InfluenzaNCT04772170
Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
An observational study of Influenza and Respiratory Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Respiratory Virus, Coronavirus
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 2 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers currently enrolled in a respiratory virus challenge study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
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.
Read more
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.
Read the detailed description
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 recently enrolled, currently enrolled, or planned for enrollment in a challenge study are eligible. Devices will be worn and/or used during the inpatient hospitalization and at outpatient follow-up visits. Participants may be sent smartwatches at home to collect additional baseline or healthy data. Devices may collect data on coughing, speech, heart rate, heart rhythm, sweating, and temperature to identify digital biomarkers associated with respiratory virus infection. The correlation between digital device measurement data and clinical data, particularly on cough, will be determined. We hypothesize that sensor-collected data will correlate with symptom severity obtained by clinician assessment and participant report. We also hypothesize that digital biomarkers can predict influenza infection and can be used to develop a predictive model.
Objectives:
- Primary:
- To correlate continuous cough sensor data to cough severity after challenge.
- To develop a predictive model for mild-moderate influenza disease (MMID) and influenza infection using digital biomarkers
- Secondary: To correlate continuous and noncontinuous vital sign sensor data to routine vital signs obtained by clinical staff.
- Exploratory:
- To evaluate body sensor data after challenge.
- To correlate digital biomarker data to biological biomarker data.
Endpoints:
Primary:
- Cough quantity: -Continuous cough measurements
- Infection
- Defined as:
- MMID (positive PCR for influenza and >=1 symptoms)
- Flu (positive PCR for influenza or convalescent four-fold increase in serum antibodies to the hemagglutinin (HA) or neuraminidase (NA) of the challenge virus and >=1 symptoms)
- Influenza infection (positive PCR for influenza)
- Using predictor variables such as:
- Smartwatch photoplethysmography (PPG) determined heart rate
- Smartwatch electrodermal activity (EDA) determined sweating
- Smartwatch determined temperature
- Smartwatch Electrocardiogram (ECG) monitoring
- Audio voice recording Secondary: Vital signs:
- Heart rate
- Respiratory rate
- Temperature
Exploratory:
Correlations between digital biomarker data and biological biomarker data (e.g. antibody titers)
- Conditions
- Influenza, Respiratory Virus, Coronavirus
- Keywords
- Wearable Digital Device, Bed Sensor, Smartphone, Cough Count, Smartwatch, Natural History
- Medical subject headings
- Influenza, Human, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Current Challenge Study Participant | Current participation in a respiratory virus challenge study at the NIH CC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: minimum of 9 days inpatient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start23 Oct 2023
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luca T Giurgea, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772170
- Sponsor's protocol ID
- 10000291
- Other IDs
- 000291-I
- Status last verified
- 4 Sep 2026
- First submitted
- 25 Feb 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies
- ClinicalTrials.gov ID
- NCT04772170
- Acronym / sponsor ID
- 10000291
- Conditions
- Influenza, Respiratory Virus, Coronavirus
- Keywords
- Wearable Digital Device, Bed Sensor, Smartphone, Cough Count, Smartwatch, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 recently enrolled, currently enrolled, or planned for enrollment in a challenge study are eligible. Devices will be worn and/or used during the inpatient hospitalization and at outpatient follow-up visits. Participants may be sent smartwatches at home to collect additional baseline or healthy data. Devices may collect data on coughing, speech, heart rate, heart rhythm, sweating, and temperature to identify digital biomarkers associated with respiratory virus infection. The correlation between digital device measurement data and clinical data, particularly on cough, will be determined. We hypothesize that sensor-collected data will correlate with symptom severity obtained by clinician assessment and participant report. We also hypothesize that digital biomarkers can predict influenza infection and can be used to develop a predictive model.
Objectives:
- Primary:
- To correlate continuous cough sensor data to cough severity after challenge.
- To develop a predictive model for mild-moderate influenza disease (MMID) and influenza infection using digital biomarkers
- Secondary: To correlate continuous and noncontinuous vital sign sensor data to routine vital signs obtained by clinical staff.
- Exploratory:
- To evaluate body sensor data after challenge.
- To correlate digital biomarker data to biological biomarker data.
Endpoints:
Primary:
- Cough quantity: -Continuous cough measurements
- Infection
- Defined as:
- MMID (positive PCR for influenza and >=1 symptoms)
- Flu (positive PCR for influenza or convalescent four-fold increase in serum antibodies to the hemagglutinin (HA) or neuraminidase (NA) of the challenge virus and >=1 symptoms)
- Influenza infection (positive PCR for influenza)
- Using predictor variables such as:
- Smartwatch photoplethysmography (PPG) determined heart rate
- Smartwatch electrodermal activity (EDA) determined sweating
- Smartwatch determined temperature
- Smartwatch Electrocardiogram (ECG) monitoring
- Audio voice recording Secondary: Vital signs:
- Heart rate
- Respiratory rate
- Temperature
Exploratory:
Correlations between digital biomarker data and biological biomarker data (e.g. antibody titers)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Current Challenge Study Participant | – | –Current participation in a respiratory virus challenge study at the NIH CC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers currently enrolled in a respiratory virus challenge study
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
To correlate continuous and noncontinuous vital signs sensor data to routine vital signs obtained by clinical staff.
Time frame: minimum of 9 days inpatient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca T Giurgea, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Respiratory Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rani S Athota, Ph.D. ((301) 594-0803, rani.athota@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.