Design and Rationale of the Assessment of the MindMics Recording System

NCT05103579 | Completed

• 1 other identifier: Pro00096535
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

MindMics earbuds is a new technology designed enhance an individual's quality of life by continuously monitoring the heart rate, stress, and blood pressure allowing patients to make decisions regarding their health. MindMics has a working prototype of the ear buds which will perform all the conventional tasks of earbuds (listen to music, etc.), but, in addition, will measure heart rate, stress, blood pressure. The earbuds capture the sounds made by the various cardiac structures pulsing and moving blood. The sound is caused by the acceleration and deceleration of blood and the turbulence developed during rapid blood flow.

Conditions

Atrial Fibrillation; Arrythmia

Outcome Measures

Primary Outcomes (1)

• Performance of the MindMics device for detecting Atrial Fibrillation based on inter-beat intervals

  Sensitivity and specificity for detecting Atrial Fibrillation using inter-beat intervals and statistical measures based on inter-beat intervals

  30 minutes

Study Arms (2)

Patients with AFib

Patients with AFib

Device: MindMics

Normal patients

Normal patients without AFib

Device: MindMics

Interventions

MindMics DEVICE

Patients rhythms was recorded using MindMics device

Normal patients; Patients with AFib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 25 patients will be recruited for group 1 from inpatient or outpatient office visits. Approximately 25 patients will be recruited for group 2 prior to direct-current cardioversion allowing collection of data from before and after cardioversion to document differences in recordings during sinus rhythm after having successful cardioversion from atrial fibrillation.

You may qualify if:

• AFib

You may not qualify if:

• N/A

Sponsors & Collaborators

• MindMics Inc: lead

Study Sites (1)

Prisma Health

Sumter, South Carolina, 29150, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 2, 2021
• Study Start: March 24, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)