Standardized Home Spirometry Method in Normal Population
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|ClinicalTrials.gov Identifier: NCT03945500|
Recruitment Status : Not yet recruiting
First Posted : May 10, 2019
Last Update Posted : September 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mobile Applications Healthy Volunteers Feasibility Study||Device: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Evaluate the feasibility of using a Standardized Home Spirometry Method and associated Home Spirometry Mobile Medical Software (IT App and Server "Dashboard" to develop normal range values, to detect a value outside of the normal range, to evaluate a value outside of the normal range with a symptom survey and to download all data to a Central Monitoring Institute in a healthy volunteer population before beginning a full clinical trial in the lung transplant population.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Assessment of a Standardized Home Spirometry Method for Frequent Monitoring of Lung Function in a Normal Population|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2023|
Experimental: Standardized Home Spirometry (SHS) Method
The Standardized Home Spirometry Method consists of an Investigational Mobile Medical Application embedded into an Android Tablet, and FDA approved spirometer & pulse oximeter.
Participants will be trained with the Standardized Home Spirometry method and perform an initial home spirometry test session and a laboratory-based spirometry test.
Pre-surveillance Phase:Daily Standardized Home Spirometry Testing for up to 8 weeks to enable the Mobile Medical software application to generate volunteer specific normal range calibration.
Surveillance Phase: At least twice weekly Standardized Home Spirometry Testing.If a variance (outside of the participant's normal range) is detected, the participant will be prompted to complete a short symptom survey on the Android Pad. Participants may be directed to intentionally induce variances, symptoms, etc., in order to fully test and assess the Mobile Medical software pathways.
Device: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter
Standardized Home Spirometry 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 & perform baseline testing with the Standardized home spirometry method along with a baseline laboratory-based spirometry test.
Pre-Surveillance Phase: Daily home spirometry method testing for up to 8 weeks to enable normal range calibration.
Surveillance Phase: At least twice weekly home spirometry method testing for 4-10 months of participation.
Other Name: Baseline Laboratory Spirometry Testing
- Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Assess Home Spirometry reproducibility during pre-surveillance period. [ Time Frame: Up to 8 weeks ]Evaluate daily FEV1 variability between replicate measurements by summarizing between measurement %difference; Evaluate between day variability in highest FEV1 (FEV1 Max) variability by summarizing %Difference from FEV1 Max values and two SD (Standard Deviation) Coefficient of Variation (expected to be less than 30%) between FEV1 measurements during pre-surveillance period.
- Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Drift Assessment [ Time Frame: Up to 8 weeks ]Evaluate the functionality of the investigational Mobile Medical Software Application and associated IT Server Dashboard for statistically significant drift in relationship between %FEV1 Max or mean FEV1 Max over time and subsequent transition to Surveillance monitoring stage.
- Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Pathway Verification [ Time Frame: Through study completion, up to 10 months ]Evaluate the Mobile medical application software and associated IT server data processing pathways using % initial error rate (initial error rate and subsequent error rate, after any potential adjustments are made in mobile medical application if changes are required).
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): NCT03945500
|Contact: Kathy Dodds, RNfirstname.lastname@example.org|
|Contact: George Despotis, MDemail@example.com|
|Principal Investigator:||George Despotis, MD||Washington University School of Medicine|