Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05815420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-20
First Post:
2023-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of unplanned all-cause hospitalisations in routine clinical care in patients treated with NIV therapy who are continuously monitored by telemetric data', 'timeFrame': '1 year', 'description': 'Rate of unplanned all-cause hospitalisations in the study population normalised to one year of follow up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non invasive ventilation', 'Telemonitoring'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Tele-monitoring emerged and unfolded differently among various healthcare organisations and countries. Evidence regarding its impact on the management of COPD patients is still insufficient to draw firm conclusions. Assumption has been made that remote monitoring of home NIV treatment could help to identify novel predictors of the early detection of NIV failure and deteriorations in patients with COPD.\n\nThe incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data in France needs evaluation.\n\nIn addition, predictors of unplanned all-cause and COPD-caused hospitalisations as well as of compliance and persistence to NIV therapy should be assessed in this patient population with special respect to continuous tele-monitoring.\n\nThe study will determine in France the incidence in routine clinical care of unplanned all-cause and COPD-caused hospitalisations in patients treated with NIV therapy who are continuously monitored by telemetric data. Clinical and telemetric predictors of unplanned all-cause and COPD-caused hospitalisations and of NIV therapy compliance and persistence will be assessed in those patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD Patient with a first prescription of NIV treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age ≥18 years\n* COPD eligible for NIV treatment\n* Prescription of an adequate ResMed NIV device with tele-monitoring option as part of routine clinical care\n* Acceptance of tele-monitoring and corresponding data handling\n* Naive to long-term NIV treatment with initiation of NIV either ≤7 days before or after enrolment into study\n* Able to fully understand information on data protection and provide written informed consent for use of corresponding medical and telemetric data.\n\nExclusion criteria:\n\n* Invasive ventilation therapy\n* Another life-threatening disease with estimated survival \\< 12 months (other than COPD, e.g. cancer)\n* Further exclusion criteria according to manua of the device intended and prescribed'}, 'identificationModule': {'nctId': 'NCT05815420', 'acronym': 'HOV-C', 'briefTitle': 'Home Tele-Monitoring of Non-Invasive Ventilation in COPD Patients in France', 'organization': {'class': 'OTHER', 'fullName': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche'}, 'officialTitle': 'Home Tele-Monitoring of Non-Invasive Ventilation in Chronic Obstructive Pulmonary Disease in France', 'orgStudyIdInfo': {'id': '2023-A00565-40'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non invasive ventilation', 'type': 'DEVICE', 'description': 'Treatment by non invasive ventilation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}