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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

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 in a challenge study.

Design:

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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Group/Cohort
Current Challenge Study Participant
Current participation in a respiratory virus challenge study at the NIH CC



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers currently enrolled in a respiratory virus challenge study
Criteria
  • 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 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 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.


Information from the National Library of Medicine

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


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Alison Han, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04772170    
Other Study ID Numbers: 10000291
000291-I
First Posted: February 26, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: February 22, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Wearable Digital Device
Bed Sensor
Smartphone
Cough Count
Smartwatch
Additional relevant MeSH terms:
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Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections