Mobile ApplicationsNCT03945500
Standardized Home Spirometry Method in Normal Population
A study testing Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter in people with Mobile Applications and Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mobile Applications, Healthy Volunteers, Feasibility Study
- What is being tested?
- Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age (18 years old or older)
- 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 if practicable, per protocol.
Who cannot join
- Known cardiac, pulmonary or other condition, that may interfere with the subject's ability to perform lab-based pulmonary function testing or standardized home spirometry.
- Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
- 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.)
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance, lack of WiFi and/or cellular access or inadequate English literacy/comprehension to operate the Home Spirometry System)
- Concomitant participation in another trial with an investigational device or investigational drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Assessment of a Standardized Home Spirometry Method for Frequent Monitoring of Lung Function in a Normal Population
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.
Read the detailed description
Study Objective: This study was designed to evaluate the feasibility of use of a Standardized Home Spirometry(SHS) Method using a Home Spirometry Monitoring Kit consisting of FDA-approved Blue-tooth Spirometry unit, Blue-tooth pulse oximeter and an Android-based Tablet with an embedded investigational home spirometry mobile medical software application for data and symptom survey collection and transmission over secure WiFi or cellular data transmission portal in HIPAA compliant fashion to an associated investigational IT dashboard application at the Central Monitoring Institute (CMI) Server at Washington University in St. Louis, 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 to the CMI in a small pilot of healthy volunteers prior to evaluation and use on a larger scale for lung transplant recipients.
The investigational IT application will monitor lung function but do nothing more than collect data. It will adjust monitoring frequency and trigger physician review of home spirometry results at a more frequent interval but will not be directly involved in decisions regarding diagnosis or treatment.
Study Type: Non-randomized, single-arm, prospective cohort study
Intervention:
- The Home Spirometry Monitoring System will consist of:
- FDA approved Blue tooth Spirometry unit
- FDA approved pulse oximeter
- An Android-based tablet with embedded investigational mobile medical software application for symptom survey/data collection and data processing and transmission
- WiFi or cellular connectivity to be used for data transmission and communication between an Android Pad and an associated Investigational server dashboard application at the Central Monitoring Institute
- Normal Volunteer Monitoring Data is sent in a HIPAA compliant fashion (data with date/time stamp and device ID only) to a Central Monitoring Institute (CMI) server maintained at Washington University in St. Louis
- Participants will undergo training to activate and use the Home Spirometry Monitoring System.
- Data evaluation by a pulmonologist within CMI:
- Trend analysis on a monthly basis and
- When a variance is detected with or without potentially associated symptoms.
- A monthly summary report
- Participants may undergo one Laboratory-based Spirometry Test (if practicable) and perform a test session using the standardized home spirometry method system at baseline.
- Participation may last up to one year.
Standardized Home Spirometry testing interval at least weekly with an initial testing period of greater frequency to enable normal range calibration. Volunteers will require initial in center or remote training with the Standardized home spirometry method \& performance of baseline home spirometry method testing and a (baseline) laboratory-based spirometry test (if practicable).
Pre-Surveillance Phase: Daily home spirometry method measurements for 4 to 10 weeks to enable normal range calibration. Volunteers who have either a statistically significant (p-value <0.01) rate of change in FEV1 or a change in FEV1 rate of decline that exceeds an absolute value (+/-) of 30 mL/month using home spirometry based FEV1 values obtained during the normal range development period are not eligible to advance to the Surveillance Phase and may be discontinued from the study.
Surveillance Phase: At least weekly home spirometry method measurements for two to ten months of participation. An FEV-1 (Forced Expiratory Volume in one second) variance is defined as an FEV-1 value that is outside the 95% CI (Confidence Interval) of the participant's normal FEV-1 reference range that was determined immediately after enrollment.
If an FEV-1 variance is detected by the Android Pad, the IT application automatically requests that the participant complete a symptom survey. This information when used in combination with other data will result in initiation of the following actions:
If an FEV-1 variance is categorized as being suspicious for acute medical illness by the CMI (i.e., with clinical symptoms consistent with upper or lower respiratory infection/CHF), the spirometry data and participant survey responses will trigger overview by the CMI laboratory staff and if deemed suspicious for acute medical illness results will be made accessible to the participant's designated health professionals. If critical values or clinical symptoms are obtained consistent with urgent compromise (e.g., evidence of hypoxemia or respiratory distress), the CMI (PFT (Pulmonary Function Testing) Laboratory staff pulmonologist) will make timely attempts to reach the participant or participant's health professionals. In this study, this is expected to be an exceedingly rare occurrence, and most likely would not occur at all. If acute medical illness has been ruled in, participant spirometry surveillance will be reinitiated after an appropriate period of treatment, which will be determined by the participant's managing physician who will notify CMI when the participant has recovered from their acute illness.
