Chronic Obstructive Pulmonary Disease (COPD)WearME-COPDNCT06751537
Effectiveness of the WearME System for COPD Severity and Respiratory Function
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by LASARRUS Clinic and Research Center at 2 sites in United States.
Trial summary
This observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing its measurements to standard spirometry, capnography, and other clinical assessments in 128 COPD participants. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 128 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult COPD patients recruited from outpatient clinics at LASARRUS, Johns Hopkins, and TidalHealth.
Who may be able to join
- Adult participants aged 21-100 years, of any sex, and of any race/ethnicity, who are able to understand and sign consent documents in English or Spanish.
- Diagnosed with COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria [5] , with the following severity levels (confirmed via spirometry performed after consent):
- Mild: FEV1/FVC < 0.7 and FEV1 ≥ 80%
- Moderate: FEV1/FVC < 0.7 and 50% ≤ FEV1 < 80%
- Severe: FEV1/FVC < 0.7 and 30% ≤ FEV1 < 50%
- Very Severe: FEV1/FVC < 0.7 and FEV1 < 30% or FEV1 < 50%, plus chronic respiratory failure.
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- Note: Participants will be consented and enrolled based on prior diagnosis of COPD from medical records within the past year to confirm eligibility and stratify COPD severity levels. Spirometry will be performed during concurrent data collection with the WearME device for comparison. Screening failures are expected and will be recorded and managed appropriately.
- Current, former, or never smoker; any amount of time between quitting and study enrollment is allowed).
- Ability to understand and willingness to sign consent documents.
- Able to participate in study procedures as required.
Who cannot join
- Participants with known skin allergies or conditions that may interfere with device application or signal transmission.
- Currently receiving invasive mechanical ventilation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21224
Chathurangi Pathiravasan, PhD, 617-416-6222, cpathir1@jh.edu
Adrian S Dobs, MD, 443-604-3745, adobs@jhmi.edu
- Recruiting
TidalHealth
Salisbury, Maryland, 21801
Robert L Joyner, PhD, 410-543-7017, Robert.Joyner@tidalhealth.org
Sandra Fetko, MSN, 410-912-6045, Sandra.Fetko@tidalhealth.org
About this study
Official title: Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients
This observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing its measurements to standard spirometry, capnography, and other clinical assessments in 128 COPD participants.
Read the detailed description
COPD is the third leading cause of death worldwide, with over 3 million deaths and an estimated total cost of $52 billion in the U.S. alone. This project, in collaboration with the Johns Hopkins Clinical Research Network (JHCRN), aims to provide technological innovation access to underserved patients in low-income, rural, and diverse ethnicities in the Mid-Atlantic region.
The symptoms of COPD include dyspnea (shortness of breath), coughing and the production of sputum. Recent data shows that the 30-day readmission rate of COPD patients is approaching 23%, creating a huge burden on the health care system. Exacerbations can commonly be treated in the home if detected early, so early recognition of symptoms signaling an impending COPD exacerbation may reduce readmission and associated healthcare costs. The standard adjuncts used to assess lung function (e.g., spirometry, plethysmography, CT scan) require oversight by medical experts, are time consuming, and do not allow for continuous and remote patient monitoring of an acute exacerbation. Early recognition of deteriorating patient's lung function will enable timely intervention and help manage changes in COPD severity.
- EFFECTIVENESS STUDY OVERVIEW
In this study, the WearME-Basic functionality will be validated while using the same hardware needed for the WearME-Basic app. Since the hardware collects all data needed to supply either the Basic or Pro app, the investigators will also gain insights on both the Basic and Pro simultaneously during this study.
This study will assess the effectiveness of the WearME-Pro system in monitoring COPD patients by measuring the accuracy and reliability of the system for forced expiratory volume (FEV₁), forced vital capacity (FVC), respiratory rate, heart rate, I:E ratio, spinal range of motion (ROM), and activity levels. Up to 128 COPD participants will be recruited from the LASARRUS outpatient clinic, Johns Hopkins and TidalHealth hospitals, and stratified into four groups based on the GOLD standard for severity stratification. Participants will be asked to wear the WearME system during a data collection period of 145 minutes.
The primary outcome measure will be the Bland-Altman LOA between the FEV1/FVC measurements of WearME-Pro FEV1/FVC prediction (recorded within the WearME-Basic app but not displayed to users) and the gold standard devices. Secondary outcomes include the validation of the WearME-Basic system for FDA submission by evaluating its accuracy in measuring respiration rate, heart rate, I:E ratio, and ROM compared to gold standard reference devices, and correlation of I:E measured by the WearME device to FEV1/FVC measured by spirometry.
We will use standard medical devices as reference devices for comparison with the WearME systems outputs. The specific devices used for spirometry, capnography, heart rate monitoring, and range of motion measurement will be appropriate, FDA-cleared devices commonly used in clinical practice.
Details of the specific device models and their usage will be documented in the Manual of Procedures (MOP). The sponsor will provide all necessary reference devices to the study sites, including the spirometers, capnographs, and other equipment required for the study.
