WearME-Pro Patch for COPD
(WearME-Pro Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new wearable patch system designed to help people with COPD monitor their lung function at home. The goal is to assess the safety and ease of use of the WearME-Pro Patch System and its effectiveness in tracking lung health compared to a handheld device. Participants will use the patch with either guided training or self-guided instructions. This trial suits those who have managed COPD for at least two months without changing their medication and can perform daily tasks like sitting upright and using a simple device. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance COPD management for many.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you need to stop taking your current medications. However, you must be on stable maintenance therapy for at least 2 months without changes in medication class or dose.
What prior data suggests that the WearME-Pro patch system is safe for monitoring COPD?
Previous studies have tested the WearME-Pro patch system for safety and ease of use in monitoring adults with COPD, a lung disease that makes breathing difficult. Research has shown that the device is generally well-tolerated, with no major side effects reported. The patch system includes wearable technology that tracks breathing and lung function. It has monitored the severity of COPD and respiratory health, showing promising results without safety concerns. Although the patch remains under study, these findings suggest it is safe for home use.12345
Why are researchers excited about this trial?
Researchers are excited about the WearME-Pro Patch for COPD because it offers a novel approach to monitoring lung function at home. Unlike traditional COPD treatments that primarily involve inhalers and medications to manage symptoms, this patch system provides a non-invasive way to continuously assess lung health. Participants use the patch alongside daily handheld spirometry, potentially leading to better adherence and a more comprehensive understanding of disease management. By evaluating usability and predictive accuracy, this trial aims to find out if the patch can effectively complement existing therapies and improve patient outcomes.
What evidence suggests that the WearME-Pro patch system is effective for monitoring COPD?
Research has shown that the WearME-Pro patch system holds promise for monitoring COPD (chronic obstructive pulmonary disease) at home. In this trial, participants will use the WearME-Pro patch system in one of two ways: with guided training or through self-guided instructions. Studies have found that the system effectively tracks breathing by comparing its data to standard lung function tests. Early results suggest that the system can accurately detect breathing patterns and changes, such as wheezing, using advanced technology. Additionally, the Mayo Clinic found that data from the wearable device could predict patients' likelihood of participating in remote rehab programs for COPD. These findings highlight the potential of the WearME-Pro patch to aid in the ongoing monitoring and management of COPD.12346
Who Is on the Research Team?
Edward Chen, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for adults aged 21 or older diagnosed with COPD who can use a smartphone or tablet, are on stable treatment, and can perform daily breathing tests. People can't join if they've had a recent COPD flare-up, have skin allergies to adhesives, or can't follow the study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Usability Evaluation
Summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard
Longitudinal Home-Use Study
Participants use the WearME-Pro patch system for daily monitoring and comparison with handheld spirometry
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- WearME-Pro Patch System
Trial Overview
The study is testing the WearME-Pro patch system for remote monitoring of lung function in people with COPD at home. It compares results from this wearable device to those from an FDA-approved handheld spirometer over about 11 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants receive guided onboarding/training on device setup, app workflow, and patch placement. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.
Participants with COPD use the WearME-Pro patch system at home and complete scheduled sessions plus daily handheld spirometry. Participants follow self-guided instructions without guided training. Usability, adherence, and agreement between WearME-Pro predicted lung function and reference spirometry are evaluated. WearME-Pro outputs are investigational and not used for clinical decision-making.
Find a Clinic Near You
Who Is Running the Clinical Trial?
LASARRUS Clinic and Research Center
Lead Sponsor
Johns Hopkins University
Collaborator
Tidalhealth
Collaborator
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
WearME-Pro Phase II: Remote Use Usability and ...
This Phase II investigation evaluates the safety, usability, and clinical performance of the WearME-Pro patch system for remote monitoring of adults with ...
Effectiveness of the WearME System for COPD Severity ...
This observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing its ...
A wearable multi-modal acoustic system for breathing analysis
The results are shown from data collected from over 35 healthy subjects and 3 COPD subjects, demonstrating a positive correlation of SNR values ...
4.
ctv.veeva.com
ctv.veeva.com/study/effectiveness-of-the-wearme-system-for-copd-severity-and-respiratory-functionEffectiveness of the WearME System for COPD Severity and ...
This observational study evaluates the effectiveness of the WearME system in monitoring COPD severity and respiratory function by comparing ...
5.
newsnetwork.mayoclinic.org
newsnetwork.mayoclinic.org/discussion/mayo-clinic-study-finds-wearable-data-may-help-predict-patient-engagement-in-remote-copd-rehabilitation/Mayo Clinic study finds wearable data may help predict ...
Mayo Clinic research shows wearable sleep data can help predict COPD patients' engagement in remote pulmonary rehab, enabling more ...
The Technology
The WearME physiological sensing system is paired with a mobile and desktop application to enable intuitive and accessible patient monitoring.
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