Variance not suspicious for acute medical illness with no apparent clinical symptoms consistent with infection/CHF: if supplemental questionnaire or clinical data is not consistent with an acute medical illness, the following actions will be taken:
Persistence Evaluation: Participants will be directed to obtain daily spirometric measurements along with repeated completion of the questionnaire for a total of 4 consecutive days CMI Pulmonology Review: Consistently low Spirometry values (persistence) will prompt early review of these values along with previous Spirometry history by CMI pulmonology staff.
Random Symptom Surveys may also generate (in the absence of a variance) however only Symptom Surveys prompted by Variances will result in further action as described above.
During the first two months (approximately) of Surveillance, Volunteers will be directed to intentionally induce variances, symptoms, incomplete connections/testing/survey, etc., in order to fully test and assess the functionality of the Mobile Medical Software neural pathways (IT app and Dashboard server) as directed by the study team. Volunteers will document test on a test log.
The FDA issued a non-significant risk (NSR) device study letter on 12/3/2018 for the Home Spirometry Mobile Medical Software.
- Conditions
- Mobile Applications, Healthy Volunteers, Feasibility Study
- Being tested
- Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeterDevice
Also called Baseline Laboratory Spirometry Testing
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Home Spirometry (SHS) Method | Experimental | The Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded in an Android Tablet \& FDA approved spirometer \& pulse oximeter.
Participants will be trained with the SHS method, perform an initial home spirometry test session \& a lab-based spirometry test (if practicable).
Pre-surveillance Phase:Daily SHS Testing for 4 to 10 weeks to enable the Mobile Medical application to generate volunteer specific normal range.
Surveillance Phase: At least weekly SHS Testing. During approximately two months of the surveillance phase, the volunteer will test one to four times per week to assess the SHS neural pathways as directed by the study team. Test sessions will be documented on a test log. Subjects may be asked to perform additional SHS pathway test logs, continue at least weekly testing, pause testing or end participation following completion of the initial SHS neural pathway test log. Receives: Device: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Assess Home Spirometry reproducibility during pre-surveillance period.
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.
Measured: Up to 8 weeks
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Drift Assessment
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.
Measured: Up to 8 weeks
Feasibility of using the Standardized Home Spirometry (SHS) Method and associated IT Dashboard Server: Pathway Verification
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).
Measured: Through study completion, up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start20 Jan 2021
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Mobile ApplicationsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Evaluate the feasibility of using a Standardized Home Spirometry Method and associated investigational Home Spirometry Mobile Medical Software (IT App) and Server "Dashboard" in a healthy volunteer population before beginning a separate full clinical trial in the lung transplant population. Feasibility of using the 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 will be evaluated.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- George Despotis, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945500
- Sponsor's protocol ID
- 201806011
- Status last verified
- Dec 2022
- First submitted
- 1 May 2019
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yusen RD, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Lund LH, Meiser B, Stehlik J; International Society for Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):1009-24. doi: 10.1016/j.healun.2014.08.004. Epub 2014 Aug 14. No abstract available.
PubMed 25242125Meyer KC, Raghu G, Verleden GM, Corris PA, Aurora P, Wilson KC, Brozek J, Glanville AR; ISHLT/ATS/ERS BOS Task Force Committee; ISHLT/ATS/ERS BOS Task Force Committee. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014 Dec;44(6):1479-503. doi: 10.1183/09031936.00107514. Epub 2014 Oct 30.
PubMed 25359357Kapila A, Baz MA, Valentine VG, Bhorade SM; AIRSAC investigators. Reliability of diagnostic criteria for bronchiolitis obliterans syndrome after lung transplantation: a survey. J Heart Lung Transplant. 2015 Jan;34(1):65-74. doi: 10.1016/j.healun.2014.09.029. Epub 2014 Oct 7.
PubMed 25447585Slovis BS, Loyd JE, King LE Jr. Photopheresis for chronic rejection of lung allografts. N Engl J Med. 1995 Apr 6;332(14):962. doi: 10.1056/NEJM199504063321417. No abstract available.
PubMed 7877665O'Hagan AR, Stillwell PC, Arroliga A, Koo A. Photopheresis in the treatment of refractory bronchiolitis obliterans complicating lung transplantation. Chest. 1999 May;115(5):1459-62. doi: 10.1378/chest.115.5.1459.
