Hexoskin Feasibility Study With COVID-19 Patients

Hexoskin

Status: Withdrawn

Conditions: COVID-19

Treatments: Device: Monitoring physiological data with the Hexoskin smart shirt

Study type: Observational

Funder types: Industry

Identifiers

NCT04453891

Hexoskin COVID-19 Study

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 55+ years old

Volunteers: No 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