RECRUITING

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

Quick Facts

Study Start:2023-10-23
Study Completion:2025-06-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04772170

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able to provide informed consent.
  2. 2. Current enrollment in a respiratory virus challenge study at the NIH Clinical Center.
  3. 3. Willing to wear devices as instructed.
  4. 4. Willing to participate in monitoring activities as instructed.
  5. 5. Willing to have monitoring data stored.
  6. 6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
  7. 7. 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.
  1. 1. Any condition that, in the opinion of the investigator, contraindicates participation in this study.

Contacts and Locations

Study Contact

Rani S Athota, Ph.D.
CONTACT
(301) 594-0803
kotar@mail.nih.gov
Luca T Giurgea, M.D.
CONTACT
(301) 538-5235
luca.giurgea@nih.gov

Principal Investigator

Luca T Giurgea, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Luca T Giurgea, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

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 Registration Dates

Study Start Date2023-10-23
Study Completion Date2025-06-02

Study Record Updates

Study Start Date2023-10-23
Study Completion Date2025-06-02

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Influenza
  • Respiratory Virus
  • Coronavirus