- Keywords
- lung function, respiratory rate, FEV1, FVC, I:E ratio, Pulmonary Devices, Machine Learning
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD Participants | Participants are wearing the WearME device and undergoing reference testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between WearME-Pro system and gold standard devices for FEV1 measurements, stratified by COPD severity.
The primary outcome measure will be the Bland-Altman LOA between the FEV1/FVC measurements of WearME-Pro FEV1/FVC prediction (recorded within the WearME-Basic app but not displayed to users) and the gold standard devices.
Measured: Within 6 months of study start.
Secondary outcomes (4)
Accuracy of WearME-Basic in measuring Respiration Rate
Accuracy of WearME-Basic in measuring Respiration Rate
Measured: Within 6 months of study start.
Accuracy of WearME-Basic in measuring I:E ratio
Accuracy of WearME-Basic in measuring I:E ratio
Measured: Within 6 months of study start.
Accuracy of WearME-Basic in measuring Heart Rate
Accuracy of WearME-Basic in measuring Heart Rate
Measured: Within 6 months of study start.
Accuracy of WearME-Basic in measuring ROM
Accuracy of WearME-Basic in measuring ROM
Measured: Within 6 months of study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start29 May 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LASARRUS Clinic and Research Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins University, Tidalhealth, TidalHealth, Inc., Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751537
- Sponsor's protocol ID
- LAS-01-WZ-023
- Other IDs
- 1R44HL172444-01A1
- Acronym
- WearME-COPD
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Types: Scientific Data to be Shared: 1. Clinical Data: * De-identified patient demographics (age, sex, ethnicity) * Clinical assessments and outcomes * Pulmonary function test results (e.g., FEV1, FVC ratios) * Respiratory rate (RR), Inspiratory/Expiratory (I:E) ratio, activity measurements 2. Physiological Measurements: * Bilateral acoustic recordings from the WearME-Pro device * Kinematic data (accelerometer, gyroscope readings) * Temperature measurements 3. Machine Learning Outputs: * Model parameters and outputs from the AUDAS algorithm * Processed data used for developing predictive models Data Sharing and Access: 1\. Repository Selection: Upon completion of the project, de-identified datasets and associated metadata will be deposited in Figshare, a widely used, NIH-compliant public repository that provides persistent identifiers (DOIs) and facilitates open access.
Publications
Nicholson PJ. The updated ATS/ERS spirometry technical standards. Occup Med (Lond). 2020 May 27;70(3):146-148. doi: 10.1093/occmed/kqaa030. No abstract available.
PubMed 32073625Lokke A, Lange P, Lykkegaard J, Ibsen R, Andersson M, de Fine Licht S, Hilberg O. Economic Burden of COPD by Disease Severity - A Nationwide Cohort Study in Denmark. Int J Chron Obstruct Pulmon Dis. 2021 Mar 10;16:603-613. doi: 10.2147/COPD.S295388. eCollection 2021.
PubMed 33731990GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
PubMed 32526187
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients
- ClinicalTrials.gov ID
- NCT06751537
- Acronym / sponsor ID
- WearME-COPD / LAS-01-WZ-023
- Keywords
- lung function, respiratory rate, FEV1, FVC, I:E ratio, Pulmonary Devices, Machine Learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- LASARRUS Clinic and Research CenterIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Johns Hopkins University, Tidalhealth, TidalHealth, Inc., Johns Hopkins Bloomberg School of Public Health
- Study start
- 29 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Dec 2024 (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 observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing its measurements to standard spirometry, capnography, and other clinical assessments in 128 COPD participants.
Detailed description
COPD is the third leading cause of death worldwide, with over 3 million deaths and an estimated total cost of $52 billion in the U.S. alone. This project, in collaboration with the Johns Hopkins Clinical Research Network (JHCRN), aims to provide technological innovation access to underserved patients in low-income, rural, and diverse ethnicities in the Mid-Atlantic region.
The symptoms of COPD include dyspnea (shortness of breath), coughing and the production of sputum. Recent data shows that the 30-day readmission rate of COPD patients is approaching 23%, creating a huge burden on the health care system. Exacerbations can commonly be treated in the home if detected early, so early recognition of symptoms signaling an impending COPD exacerbation may reduce readmission and associated healthcare costs. The standard adjuncts used to assess lung function (e.g., spirometry, plethysmography, CT scan) require oversight by medical experts, are time consuming, and do not allow for continuous and remote patient monitoring of an acute exacerbation. Early recognition of deteriorating patient's lung function will enable timely intervention and help manage changes in COPD severity.
- EFFECTIVENESS STUDY OVERVIEW
In this study, the WearME-Basic functionality will be validated while using the same hardware needed for the WearME-Basic app. Since the hardware collects all data needed to supply either the Basic or Pro app, the investigators will also gain insights on both the Basic and Pro simultaneously during this study.
