Data Collection of Heart Rate and Blood Pressure

October 22, 2021 updated by: MindMics Inc
The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy cohort

Description

Inclusion Criteria:

  • Ages 18-90
  • No gender restrictions
  • Cognitive ability to consent

Exclusion Criteria:

  • Patients with pacemakers
  • Patients with irregular heart rhythms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MindMics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Anticipated)

November 14, 2021

Study Completion (Anticipated)

November 14, 2021

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 22, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 120190480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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