9
Participants
Start Date
January 20, 2021
Primary Completion Date
January 17, 2022
Study Completion Date
January 17, 2022
Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter
"Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded into an Android Tablet, an FDA approved Bluetooth spirometer, an FDA approved pulse oximeter. HIPAA compliant data will be sent to an Investigational IT dashboard maintained at the Central Monitoring Institute Server.~Volunteers will train in-center or remotely \& perform baseline testing with the SHS method along with a baseline laboratory-based spirometry test (if practicable).~Pre-Surveillance Phase: Daily home spirometry method testing for 4 to 10 weeks to enable normal range calibration.~Surveillance Phase: At least weekly home spirometry method testing for 2-10 months of participation. Volunteers will maintain a test log during study team directed SHS software pathway functionality testing."
Washington University in St. Louis, St Louis
Collaborators (1)
Mallinckrodt
INDUSTRY
Washington University School of Medicine
OTHER