Hexoskin Feasibility Study With COVID-19 Patients

Sponsor

Nguyen Thu Ngan Trinh (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04453891

Collaborator

(none)

Enrollment

Actual Duration (Days)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Device: Monitoring physiological data with the Hexoskin smart shirt

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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2022

Actual Primary Completion Date :

Aug 9, 2022

Actual Study Completion Date :

Aug 9, 2022

Outcome Measures

Primary Outcome Measures

Qualitative assessment of the feasibility of the Hexoskin Platform and Virtual Recruitment Process via three subjective feedback questionnaires provided to all patients enrolled in the study. [Up to six months]
Evaluating the feasibility of a virtual trial to collect physiological data with the Hexoskin Platform.
Ensure the collection of high-quality data during wake and sleep activities, registered as overall > 90% good quality cardiac data and overall > 90% good quality respiratory data per recording. [Up to six months]
Assessing the quality of the data collected with Hexoskin with the Hexoskin quality assessment channels from patients recruited during a virtual trial.
Ensure adequate patient compliance, qualified as > 75% of total recording hours completed, and > 75% of daily questionnaires completed. [Up to six months]
Determine the participant's level of compliance with study procedures of the research protocol.
Investigate the predictive power of Hexoskin physiological data, patient information and symptoms information to correctly classify patient disease progression quantified as the area under the receiver operator characteristics curve (AUC ROC > 0.70). [Up to six months]
Assessing the feasibility to use the data collected to build a predictive algorithm for the Hexoskin Remote Monitoring Platform.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nguyen Thu Ngan Trinh

Investigators

Principal Investigator: Nguyen Thu Ngan Trinh, 1-888-887-2044

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nguyen Thu Ngan Trinh, Clinical Applications Specialist, Hexoskin

ClinicalTrials.gov Identifier:

NCT04453891

Other Study ID Numbers:

Hexoskin COVID-19 Study

First Posted:

Jul 1, 2020

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 11, 2022