Smart Textile Sensor System for Health Monitoring
1 other identifier
observational
200
1 country
3
Brief Summary
The present study will investigate a set of biomedical sensors with a wireless data communication system and evaluate the sensors' recording quality. The sensors and wearable wireless system have been approved by Food and Drug Administration (FDA) for recording Electrocardiography (ECG), Trans Thoracic Impedance (TTI), Heart Sounds and Acitigraphy. The sensors and wireless system will be used along with conventional sensor systems (as intended to be used).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2014
CompletedFirst Submitted
Initial submission to the registry
July 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2024
CompletedNovember 8, 2023
November 1, 2023
9.6 years
July 20, 2022
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Efficacy against gold standard devices
Efficacy of SimpleSense Electrocardiograph (ECG) signals against a Holter monitor: Simultaneous ECG signal capture from SimpleSense and Holter monitor. Obtain correlation (with 95% confidence interval) between amplitudes of simultaneously recorded ECG signals from SimpleSense and ECG signals from Holter monitor.
1 year
Efficacy against gold standard devices
Efficacy of SimpleSense Impedance cardiograph (ICG) signals against gold standard: Simultaneous bioimpedance and ICG signal capture from SimpleSense and Bioimpedance recorder. Obtain correlation (with 95% confidence interval) between amplitudes of simultaneously recorded bioimpedance and ICG signals from SimpleSense and signals from Bioimpedance recorder.
1 year
Efficacy against gold standard devices
Efficacy of SimpleSense Heart Sound signals against gold standard devices: Simultaneous Heart Sound signal capture from SimpleSense and Digital Stethoscope. Obtain correlation (with 95% confidence interval) between amplitudes of simultaneously recorded Heart Sound signal capture from SimpleSense and Digital Stethoscope.
1 year
Efficacy against gold standard devices
Efficacy of SimpleSense Posture against gold standard devices: Simultaneous 3 axis accelerometer signal capture from SimpleSense and Visual record of posture change. Obtain correlation (with 95% confidence interval) between amplitudes of simultaneously recorded 3 axis accelerometer signal capture from SimpleSense and Visual record of posture change.
1 year
Secondary Outcomes (1)
Blood pressure algorithm build
1 year
Study Arms (1)
Cardiac health subjects
Subjects over 18 years of age. Subject should satisfy any one of the following: * Healthy subject with no pre-existing conditions. * Subject with prehypertension * Subject with hypertension * Subject undergoing dialysis
Interventions
The Nanowear SimpleSense is a non-invasive, wearable and portable medical device for evaluation and monitoring of cardiopulmonary condition. It utilizes physiologic and biometric sensors, SAU, and software system with a suite of algorithms to monitor patient. The parameters include: two vectors of ECG, two vectors of impedance cardiography, thoracic impedance, respiration, heart sounds, and actigraphy and postures. The device is comprised of a wearable device made of an elastomeric harness comprising of active and passive Nanosensors, heart sound sensor, connector to electrically connect the sensors to SAU, it comprises of Inertial Measurement Unit, analog front end, processing unit, storage unit, power supply, and a wireless module, and a software system equipped with the suite of algorithms to monitor heart. The signals are recorded by SAU, transferred to the iPhone over Bluetooth, which later transfers the data to a secure website over an internet connection Wi-fi or mobile network.
Eligibility Criteria
200 willing subjects evenly spread across age range, gender, BMI.
You may qualify if:
- Healthy subject with no pre-existing conditions.
- Subject with prehypertension
- Subject with hypertension
- Subject undergoing dialysis
You may not qualify if:
- Pregnant women
- Subjects with implantable cardiac devices (for example, pacemaker or internal cardioverter defibrillator).
- Subjects with arrhythmia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanowear Inc.lead
Study Sites (3)
Clincept
Atlanta, Georgia, 31904, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
Nanowear R&D
State College, Pennsylvania, 16803, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2022
First Posted
July 26, 2022
Study Start
October 23, 2014
Primary Completion
June 9, 2024
Study Completion
June 9, 2024
Last Updated
November 8, 2023
Record last verified: 2023-11