Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT06578156
Status:
RECRUITING
Last Update Posted:
2024-12-16
First Post:
2024-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-08-28', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-minute walk test', 'timeFrame': '30 minutes', 'description': 'The object of the test is to walk as far as possible for six minutes. The subject will walk at a normal pace around a marked course for six minutes. The distance walked in meters over 6 minutes will be measured.'}], 'secondaryOutcomes': [{'measure': 'Breathing measured by the Borg dyspnea scale', 'timeFrame': '30 minutes', 'description': 'This is a patient self-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, where "0" indicated no difficulty breathing, and "10" indicates a maximal breathing difficulty.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to consent\n* Age 18 years or older\n* Diagnosis of COPD\n* Ability to ambulate without assistance\n* Use of low-flow nasal cannula ≤ 4 L/min or no supplemental oxygen (O2) at all\n\nExclusion Criteria:\n\n* Pregnancy\n* Being on bedrest\n* Inability to consent or cooperate with the study\n* Using of \\> 4 L/min of supplemental O2 or requiring non-invasive ventilation during the daytime\n* Hemodynamic instability (resting heart rate \\> 130/minute, systolic blood pressure of ≤ 90 mmHg or ≥ 180 mmHg)\n* Metal implants in the thoracic regions (pacemakers, Automatic Implantable Cardioverter Defibrillator (AICD), plates, screws, rods, and disc replacements)'}, 'identificationModule': {'nctId': 'NCT06578156', 'briefTitle': 'Physiologic Effects of Nasal High Flow on Exercise Tolerance in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Physiologic Effects of Nasal High Flow on Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '20240476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal High Flow Cannula', 'description': 'Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes', 'interventionNames': ['Device: Nasal High Flow Cannula', 'Device: Nasal Low Flow Cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nasal Low Flow Cannula', 'description': "Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes", 'interventionNames': ['Device: Nasal High Flow Cannula', 'Device: Nasal Low Flow Cannula']}], 'interventions': [{'name': 'Nasal High Flow Cannula', 'type': 'DEVICE', 'description': "High flow nasal cannula is a device that provides heated and humidified high flow gases. In-person. Depending on participant's availability, up to 6 times", 'armGroupLabels': ['Nasal High Flow Cannula', 'Nasal Low Flow Cannula']}, {'name': 'Nasal Low Flow Cannula', 'type': 'DEVICE', 'description': "Low flow nasal cannula is a device that provides low flow gases. In-person. Depending on participant's availability, up to 6 times", 'armGroupLabels': ['Nasal High Flow Cannula', 'Nasal Low Flow Cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Saramaria Afanador Castiblanco, M.D.', 'role': 'CONTACT', 'email': 'saramaria.afanador@miami.edu', 'phone': '305-243-2568'}, {'name': 'Saramaria Afanador Castiblanco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Saramaria Afanador Castiblanco, M.D.', 'role': 'CONTACT', 'email': 'saramaria.afanador@miami.edu', 'phone': '305-243-2568'}], 'overallOfficials': [{'name': 'Saramaria Afanador Castiblanco, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Thoracic Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Saramaria Afanador Castiblanco', 'investigatorAffiliation': 'University of Miami'}}}}