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Hexoskin Feasibility Study With COVID-19 Patients | Clinical Trials | Clareo Health

WITHDRAWN

Hexoskin Feasibility Study With COVID-19 Patients

Evaluating the Feasibility of Monitoring Symptomatic COVID-19 Patients, and Predicting Disease Progression Using a Validated Digital Health Program

NCT04453891•Nguyen Thu Ngan Trinh

View on ClinicalTrials.gov

Summary

This pilot study aims to investigate the feasibility of using Hexoskin cardiorespiratory and activity data, as well as patient symptomatology, to provide an AI model for disease progression that will be at the service of the clinical team to recommend the best customized and evolving care trajectory for each patient.

Detailed Description

The following protocol proposes a mixed methods pilot study, whereby the immediate purpose is to generate quantifiable information regarding the feasibility of a virtual trial with the Hexoskin Platform, collection of data quality in COVID-19 patients, and values for algorithm construction. In essence, sixteen participants with a confirmed COVID-19 diagnosis will be invited to wear the Hexoskin biometric garment during the course of several hours per week, over a period of 28 days. In addition to the biometric data collection, participants will be invited to complete four questionnaires. The biometric data will be combined to the sociodemographic information and patient symptomatology to construct an algorithm which can accurately predict patient outcomes.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Minimum waist size of 24 inches, and maximum waist size of 45 inches
•Confirmed COVID-19 diagnosis from a licensed healthcare practitioner
•Permanent resident or citizen of the United States
•Access to a smartphone
•Access to a functional email
•Access to a thermometer
•Access to a measuring tape
•Experiencing at least three of the following COVID-19 symptoms (fever, cough, difficulty breathing, intense fatigue, sudden loss of smell and/or taste without nasal congestion, sore throat, headache, aching muscles, loss of appetite, diarrhea).

Exclusion Criteria

•Hexoskin should not be used by people with allergies to the following materials: polyester, synthetic fibers. Usage must be stopped if the product causes skin irritation or rashes.
•Hexoskin should not be used by people with Pacemakers or Implantable Cardioverter-Defibrillator (ICD) devices.
•Hexoskin must not be used simultaneously with a Holter Monitor, as the equipment would interfere with the placement of the Hexoskin sensors.
•Hexoskin must not be used in an MRI machine as it contains metallic parts.
•Individuals who do not fit any of the Hexoskin Shirts sizes (Men: between 2XS - 6XL, Women: between 2XS - 4XL).
•Individuals who have a documented medical condition or illness requiring intensive medical treatment.
•Women of Childbearing Potential whom are not using effective contraceptive measures

Key Dates

Start Date

July 15, 2022

Primary Completion Date

August 9, 2022

Completion Date

August 9, 2022

Last Updated

August 11, 2022

Conditions

COVID-19

Interventions

Monitoring physiological data with the Hexoskin smart shirt

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hexoskin Feasibility Study With COVID-19 Patients

Inclusion Criteria

Exclusion Criteria

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