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NCT05095753 Clinical Trial

Data Collection of Heart Rate and Blood Pressure

Healthy People Clinical Trial

Official title:
Data Collection of Heart Rate and Blood Pressure

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05095753
Other study ID # 120190480
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date November 14, 2021

Study information
Verified date October 2021
Source MindMics Inc
Contact Anna Barnacka
Phone 857 210 9181
Email anna.barnacka@mindmics.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).

Description:

MindMics is developing technology to enhance an individual's quality of life by continuously monitoring the heart rate, stress thereby allowing people to make better decisions regarding their health. MindMics has a working prototype of the ear buds which will perform all the conventional tasks earbuds do (listen to music, etc.), but, in addition, will measure your vital signs. The earbuds capture the sounds made by the various cardiac structures pulsing and moving blood.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date November 14, 2021
Est. primary completion date November 14, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Ages 18-90 - No gender restrictions - Cognitive ability to consent Exclusion Criteria: - Patients with pacemakers - Patients with irregular heart rhythms

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Earbud
In ear headphone with embedded infrasonic hemodynography technology

Locations
Country Name City State
United States MindMics, Inc. Cambridge Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
MindMics Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary RR Interval from ECG signal Time in milliseconds between successive ECG R peaks 20 minutes
Primary Inter-beat Interval from earbud signal Time in milliseconds between successive peaks in earbud signal 20 minutes
Primary Systolic and diastolic blood pressure from blood pressure cuff Value of blood pressure in mmHg reported by a blood pressure cuff 20 minutes
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