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A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD | Clinical Trials | Clareo Health

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A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

NCT05655832•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring disease activity and predicting exacerbations for participants with Chronic Obstructive Pulmonary Disease (COPD). The cohort of participants with COPD will be followed for 3 months. A calibration cohort with non-COPD participants will be included and followed for 2 weeks.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For participants with COPD:
•Participants ≥40 and ≤80 years at baseline
•Diagnosis of COPD stage II to IV
•History of moderate or severe exacerbations (≥2 moderate exacerbations or ≥1 severe exacerbations in any 12-month time window during last 3 years prior to inclusion and ≥1 moderate or severe exacerbations in the last 12 months prior to inclusion, considering that the last 12 months may reflect lower exacerbation rate due to Covid-19 measures)
•For participants in the calibration cohort:
•Participants ≥40 and ≤80 years at baseline

Exclusion Criteria

•For participants with COPD:
•Clinically relevant and/or serious concurrent medical conditions including, but not limited to visual problems, severe mental illness or cognitive impairment, musculoskeletal or movement disorders, cardiac disease (e.g., heart failure, arrythmia \[esp. atrial fibrillation and conduction blocks\]), lung cancer (currently treated) that in the opinion of the Investigator, would interfere with participant's ability to participate in the study or draw meaningful conclusions from the study
•Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
•Participants with known allergies or sensitivity to silicon or hydrogel
•Less than 6 weeks since previous moderate/severe exacerbation
•For participants in the calibration cohort:
•Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices
•Participants with known allergies or sensitivity to silicon or hydrogel
•Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity

Locations (11)

Praxis an der Oper

Berlin, Germany

Lungenzentrum Darmstadt GmbH

Darmstadt, Germany

Städtische Kliniken Darmstadt

Darmstadt, Germany

Lungenzentrum Frankfurt

Frankfurt, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

ZERO Praxen

Mannheim, Germany

Pneumologisches Studienzentrum München-West

München, Germany

Pneumologische Gemeinschaftspraxis Saarbrücken

Saarbrücken, Germany

RespiRatio / Lungenpraxis

Schleswig, Germany

Pneumologische Praxis Wiesbaden

Wiesbaden, Germany

Key Dates

Start Date

December 5, 2022

Primary Completion Date

October 31, 2023

Completion Date

October 31, 2023

Last Updated

January 15, 2026

Enrollment

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Vivalink wearable device

DEVICE

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

View study

RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The London COPD Exacerbation Cohort

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