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NCT05655832

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)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·ClinicalTrials.gov·device·Device trialRecruiting
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Study focus
Disease/Condition
Pulmonary Disease, Chronic Obstructive
Drug/Device/Intervention
Vivalink wearable device
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Location
Heidelberg, Germany
Timeline & enrollment
Phase
N/A
Start date
Dec 05, 2022
End date
Jun 30, 2023
Enrollment
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, unspecifiedOther chronic obstructive pulmonary diseaseOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05655832
Type
Device Trial
About this record

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.