Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 11:50 PM
Study NCT ID:
NCT05762406
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2023-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of differences in VO2 expressed in mL/min/kg', 'timeFrame': '2 weeks', 'description': 'Differences in oxygen consumption (VO2) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.'}, {'measure': 'Evaluation of differences in ventilation expressed as L/min', 'timeFrame': '2 weeks', 'description': 'Differences in ventilation (VE) in different daily activities under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of differences in peripheral saturation (%)', 'timeFrame': '2 weeks', 'description': 'Differences in peripheral saturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..'}, {'measure': 'Evaluation of differences in VE/VCO2 (slope during the exercise)', 'timeFrame': '2 weeks', 'description': 'Differences in ventilation/carbon dioxide(VE/VCO2)slope under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.'}, {'measure': 'Evaluation of differences in heart rate (beats/min)', 'timeFrame': '2 weeks', 'description': 'Differences in heart rate (HR) under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.'}, {'measure': 'Evaluation of differences in dyspnea (Borg scale)', 'timeFrame': '2 weeks', 'description': 'Differences in dyspnea grade evaluated by Borg scale under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients.'}, {'measure': 'Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal apneas (number of events)', 'timeFrame': '2 weeks', 'description': 'Differences in nocturnal apneas under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..'}, {'measure': 'Evaluation of differences in cardiorespiratory parameters during sleep: nocturnal hypopnea (number of events)', 'timeFrame': '2 weeks', 'description': 'Differences in nocturnal hypopneas events under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..'}, {'measure': 'Evaluation of differences in nocturnal desaturation (%)', 'timeFrame': '2 weeks', 'description': 'Differences in nocturnal desaturation under basal conditions and while wearing the protective mask (FFP2) in healthy subjects, heart failure patients and in COPD patients..'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'COPD']}, 'descriptionModule': {'briefSummary': 'Scientific Rationale: In late 2019 and early 2020, researchers at the Wuhan Institute of Virology identified a potential new etiologic agent, called new coronavirus 2019 (nCoV-2019). Subsequently, the epidemic unleashed by this virus involved the whole world and radically changed the habits of the entire global population. Since that time, in fact, the need to contain the spread of infection through specific social distancing procedures and through the use of personal protective equipment has become compelling. The main tool was the requirement for all citizens to wear masks for airway protection. This measure has thus become in daily use for the majority of the population.\n\nTherefore, it has become increasingly important to evaluate the impact of mask wearing on activities of daily living (ADls), both in healthy subjects, for which several evidences have already been brought, and in patients with different diseases, for which data are still insufficient to fully describe the effects.\n\nOxygen consumption and dyspnea during simple activities of daily living (ADLs) have already been studied in patients with heart failure (HF) and chronic obstructive pulmonary disease (COPD), and there is evidence that these subjects compared with healthy subjects perform ADLs at a higher percentage of their peak VO2 with more dyspnea. However, there are still no studies highlighting, however, the consequences of performing such activities while wearing a protective filtering facepiece particles class 2 (FFP2) mask, to date considered the most suitable to preserve the most fragile subjects from infection.\n\nIn this study, therefore, the investigators aim to asess the effects of these devices on the ability to perform ADLs by evaluating the exchanges of respiratory gases in the body during the performance of normal activities or during sleep in patients with HF or COPD compared with healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy subjects:\n\n* Age: 18-80 years\n* Not taking cardiovascular medications\n* No history of cardiovascular disease\n* Normal physical examination\n* Normal ECG\n\nInclusion criteria for subjects with HF:\n\n* Age: 18-80 years\n* New York Heart Association Class (NYHA) II to III in stable clinical condition\n* Left ventricular ejection fraction (LVEF) \\<40%\n* Ability to perform a maximal CPET\n\nPatients with COPD:\n\n* Age: 18-80 years\n* Diagnosis of COPD stage GOLD II-III in stable clinical condition\n* Absent concomitant heart disease\n* Ability to perform a maximal CPET\n\nExclusion Criteria:\n\n* Healthy subjects:\n* Presence of concomitant diseases\n\nPatients:\n\n* Oxygen therapy\n* Inability or contraindication to perform a maximal CPET'}, 'identificationModule': {'nctId': 'NCT05762406', 'briefTitle': 'Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Effect of the Use of Protective Masks on the Ability to Perform Daily Activities in Patients with Heart Failure or Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'CCM1550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wearing mask', 'description': 'Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask', 'interventionNames': ['Device: Respiratory protective mask']}, {'type': 'NO_INTERVENTION', 'label': 'Not wearing mask', 'description': 'Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities in basal conditions'}], 'interventions': [{'name': 'Respiratory protective mask', 'type': 'DEVICE', 'description': 'Subjects will perform a cardiopulmonary exercise test (CPET) and a series of standardized daily activities while wearing a protective mask.\n\nDuring the exercises, oxygen consumption, ventilation and other cardiorespiratory parameters will be assessed using a portable device (K5, Cosmed)', 'armGroupLabels': ['Wearing mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino, Irccs', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Cardiologico Monzino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}