WearME-Pro Patch for COPD

(WearME-Pro Trial)

Not yet recruiting at 2 trial locations
LE
RN
Overseen ByRoland N Emokpae, Jr., MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: LASARRUS Clinic and Research Center
Must be taking: COPD maintenance therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

EC

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

Current, former, or never smoker (smoking history collected but not an eligibility requirement)
Able and willing to provide informed consent
Not currently enrolled in another investigational device study that could confound outcomes (prior WearME-Basic Phase I participation permitted if completed and not concurrent)
See 7 more

Exclusion Criteria

Any condition that, in the investigator's opinion, may interfere with compliance or safety
COPD exacerbation within past 6 weeks requiring systemic corticosteroids and/or antibiotics, urgent/ED visit, or hospitalization
Known allergy or severe skin sensitivity to medical adhesives, or dermatologic conditions at intended placement sites
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability Evaluation

Summative usability/human factors evaluation of the WearME-Pro patch, mobile app, and clinician dashboard

4 weeks
Baseline/Onboarding through Week 4

Longitudinal Home-Use Study

Participants use the WearME-Pro patch system for daily monitoring and comparison with handheld spirometry

10 months
Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: WearME-Pro Patch System + Guided TrainingExperimental Treatment3 Interventions
Group II: WearME-Pro Patch System (Self-Guided / No Training)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

LASARRUS Clinic and Research Center

Lead Sponsor

Trials
1
Recruited
130+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Tidalhealth

Collaborator

Trials
1
Recruited
130+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

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 ...

Effectiveness 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 ...

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 ...

6.

lasarrus.com

lasarrus.com/wearme

The Technology

The WearME physiological sensing system is paired with a mobile and desktop application to enable intuitive and accessible patient monitoring.