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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
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study was designed to evaluate the feasibility of using a Standardized Home Spirometry (SHS) Method to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data in normal volunteers prior to evaluation and use on a larger scale for lung transplant recipients. The Standardized Home Spirometry (SHS) Method consists of a FDA-approved Bluetooth Spirometry unit, FDA approved Bluetooth Pulse Oximeter and an Android-based Tablet which is embedded with an investigational Home Spirometry Mobile Medical Software Application for data and symptom survey collection and transmission over secure WiFi or cellular connectivity in HIPAA compliant fashion (labeled only with a date/time and machine ID stamp) to an associated investigational IT Server Dashboard at the Central Monitoring Institute Server at Washington University in St. Louis.

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

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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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age (18 years old or older)
  2. Volunteers who provide written informed consent to participate in this study and who are willing and able to perform frequent home spirometry monitoring and laboratory-based spirometry, per protocol.

Exclusion Criteria:

  1. Known cardiac or pulmonary condition, including any condition that may interfere with the subject's ability to perform pulmonary function testing either via home spirometry.
  2. Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
  3. Pregnant or planning to become pregnant during the study. Pregnant volunteers are excluded as changes in spirometry associated with a gravid uterus could alter outcome data. (Volunteers should take measures to prevent pregnancy while participating in the study.)
  4. Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance or inadequate English literacy/comprehension to operate the Home Spirometry System)
  5. Concomitant participation in another trial with an investigational device or investigational drug
  6. Volunteers who have a statistically significant rate of FEV1 decline that exceeds 30 mL/month using home spirometry based FEV1 values obtained during the normal range development period.

Information from the National Library of Medicine

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


Contacts
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Contact: Kathy Dodds, RN 314-747-0497 doddsk@wustl.edu
Contact: George Despotis, MD gjdespotis@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
Mallinckrodt
Investigators
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Principal Investigator: George Despotis, MD Washington University School of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03945500     History of Changes
Other Study ID Numbers: 201806011
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No