This study is NOT currently recruiting participants.
Number
000291-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Recruitment has not started 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)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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.
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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.
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.
Principal Investigator
Referral Contact
For more information: