Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

NCT04772170 | Recruiting

• 2 other identifiers: 10000291000291-I
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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, were recently enrolled, or are scheduled to enroll in a challenge study. Design: Participants will stay at NIH for the duration of the challenge study (at least 9 days) and then will have outpatient follow-up visits (2-4). 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 a smartphone that records at all times to listen for coughing and changes in voice. Participants will perform tasks every 4 hours during the daytime. They will record themselves coughing, breathing in deeply, and reading aloud. They will take videos of their face. They will play a game to test their reflexes and focus. They will measure their head temperature with their smartwatch. For outpatient visits, participants will use one smartphone and the smartwatch to complete the above tasks. Participants will be sent a smartwatch to wear at home at night to collect additional healthy data. Participation will last the duration of each challenge study, and may range from 10 weeks to 2 years.

Conditions

Influenza; Respiratory Virus; Coronavirus

Keywords

Wearable Digital Device; Bed Sensor; Smartphone; Cough Count; Smartwatch; Natural History

Outcome Measures

Primary Outcomes (1)

• To correlate continuous cough sensor data to cough severity after challenge.To develop a predictive model for MMID and asymptomatic influenza infection using digital biomarkers.

  Cough is a known symptom of respiratory virus infections and can be quantified by objective measurements.Data from smart devices may be able to discern who gets sick with a respiratory virus and could be utilized as a diagnostic tool.

  minimum of 9 days inpatient

Secondary Outcomes (1)

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

  minimum of 9 days inpatient

Study Arms (1)

Current Challenge Study Participant

Current participation in a respiratory virus challenge study at the NIH CC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers currently enrolled in a respiratory virus challenge study

You may qualify if:

• 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, recent, or planned 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.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• \. Any condition that, in the opinion of the investigator, contraindicates participation in this study.
• Co-enrollment guidelines: Participants must be co-enrolled, planned for co-enrollment, or recently 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Influenza, Human; Coronavirus Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections

Study Officials

• Luca T Giurgea, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rani S Athota, Ph.D.

CONTACT

(301) 594-0803; rani.athota@nih.gov

Luca T Giurgea, M.D.

CONTACT

(301) 538-5235; luca.giurgea@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: February 26, 2021
• Study Start: October 23, 2023
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-09-10

Locations

US (1)