PubMed 10334173Salerno CT, Park SJ, Kreykes NS, Kulick DM, Savik K, Hertz MI, Bolman RM 3rd. Adjuvant treatment of refractory lung transplant rejection with extracorporeal photopheresis. J Thorac Cardiovasc Surg. 1999 Jun;117(6):1063-9. doi: 10.1016/s0022-5223(99)70241-2.
PubMed 10343253Villanueva J, Bhorade SM, Robinson JA, Husain AN, Garrity ER Jr. Extracorporeal photopheresis for the treatment of lung allograft rejection. Ann Transplant. 2000;5(3):44-7.
PubMed 11233043Benden C, Speich R, Hofbauer GF, Irani S, Eich-Wanger C, Russi EW, Weder W, Boehler A. Extracorporeal photopheresis after lung transplantation: a 10-year single-center experience. Transplantation. 2008 Dec 15;86(11):1625-7. doi: 10.1097/TP.0b013e31818bc024.
PubMed 19077900Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR. The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.
PubMed 19853479Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.
PubMed 22884382Greer M, Dierich M, De Wall C, Suhling H, Rademacher J, Welte T, Haverich A, Warnecke G, Ivanyi P, Buchholz S, Gottlieb J, Fuehner T. Phenotyping established chronic lung allograft dysfunction predicts extracorporeal photopheresis response in lung transplant patients. Am J Transplant. 2013 Apr;13(4):911-918. doi: 10.1111/ajt.12155. Epub 2013 Feb 13.
PubMed 23406373Del Fante C, Scudeller L, Oggionni T, Viarengo G, Cemmi F, Morosini M, Cascina A, Meloni F, Perotti C. Long-Term Off-Line Extracorporeal Photochemotherapy in Patients with Chronic Lung Allograft Rejection Not Responsive to Conventional Treatment: A 10-Year Single-Centre Analysis. Respiration. 2015;90(2):118-28. doi: 10.1159/000431382. Epub 2015 Jun 20.
PubMed 26112178Liistro G, Vanwelde C, Vincken W, Vandevoorde J, Verleden G, Buffels J; COPD Advisory Board. Technical and functional assessment of 10 office spirometers: A multicenter comparative study. Chest. 2006 Sep;130(3):657-65. doi: 10.1378/chest.130.3.657.
PubMed 16963659Lefebvre Q, Vandergoten T, Derom E, Marchandise E, Liistro G. Testing spirometers: are the standard curves of the american thoracic society sufficient? Respir Care. 2014 Dec;59(12):1895-904. doi: 10.4187/respcare.02918. Epub 2014 Sep 2.
PubMed 25185146
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Standardized Home Spirometry Method for Frequent Monitoring of Lung Function in a Normal Population
- ClinicalTrials.gov ID
- NCT03945500
- Acronym / sponsor ID
- 201806011
- Conditions
- Mobile Applications, Healthy Volunteers, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objective: This study was designed to evaluate the feasibility of use of a Standardized Home Spirometry(SHS) Method using a Home Spirometry Monitoring Kit consisting of FDA-approved Blue-tooth Spirometry unit, Blue-tooth pulse oximeter and an Android-based Tablet with an embedded investigational home spirometry mobile medical software application for data and symptom survey collection and transmission over secure WiFi or cellular data transmission portal in HIPAA compliant fashion to an associated investigational IT dashboard application at the Central Monitoring Institute (CMI) Server at Washington University in St. Louis, 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 to the CMI in a small pilot of healthy volunteers prior to evaluation and use on a larger scale for lung transplant recipients.
The investigational IT application will monitor lung function but do nothing more than collect data. It will adjust monitoring frequency and trigger physician review of home spirometry results at a more frequent interval but will not be directly involved in decisions regarding diagnosis or treatment.
Study Type: Non-randomized, single-arm, prospective cohort study
Intervention:
- The Home Spirometry Monitoring System will consist of:
- FDA approved Blue tooth Spirometry unit
- FDA approved pulse oximeter
- An Android-based tablet with embedded investigational mobile medical software application for symptom survey/data collection and data processing and transmission
- WiFi or cellular connectivity to be used for data transmission and communication between an Android Pad and an associated Investigational server dashboard application at the Central Monitoring Institute
- Normal Volunteer Monitoring Data is sent in a HIPAA compliant fashion (data with date/time stamp and device ID only) to a Central Monitoring Institute (CMI) server maintained at Washington University in St. Louis
- Participants will undergo training to activate and use the Home Spirometry Monitoring System.
- Data evaluation by a pulmonologist within CMI:
- Trend analysis on a monthly basis and
- When a variance is detected with or without potentially associated symptoms.
