NCT05095753

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2 years

First QC Date

October 7, 2021

Last Update Submit

October 22, 2021

Conditions

Healthy People

Outcome Measures

Primary Outcomes (3)

  • RR Interval from ECG signal

    Time in milliseconds between successive ECG R peaks

    20 minutes

  • Inter-beat Interval from earbud signal

    Time in milliseconds between successive peaks in earbud signal

    20 minutes

  • Systolic and diastolic blood pressure from blood pressure cuff

    Value of blood pressure in mmHg reported by a blood pressure cuff

    20 minutes

Interventions

EarbudDEVICE

In ear headphone with embedded infrasonic hemodynography technology

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy cohort

You may qualify if:

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

You may not qualify if:

  • Patients with pacemakers
  • Patients with irregular heart rhythms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MindMics, Inc.

Cambridge, Massachusetts, 02140, United States

RECRUITING

Central Study Contacts

Anna Barnacka

CONTACT

857 210 9181anna.barnacka@mindmics.com

maureen coyle

CONTACT

9787012626maureen.coyle@mindmics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

October 27, 2021

Study Start

November 15, 2019

Primary Completion

November 14, 2021

Study Completion

November 14, 2021

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

No plan.

Locations

US(1)