This study will assess the effectiveness of the WearME-Pro system in monitoring COPD patients by measuring the accuracy and reliability of the system for forced expiratory volume (FEV₁), forced vital capacity (FVC), respiratory rate, heart rate, I:E ratio, spinal range of motion (ROM), and activity levels. Up to 128 COPD participants will be recruited from the LASARRUS outpatient clinic, Johns Hopkins and TidalHealth hospitals, and stratified into four groups based on the GOLD standard for severity stratification. Participants will be asked to wear the WearME system during a data collection period of 145 minutes.
The primary outcome measure will be the Bland-Altman LOA between the FEV1/FVC measurements of WearME-Pro FEV1/FVC prediction (recorded within the WearME-Basic app but not displayed to users) and the gold standard devices. Secondary outcomes include the validation of the WearME-Basic system for FDA submission by evaluating its accuracy in measuring respiration rate, heart rate, I:E ratio, and ROM compared to gold standard reference devices, and correlation of I:E measured by the WearME device to FEV1/FVC measured by spirometry.
We will use standard medical devices as reference devices for comparison with the WearME systems outputs. The specific devices used for spirometry, capnography, heart rate monitoring, and range of motion measurement will be appropriate, FDA-cleared devices commonly used in clinical practice.
Details of the specific device models and their usage will be documented in the Manual of Procedures (MOP). The sponsor will provide all necessary reference devices to the study sites, including the spirometers, capnographs, and other equipment required for the study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Participants | – | –Participants are wearing the WearME device and undergoing reference testing |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult COPD patients recruited from outpatient clinics at LASARRUS, Johns Hopkins, and TidalHealth.
Key inclusion criteria (10 listed)
- Adult participants aged 21-100 years, of any sex, and of any race/ethnicity, who are able to understand and sign consent documents in English or Spanish.
- Diagnosed with COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria [5] , with the following severity levels (confirmed via spirometry performed after consent):
- Note: Participants will be consented and enrolled based on prior diagnosis of COPD from medical records within the past year to confirm eligibility and stratify COPD severity levels. Spirometry will be performed during concurrent data collection with the WearME device for comparison. Screening failures are expected and will be recorded and managed appropriately.
- Current, former, or never smoker; any amount of time between quitting and study enrollment is allowed).
- Ability to understand and willingness to sign consent documents.
Key exclusion criteria (2 listed)
- Participants with known skin allergies or conditions that may interfere with device application or signal transmission.
- Currently receiving invasive mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between WearME-Pro system and gold standard devices for FEV1 measurements, stratified by COPD severity.
Time frame: Within 6 months of study start.
The primary outcome measure will be the Bland-Altman LOA between the FEV1/FVC measurements of WearME-Pro FEV1/FVC prediction (recorded within the WearME-Basic app but not displayed to users) and the gold standard devices.
4 secondary outcomes
Accuracy of WearME-Basic in measuring Respiration Rate
Time frame: Within 6 months of study start.
Accuracy of WearME-Basic in measuring I:E ratio
Time frame: Within 6 months of study start.
Accuracy of WearME-Basic in measuring Heart Rate
Time frame: Within 6 months of study start.
Accuracy of WearME-Basic in measuring ROM
Time frame: Within 6 months of study start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Results publication: PubMed 32073625Nicholson PJ. The updated ATS/ERS spirometry technical standards. Occup Med (Lond). 2020 May 27;70(3):146-148. doi: 10.1093/occmed/kqaa030. No abstract available.
- Results publication: PubMed 33731990Lokke A, Lange P, Lykkegaard J, Ibsen R, Andersson M, de Fine Licht S, Hilberg O. Economic Burden of COPD by Disease Severity - A Nationwide Cohort Study in Denmark. Int J Chron Obstruct Pulmon Dis. 2021 Mar 10;16:603-613. doi: 10.2147/COPD.S295388. eCollection 2021.
- Results publication: PubMed 32526187GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.
- Individual participant dataSharing planned: Yes. Data Types: Scientific Data to be Shared: 1. Clinical Data: * De-identified patient demographics (age, sex, ethnicity) * Clinical assessments and outcomes * Pulmonary function test results (e.g., FEV1, FVC ratios) * Respiratory rate (RR), Inspiratory/Expiratory (I:E) ratio, activity measurements 2. Physiological Measurements: * Bilateral acoustic recordings from the WearME-Pro device * Kinematic data (accelerometer, gyroscope readings) * Temperature measurements 3. Machine Learning Outputs: * Model parameters and outputs from the AUDAS algorithm * Processed data used for developing predictive models Data Sharing and Access: 1. Repository Selection: Upon completion of the project, de-identified datasets and associated metadata will be deposited in Figshare, a widely used, NIH-compliant public repository that provides persistent identifiers (DOIs) and facilitates open access.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by LASARRUS Clinic and Research Center at 2 sites 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 10 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lloyd E Emokpae, PhD. (301-388-5453, lloyd.emokpae@lasarrus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between WearME-Pro system and gold standard devices for FEV1 measurements, stratified by COPD severity. (time frame: Within 6 months of study start.). 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 NCT06751537, which also lists 3 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 9 Sep 2025.