Healthy PeopleNCT05095753
Data Collection of Heart Rate and Blood Pressure
An observational study of Healthy People, run by MindMics Inc at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Healthy People
- What is being tested?
- Earbud
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 14 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Healthy cohort
Who may be able to join
- Ages 18-90
- No gender restrictions
- Cognitive ability to consent
Who cannot join
- Patients with pacemakers
- Patients with irregular heart rhythms
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MindMics, Inc.
Cambridge, Massachusetts, 02140
Anna Barnacka, PhD, 857-210-9181, anna.barnacka@mindmics.com
maureen coyle, 9787012626, maureen.coyle@mindmics.com
About this study
The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).
Read the 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.
- Conditions
- Healthy People
- Being tested
- Earbud
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarbudDevice
In ear headphone with embedded infrasonic hemodynography technology
What is being measured
The primary outcome is the main question the study is designed to answer.
RR Interval from ECG signal
Time in milliseconds between successive ECG R peaks
Measured: 20 minutes
Inter-beat Interval from earbud signal
Time in milliseconds between successive peaks in earbud signal
Measured: 20 minutes
Systolic and diastolic blood pressure from blood pressure cuff
Value of blood pressure in mmHg reported by a blood pressure cuff
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Nov 2019
- Primary completion14 Nov 2021 (estimated)
- Study completion14 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PeopleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MindMics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095753
- Sponsor's protocol ID
- 120190480
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of Heart Rate and Blood Pressure
- ClinicalTrials.gov ID
- NCT05095753
- Acronym / sponsor ID
- 120190480
- Conditions
- Healthy People
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- MindMics IncIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 14 Nov 2021 (estimated)
- Study completion
- 14 Nov 2021 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy cohort
Key inclusion criteria (3 listed)
- Ages 18-90
- No gender restrictions
- Cognitive ability to consent
Key exclusion criteria (2 listed)
- Patients with pacemakers
- Patients with irregular heart rhythms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EarbudIn ear headphone with embedded infrasonic hemodynography technology | Device | – |
Primary outcome
RR Interval from ECG signal
Time frame: 20 minutes
Time in milliseconds between successive ECG R peaks
Inter-beat Interval from earbud signal
Time frame: 20 minutes
Time in milliseconds between successive peaks in earbud signal
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No. No plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People, run by MindMics Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Barnacka (857 210 9181, anna.barnacka@mindmics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RR Interval from ECG signal (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.