Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04772170

Recruitment Status : Enrolling by invitation

First Posted : February 26, 2021

Last Update Posted : April 21, 2021

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description

Brief Summary:

Background:

Respiratory viruses circulate throughout the year and around the globe. Wearable and sensor devices, like smartwatches, may be able to help monitor infectious diseases. Researchers want to use them to learn how respiratory viruses affect people in different ways.

Objective:

To use digital devices to collect data from participants in challenge studies that could indicate subtle changes in health during an infection that might otherwise go unnoticed.

Eligibility:

Healthy adults who have enrolled in a challenge study.

Design:

Participants will stay at NIH for at least 9 days and then they will have outpatient visits.

While at NIH, participants will wear a smartwatch at all times. It will record data like temperature, heart rate, breathing rate, and movements.

Participants will have 2 smartphones. One will be recording at all times to listen for coughing. Participants will use the other smartphone to check their vital signs. They will collect data like heart rate, temperature, and the level of oxygen in the blood every 4 hours during the daytime.

Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take pictures and videos of their face.

A bedside sensor will record participants while they sleep. It will record heart rate and breathing rate. It will also look at sleep activity, such as movements participants make during sleep and how deeply they sleep.

Participants sharing the same room will be exposed to the same challenge virus.

For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks.

Participation will last from 10 weeks to 1 year.

Condition or disease
Influenza Respiratory Virus Coronavirus

Show detailed description

Detailed Description:

Title:

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Study Description:

Wearable and sensor digital devices have the potential to be important tools in infectious diseases surveillance. In this study, digital devices will be used to evaluate responses before and after respiratory virus challenge on a separate NIH protocol. Participants already enrolled in a challenge study are eligible. All devices will be worn and/or used during the inpatient hospitalization and at outpatient follow-up visits. Participants will not be discharged home with any devices. These devices will be used to identify biomarkers associated with respiratory virus infection. We hypothesize that sensor collected data will correlate with symptom severity obtained by clinician assessment and participant report.

Objectives:

Primary: To correlate continuous cough sensor data to cough severity after challenge.

Secondary: To correlate continuous and noncontinuous vital sign sensor data to routine vital signs obtained by clinical staff.

Exploratory: To evaluate facial and body sensor data after challenge.

Endpoints:

Primary: Cough quantity:

1.Continuous cough measurements

Secondary: Vital signs:

Heart rate
Respiratory rate
Temperature
Pulse oximetry

Exploratory: Facial and body sensor data via quantitative measures of:

1. Forced nasal inspiration

2 Forced cough

3. Facial imaging

4. Sleep monitoring

5. Activity monitoring

6. Reading aloud

7. Blood pressure

Study Population:

N=50 adult healthy volunteers enrolled in LID CSU respiratory virus challenge studies.

Description of Sites/Facilities Enrolling Participants:

Participants will be enrolled at the NIH Clinical Center (CC). This study will take place at the NIH CC in the Special Clinical Studies Unit or other appropriate designated clinical area for the inpatient hospitalization and in the OP8 clinic or other appropriate designated clinical area for outpatient visits.

Study Duration:

Approximately 3 years from start of enrollment to completion of data analyses.

Participant Duration:

Approximately 10 weeks through 1 year depending on the challenge study. This includes a minimum 9-day inpatient hospitalization for respiratory virus challenge through the follow-up visit 8 weeks to 1 year after discharge.

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	50 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
Estimated Study Start Date :	April 26, 2021
Estimated Primary Completion Date :	November 29, 2024
Estimated Study Completion Date :	November 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Current Challenge Study Participant Current participation in a respiratory virus challenge study at the NIH CC

Outcome Measures

Primary Outcome Measures :

To correlate continuous cough sensor data to cough severity after challenge. [ Time Frame: minimum of 9 days inpatient ]
Cough is a known symptom of respiratory virus infections and can be quantified by objective measurements.

Secondary Outcome Measures :

To correlate continuous and noncontinuous vital signs sensor data to routine vital signs obtained by clinical staff. [ Time Frame: minimum of 9 days inpatient ]
Vital signs are routinely measured in challenge studies and are also routinely collected from digital devices. Vital sign changes can be associated with respiratory virus infections.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy volunteers currently enrolled in a respiratory virus challenge study

Criteria

INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Able to provide informed consent.
Current enrollment in a respiratory virus challenge study at the NIH Clinical Center.
Willing to wear devices as instructed.
Willing to participate in monitoring activities as instructed.
Willing to have monitoring data stored.
Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
Willing to have select clinical data from the challenge study such as vital signs, viral shedding, pulmonary function test and/or spirometry results, and clinical symptoms data shared with investigators at University of Washington and University of Toronto.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Co-enrollment guidelines: Participants must be co-enrolled in a challenge study. Co-enrollment in other studies is restricted but may take place after study staff notification and only with approval of the principal investigator or designee.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772170

Locations

Layout table for location information

United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Layout table for investigator information

Principal Investigator:	Alison Han, M.D.	National Institute of Allergy and Infectious Diseases (NIAID)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Layout table for additonal information

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT04772170
Other Study ID Numbers:	10000291 000291-I
First Posted:	February 26, 2021 Key Record Dates
Last Update Posted:	April 21, 2021
Last Verified:	February 22, 2021

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):


Wearable Digital Device Bed Sensor Smartphone Cough Count Smartwatch

Additional relevant MeSH terms:

Layout table for MeSH terms

Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections

To Top