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Protocol Details

Observational Digital Biomarker Discovery in Respiratory Virus Challenge Studies

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000291-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 65 Years

Referral Letter Required

Yes

Population Exclusion(s)

Fetuses;
Adults who are or may become unable to consent;
Pregnant Women;
Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Influenza;
Respiratory Virus;
Coronavirus

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Luca T. Giurgea, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 10 - CLINICAL CENTER BG RM 6D44
10 CENTER DR
BETHESDA MD 20892
(301) 538-5235
luca.giurgea@nih.gov

Rani S. Athota, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 15F1
Room 100
9000 Rockville Pike
Bethesda, Maryland 20892
(301) 594-0803
kotar@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04772170

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