Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT05655832
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-09-03', 'releaseDate': '2025-08-13'}, {'resetDate': '2025-10-17', 'releaseDate': '2025-09-26'}, {'resetDate': '2025-12-01', 'releaseDate': '2025-11-17'}], 'estimatedResultsFirstSubmitDate': '2025-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of COPD exacerbations', 'timeFrame': '3 months'}, {'measure': 'Severity of exacerbations', 'timeFrame': '3 months', 'description': 'Severity of acute exacerbations of COPD (AECOPD) are defined using the GOLD definitions based on treatment consequences (event-based): 1) mild if they are treated with short-acting bronchodilators only; 2) moderate if they are treated with short-acting bronchodilators plus antibiotics and/or oral corticosteroids; or 3) severe if the patient visits the emergency room or requires hospitalization because of an exacerbation.'}], 'secondaryOutcomes': [{'measure': "COPD Assessment Test (CAT) Questionnaire: Patients' health status and symptoms at baseline and study end", 'timeFrame': 'Baseline (Day 0) and at 3 months', 'description': "Patients' health status and symptoms at baseline (Day 0) and study end will be measured as the summary score across items of the CAT questionnaire that consists of 8-items in which participants can choose a score from 0 to 5, for each visit"}, {'measure': 'Lung function measuring Forced Expiratory Volume in 1 second (FEV1) as assessed using body plethysmography', 'timeFrame': 'Baseline (Day 0) and at 3 months'}, {'measure': 'Lung function measuring FEV1 / Forced Vital Capacity (FVC) as assessed using body plethysmography', 'timeFrame': 'Baseline (Day 0) and at 3 months'}, {'measure': 'Number of COPD exacerbations', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS202559_0001', 'label': 'Trial Awareness and Transparency website'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor participants with COPD:\n\n* Participants ≥40 and ≤80 years at baseline\n* Diagnosis of COPD stage II to IV\n* 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)\n\nFor participants in the calibration cohort:\n\n• Participants ≥40 and ≤80 years at baseline\n\nExclusion Criteria:\n\nFor participants with COPD:\n\n* 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\n* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices\n* Participants with known allergies or sensitivity to silicon or hydrogel\n* Less than 6 weeks since previous moderate/severe exacerbation\n\nFor participants in the calibration cohort:\n\n* Participants with a cardiac pacemaker, defibrillators, or other implanted electronic devices\n* Participants with known allergies or sensitivity to silicon or hydrogel\n* Diagnosis of pulmonary disease including, but not limited to COPD, asthma, pulmonary fibrosis, with impact on the lung function and exercise capacity"}, 'identificationModule': {'nctId': 'NCT05655832', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'MS202559_0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'COPD cohort', 'interventionNames': ['Device: Vivalink wearable device']}, {'type': 'EXPERIMENTAL', 'label': 'Calibration participants cohort', 'interventionNames': ['Device: Vivalink wearable device']}], 'interventions': [{'name': 'Vivalink wearable device', 'type': 'DEVICE', 'description': 'a CE marked device modified to add a temperature measurement algorithm in addition to ECG and respiratory rate measurements', 'armGroupLabels': ['COPD cohort', 'Calibration participants cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Praxis an der Oper', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Lungenzentrum Darmstadt GmbH', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Städtische Kliniken Darmstadt', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Lungenzentrum Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg gGmbH', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'ZERO Praxen', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'München', 'country': 'Germany', 'facility': 'Pneumologisches Studienzentrum München-West', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Saarbrücken', 'country': 'Germany', 'facility': 'Pneumologische Gemeinschaftspraxis Saarbrücken', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'city': 'Schleswig', 'country': 'Germany', 'facility': 'RespiRatio / Lungenpraxis', 'geoPoint': {'lat': 54.52021, 'lon': 9.56829}}, {'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Pneumologische Praxis Wiesbaden', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'city': 'Witten', 'country': 'Germany', 'facility': 'Lungenpraxis Dr. Franz / Dr. Weber', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-08-13', 'type': 'RELEASE'}, {'date': '2025-09-03', 'type': 'RESET'}, {'date': '2025-09-26', 'type': 'RELEASE'}, {'date': '2025-10-17', 'type': 'RESET'}, {'date': '2025-11-17', 'type': 'RELEASE'}, {'date': '2025-12-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}}}}