Recruiting

Digital Devices

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT04772170

Conditions

Influenza

Respiratory Virus

Coronavirus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04772170

Start date

Oct 23, 2023

Status verified date

Sep 4, 2026

Completion date

Jun 2, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

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

1. Able to provide informed consent.
2. Current, recent, or planned enrollment in a respiratory virus challenge study at the NIH Clinical Center.
3. Willing to wear devices as instructed.
4. Willing to participate in monitoring activities as instructed.
5. Willing to have monitoring data stored.
6. Willing to have monitoring data shared with protocol investigators at NIH, University of Washington, and University of Toronto.
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.

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, 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Current Challenge Study Participant

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

Primary outcome measure

  • 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. [ Time Frame: minimum of 9 days inpatient ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 9, 2026

Last verified

Sep 4, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-09.