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COVID-19NCT04453891

Hexoskin Feasibility Study With COVID-19 Patients

An observational study of COVID-19, run by Nguyen Thu Ngan Trinh.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
COVID-19
What is being tested?
Monitoring physiological data with the Hexoskin smart shirt
Type of treatment
Medical device
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jul 2022to 9 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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).

Who cannot join

  • 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

About this study

Official title: 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.

Read the 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.

Conditions
COVID-19
Being tested
Monitoring physiological data with the Hexoskin smart shirt
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monitoring physiological data with the Hexoskin smart shirtDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to six months

  2. 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.

    Measured: Up to six months

  3. 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.

    Measured: Up to six months

  4. 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.

    Measured: Up to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start15 Jul 2022
  3. Primary completion9 Aug 2022
  4. Study completion9 Aug 2022

Why it stopped: Internal timeline was delayed, logistics delays

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453891
Sponsor's protocol ID
Hexoskin COVID-19 Study
Status last verified
Aug 2022
First submitted
29 Jun 2020
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Nguyen Thu Ngan Trinh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Up to six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04453891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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Hexoskin Feasibility Study With COVID-19 Patients | AzTrials