Effectiveness of the WearME System for COPD Severity and Respiratory Function

NCT06751537 | Recruiting

• 2 other identifiers: LAS-01-WZ-0231R44HL172444-01A1
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 6 months of study start.

Secondary Outcomes (4)

• Accuracy of WearME-Basic in measuring Respiration Rate

  Within 6 months of study start.

• Accuracy of WearME-Basic in measuring I:E ratio

  Within 6 months of study start.

• Accuracy of WearME-Basic in measuring Heart Rate

  Within 6 months of study start.

• Accuracy of WearME-Basic in measuring ROM

  Within 6 months of study start.

Study Arms (1)

COPD Participants

Participants are wearing the WearME device and undergoing reference testing

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult COPD patients recruited from outpatient clinics at LASARRUS, Johns Hopkins, and TidalHealth.

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• LASARRUS Clinic and Research Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Johns Hopkins University: collaborator
• Tidalhealth: collaborator
• Tidalhealth, Inc.: collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator

Study Sites (2)

Johns Hopkins

Baltimore, Maryland, 21224, United States

RECRUITING

TidalHealth

Salisbury, Maryland, 21801, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32073625 BACKGROUND

• Lokke 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.

  PMID: 33731990 BACKGROUND

• GBD 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.

  PMID: 32526187 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: May 29, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (2)