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.
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.
Device: Monitoring physiological data with the Hexoskin smart shirt
Participants will be monitored using a validated biometric garment (Hexoskin smart shirt). Cardiorespiratory and activity data will be collected over a 28-day monitoring period. Participants will be invited to wear the shirt during the day and at night.
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
Nguyen Thu Ngan Trinh, Principal Investigator
1-888-887-2044