasonic Hemodynography

Coronary Artery Disease Clinical Trial

Official title:

Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636892
• Other study ID #: 20-7677
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Scripps Health
• Contact: Carly Waldman, MD
• Phone: 858-537-7792
• Email: waldman.carly[@]scrippshealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

Description:

This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Normal Sinus Rhythm

• LV systolic function >53%

Exclusion Criteria:

• 1. Known history of carotid artery disease

• 2. Moderate or greater valvular disease in Group 1

• 3. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)

• 4. Active arrhythmia

• 5. Reduced Ejection Fraction (< 35%) other than Group 4

• 6. Hearing loss

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Failure, Systolic
• Hypertension, Pulmonary
• Mitral Regurgitation
• Mitral Valve Insufficiency
• Pulmonary Hypertension

Intervention

Other:
• MindMics earbud
Novel noninvasive wearable infrasound sensor

Locations

Country	Name	City	State
United States	Scripps Health	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infrasound Hemodynography	Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals	1 year

External Links

•   Hearables: Multimodal physiological in-ear sensing
•   Wearable PPG prediction of cardiac output from arterial line measurement in a swine model