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Smart Textile Sensor System for Health Monitoring

NCT05473702 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 334

Last updated 2026-04-07

No results posted yet for this study

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).

Conditions

  • Heart Disease Chronic
  • Pulmonary Disease, Chronic Obstructive
  • Blood Pressure
  • Heart Rhythm Disorder

Interventions

DEVICE

Nanowear SimpleSense Wearable monitoring device

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.

Sponsors & Collaborators

  • Nanowear Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-23
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05473702 on ClinicalTrials.gov