- A monthly summary report
- Participants may undergo one Laboratory-based Spirometry Test (if practicable) and perform a test session using the standardized home spirometry method system at baseline.
- Participation may last up to one year.
Standardized Home Spirometry testing interval at least weekly with an initial testing period of greater frequency to enable normal range calibration. Volunteers will require initial in center or remote training with the Standardized home spirometry method \& performance of baseline home spirometry method testing and a (baseline) laboratory-based spirometry test (if practicable).
Pre-Surveillance Phase: Daily home spirometry method measurements for 4 to 10 weeks to enable normal range calibration. Volunteers who have either a statistically significant (p-value <0.01) rate of change in FEV1 or a change in FEV1 rate of decline that exceeds an absolute value (+/-) of 30 mL/month using home spirometry based FEV1 values obtained during the normal range development period are not eligible to advance to the Surveillance Phase and may be discontinued from the study.
Surveillance Phase: At least weekly home spirometry method measurements for two to ten months of participation. An FEV-1 (Forced Expiratory Volume in one second) variance is defined as an FEV-1 value that is outside the 95% CI (Confidence Interval) of the participant's normal FEV-1 reference range that was determined immediately after enrollment.
If an FEV-1 variance is detected by the Android Pad, the IT application automatically requests that the participant complete a symptom survey. This information when used in combination with other data will result in initiation of the following actions:
If an FEV-1 variance is categorized as being suspicious for acute medical illness by the CMI (i.e., with clinical symptoms consistent with upper or lower respiratory infection/CHF), the spirometry data and participant survey responses will trigger overview by the CMI laboratory staff and if deemed suspicious for acute medical illness results will be made accessible to the participant's designated health professionals. If critical values or clinical symptoms are obtained consistent with urgent compromise (e.g., evidence of hypoxemia or respiratory distress), the CMI (PFT (Pulmonary Function Testing) Laboratory staff pulmonologist) will make timely attempts to reach the participant or participant's health professionals. In this study, this is expected to be an exceedingly rare occurrence, and most likely would not occur at all. If acute medical illness has been ruled in, participant spirometry surveillance will be reinitiated after an appropriate period of treatment, which will be determined by the participant's managing physician who will notify CMI when the participant has recovered from their acute illness.
Variance not suspicious for acute medical illness with no apparent clinical symptoms consistent with infection/CHF: if supplemental questionnaire or clinical data is not consistent with an acute medical illness, the following actions will be taken:
Persistence Evaluation: Participants will be directed to obtain daily spirometric measurements along with repeated completion of the questionnaire for a total of 4 consecutive days CMI Pulmonology Review: Consistently low Spirometry values (persistence) will prompt early review of these values along with previous Spirometry history by CMI pulmonology staff.
Random Symptom Surveys may also generate (in the absence of a variance) however only Symptom Surveys prompted by Variances will result in further action as described above.
During the first two months (approximately) of Surveillance, Volunteers will be directed to intentionally induce variances, symptoms, incomplete connections/testing/survey, etc., in order to fully test and assess the functionality of the Mobile Medical Software neural pathways (IT app and Dashboard server) as directed by the study team. Volunteers will document test on a test log.
The FDA issued a non-significant risk (NSR) device study letter on 12/3/2018 for the Home Spirometry Mobile Medical Software.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluate the feasibility of using a Standardized Home Spirometry Method and associated investigational Home Spirometry Mobile Medical Software (IT App) and Server "Dashboard" in a healthy volunteer population before beginning a separate full clinical trial in the lung transplant population. Feasibility of using the 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 will be evaluated.
| Arm | Type | Receives |
|---|---|---|
| Standardized Home Spirometry (SHS) Method | Experimental | Device: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeterThe Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded in an Android Tablet \& FDA approved spirometer \& pulse oximeter. Participants will be trained with the SHS method, perform an initial home spirometry test session \& a lab-based spirometry test (if practicable). Pre-surveillance Phase:Daily SHS Testing for 4 to 10 weeks to enable the Mobile Medical application to generate volunteer specific normal range. Surveillance Phase: At least weekly SHS Testing. During approximately two months of the surveillance phase, the volunteer will test one to four times per week to assess the SHS neural pathways as directed by the study team. Test sessions will be documented on a test log. Subjects may be asked to perform additional SHS pathway test logs, continue at least weekly testing, pause testing or end participation following completion of the initial SHS neural pathway test log. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age (18 years old or older)
- 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 if practicable, per protocol.
Key exclusion criteria (5 listed)
- Known cardiac, pulmonary or other condition, that may interfere with the subject's ability to perform lab-based pulmonary function testing or standardized home spirometry.
