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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 - Trial NCT05655832

Access comprehensive clinical trial information for NCT05655832 through Pure Global AI's free database. This phase not specified trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany and is currently Recruiting. The study focuses on Pulmonary Disease, Chronic Obstructive. Target enrollment is 77 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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ClinicalTrials.gov โ€ข NCT05655832
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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
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 Chronic Obstructive Pulmonary Disease (COPD)

Study Focus

Vivalink wearable device

Interventional

device

Sponsor & Location

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

Heidelberg, Germany

Timeline & Enrollment

N/A

Dec 05, 2022

Jun 30, 2023

77 participants

Primary Outcome

Occurrence of COPD exacerbations,Severity of exacerbations

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.

ICD-10 Classifications

Chronic obstructive pulmonary disease, unspecified
Other chronic obstructive pulmonary disease
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT05655832

Device Trial