Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
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|ClinicalTrials.gov Identifier: NCT04772170|
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2021
Last Update Posted : April 21, 2021
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.
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.
Healthy adults who have enrolled in a challenge study.
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|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
Current Challenge Study Participant
Current participation in a respiratory virus challenge study at the NIH CC
- 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.
- 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.
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
|United States, Maryland|
|National Institutes of Health Clinical Center|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Alison Han, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|