Standardized Home Spirometry Method in Normal Population

NACompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

January 17, 2022

Study Completion Date

January 17, 2022

Conditions
Mobile ApplicationsHealthy VolunteersFeasibility Study
Interventions
DEVICE

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."

Trial Locations (1)

63110

Washington University in St. Louis, St Louis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

lead

Washington University School of Medicine

OTHER