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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19
• Intervention / Treatment: 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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 positive patients aged 55 and above, and resident of any state in the United States.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Evaluating the feasibility of a virtual trial to collect physiological data with the Hexoskin Platform.	Up to six months
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.	Assessing the quality of the data collected with Hexoskin with the Hexoskin quality assessment channels from patients recruited during a virtual trial.	Up to six months
Ensure adequate patient compliance, qualified as > 75% of total recording hours completed, and > 75% of daily questionnaires completed.	Determine the participant's level of compliance with study procedures of the research protocol.	Up to six months
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).	Assessing the feasibility to use the data collected to build a predictive algorithm for the Hexoskin Remote Monitoring Platform.	Up to six months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): August 9, 2022
• Study Completion (Actual): August 9, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Hexoskin COVID-19 Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No