- Any condition that would significantly affect the participant's ability to adhere to the protocol, or affect interpretation of the study results.
- 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.)
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance, lack of WiFi and/or cellular access or inadequate English literacy/comprehension to operate the Home Spirometry System)
- Concomitant participation in another trial with an investigational device or investigational drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeterAlso: Baseline Laboratory Spirometry TestingStandardized 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. | Device | Standardized Home Spirometry (SHS) Method |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Background: PubMed 25242125Yusen RD, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Lund LH, Meiser B, Stehlik J; International Society for Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):1009-24. doi: 10.1016/j.healun.2014.08.004. Epub 2014 Aug 14. No abstract available.
- Background: PubMed 25359357Meyer KC, Raghu G, Verleden GM, Corris PA, Aurora P, Wilson KC, Brozek J, Glanville AR; ISHLT/ATS/ERS BOS Task Force Committee; ISHLT/ATS/ERS BOS Task Force Committee. An international ISHLT/ATS/ERS clinical practice guideline: diagnosis and management of bronchiolitis obliterans syndrome. Eur Respir J. 2014 Dec;44(6):1479-503. doi: 10.1183/09031936.00107514. Epub 2014 Oct 30.
- Background: PubMed 25447585Kapila A, Baz MA, Valentine VG, Bhorade SM; AIRSAC investigators. Reliability of diagnostic criteria for bronchiolitis obliterans syndrome after lung transplantation: a survey. J Heart Lung Transplant. 2015 Jan;34(1):65-74. doi: 10.1016/j.healun.2014.09.029. Epub 2014 Oct 7.
- Background: PubMed 7877665Slovis BS, Loyd JE, King LE Jr. Photopheresis for chronic rejection of lung allografts. N Engl J Med. 1995 Apr 6;332(14):962. doi: 10.1056/NEJM199504063321417. No abstract available.
- Background: PubMed 10334173O'Hagan AR, Stillwell PC, Arroliga A, Koo A. Photopheresis in the treatment of refractory bronchiolitis obliterans complicating lung transplantation. Chest. 1999 May;115(5):1459-62. doi: 10.1378/chest.115.5.1459.
- Background: PubMed 10343253Salerno CT, Park SJ, Kreykes NS, Kulick DM, Savik K, Hertz MI, Bolman RM 3rd. Adjuvant treatment of refractory lung transplant rejection with extracorporeal photopheresis. J Thorac Cardiovasc Surg. 1999 Jun;117(6):1063-9. doi: 10.1016/s0022-5223(99)70241-2.
- Background: PubMed 11233043Villanueva J, Bhorade SM, Robinson JA, Husain AN, Garrity ER Jr. Extracorporeal photopheresis for the treatment of lung allograft rejection. Ann Transplant. 2000;5(3):44-7.
- Background: PubMed 19077900Benden C, Speich R, Hofbauer GF, Irani S, Eich-Wanger C, Russi EW, Weder W, Boehler A. Extracorporeal photopheresis after lung transplantation: a 10-year single-center experience. Transplantation. 2008 Dec 15;86(11):1625-7. doi: 10.1097/TP.0b013e31818bc024.
- Background: PubMed 19853479Morrell MR, Despotis GJ, Lublin DM, Patterson GA, Trulock EP, Hachem RR. The efficacy of photopheresis for bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2010 Apr;29(4):424-31. doi: 10.1016/j.healun.2009.08.029. Epub 2009 Oct 22.
- Background: PubMed 22884382Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.
- Background: PubMed 23406373Greer M, Dierich M, De Wall C, Suhling H, Rademacher J, Welte T, Haverich A, Warnecke G, Ivanyi P, Buchholz S, Gottlieb J, Fuehner T. Phenotyping established chronic lung allograft dysfunction predicts extracorporeal photopheresis response in lung transplant patients. Am J Transplant. 2013 Apr;13(4):911-918. doi: 10.1111/ajt.12155. Epub 2013 Feb 13.
- Background: PubMed 26112178Del Fante C, Scudeller L, Oggionni T, Viarengo G, Cemmi F, Morosini M, Cascina A, Meloni F, Perotti C. Long-Term Off-Line Extracorporeal Photochemotherapy in Patients with Chronic Lung Allograft Rejection Not Responsive to Conventional Treatment: A 10-Year Single-Centre Analysis. Respiration. 2015;90(2):118-28. doi: 10.1159/000431382. Epub 2015 Jun 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Despotis, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter in people with Mobile Applications and Healthy Volunteers, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945500, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.