RECRUITING

Effectiveness of the WearME System for COPD Severity and Respiratory Function

Conditions

Chronic Obstructive Pulmonary Disease (COPD)lung function respiratory rate FEV1 FVC I:E ratio Pulmonary Devices Machine Learning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effectiveness of WearME System for FEV1/FVC, Respiration and Activity Biomarkers in COPD Patients

Quick Facts

Study Start:2025-05-29

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06751537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* Participants with known skin allergies or conditions that may interfere with device application or signal transmission. * Currently receiving invasive mechanical ventilation.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* Participants with known skin allergies or conditions that may interfere with device application or signal transmission.
* Currently receiving invasive mechanical ventilation.

Contacts and Locations

Study Contact

Lloyd E Emokpae, PhD.

CONTACT

301-388-5453

lloyd.emokpae@lasarrus.com

Roland N Emokpae, MD

CONTACT

301-388-8067

roland.emokpae.jr@lasarrus.com

Study Locations (Sites)

Johns Hopkins

Baltimore, Maryland, 21224

United States

TidalHealth

Salisbury, Maryland, 21801

United States

Collaborators and Investigators

Sponsor: LASARRUS Clinic and Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-29

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2025-05-29

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

lung function
respiratory rate
FEV1
FVC
I:E ratio
Pulmonary Devices
Machine Learning

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease (COPD)