A Wearable, Battery-free Screening System for SARS-CoV-2, the Virus Causing COVID-19 Infection

September 20, 2024 updated by: University of Nebraska
The corona virus disease (COVID) pandemic has highlighted the importance of rapid, readily available screeners and diagnostics to identify infected individuals. Recent studies have demonstrated that portable electronic nose sensing devices can detect volatile organic compounds (VOCs). These compounds are end products of human metabolism or of enteric bacteria and are excreted through the skin or exhaled breath. Importantly, the sensing devices can be adapted into a wearable device providing continuous monitoring. Our goal is to develop a battery-free, electronic nose sensor to serve as a screener and detect VOC patterns associated to patients with symptomatic and asymptomatic COVID-19 without being invasive. To test the screening ability, devices will be worn by COVID-19 positive and negative patients hospitalized at Nebraska Medicine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Purpose. This study will assess the feasibility of using an electronic nose to detect signals indicating infection with severe acute respiratory distress syndrome corona virus-2 (SARS-CoV-2). Five different prototypes of electronic nose will be used that would be deployed differently: 1) a patch, 2) clipped to a garment neckline, 3) clipped to a garment waistline, 4) resting on a bedside table, and 5) integrated into a facemask. Data will be collected over a three day period to determine the quality of the smell-print signals collected by the different deployment regimes. Eligibility. Subjects admitted to University of Nebraska Medical Center (UNMC) with definite or suspected SARS-CoV-2 infection will be eligible. Subjects must have access to a smart phone and be well enough to engage in the active data collection. The goal is to enroll 30 SARS-CoV-2 infected and 30 uninfected individuals. Eligibility of controls will be extended to patients admitted to UNMC with other respiratory problems including chronic obstructive pulmonary disease (COPD) exacerbation, pneumonia and congestive heart failure if needed. Adults (19 years and older) are eligible. Subjects with allergic reactions to components of the devices will be excluded. Interventions and evaluations. Informed consent will be obtained remotely following which an app will be downloaded to their phone. A kit will be delivered to the patients room containing the five devices. The app will support: instruction on use of the devices, reminders to collect data every 2 hours between 08:00 and 20:00, and access to study personnel for support as needed. The app will transmit smell prints from the 5 devices to a secure cloud-based database. The study coordinator will oversee subject education and deployment of the devices by phone/facetime. Subjects will be instructed on use of the devices, which they will self-deploy in positions that do not interfere with any medical equipment. The patch, clip-ons and bedside sensor will be worn continuously from 08:00 to 20:00. The mask will be placed for 5 minutes before each data collection, which will be timed by the phone app. The mask can then be removed until the next data collection. Smell-print data will be collected for three days. Following this, the devices will be replaced into the kit box and collected by the nursing staff. Clinical data will be collected from the electronic health record. Follow up. Following completion of the study, subjects will be asked to complete a brief questionnaire on the experience and asked about their willingness to be contacted for further interviews.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult (age >18) subjects admitted to the hospital for possible COVID-19.

Description

Inclusion Criteria:

°Admission for definite or suspected SARS-CoV-2 infection with mild to moderate symptoms and clinical features.

If insufficient numbers of suspected cases who test negative, individuals admitted with other respiratory problems: COPD exacerbation, viral pneumonia, congestive heart failure who test negative for SARS-CoV-2 will be eligible as controls.

  • Able to give informed consent.
  • Access to a smartphone capable of downloading the study app and of collecting and transmitting study data.
  • Ability to comply with study procedures.
  • Ability to self-deploy the study devices and collect study data.

Exclusion Criteria:

  • Inability to give informed consent.
  • Allergic history to components of study devices,
  • Inability to participate in study procedures.
  • Severe disease or admission to a critical care unit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
nose smell-print
Time Frame: at enrollment
nose smell-print. This is recorded as a set of impedances, one from each sensor filament. This results in an 8-dimensional vector that will be recorded for each subject. The vectors will then be related to diagnostic category (SARS-CoV-2 positive vs. negative). This will be determined separately for each of the sensor devices.
at enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stability of smell print
Time Frame: three days
8-dimensional smell prints will be recorded at approximately 2 hour intervals for waking hours over three days.
three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nebraska

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chad L Vokoun, MD, UNMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0027-21-EP

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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