Data Collection of Heart Rate and Blood Pressure | NCT05095753

Studies
Data Collection of Heart Rate and Blood Pressure

NCT05095753

Sponsor

MindMics Inc

Status

Unknown status

Last Update Posted

Oct 27, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Healthy People

Interventions

Earbud

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2019Actual

Primary Completion Date

Nov 14, 2021Estimated

Completion Date

Nov 14, 2021Estimated

First Submitted Date

Oct 7, 2021

First Submission Date that Met QC Criteria

Oct 22, 2021

First Posted Date

Oct 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2021

Last Update Posted Date

Oct 27, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Earbud	Device	In ear headphone with embedded infrasonic hemodynography technology

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 18-90
No gender restrictions
Cognitive ability to consent

Exclusion Criteria:

Patients with pacemakers
Patients with irregular heart rhythms

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy cohort

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anna Barnacka	Contact	857 210 9181		anna.barnacka@mindmics.com
maureen coyle	Contact	9787012626		maureen.coyle@mindmics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MindMics, Inc.	Recruiting	Cambridge	Massachusetts	02140	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided