Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-04-17 @ 9:46 AM
Study NCT ID:
NCT03130361
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2016-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Wearable Noninvasive Positive Pressure Ventilation Device in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-01', 'studyFirstSubmitDate': '2016-08-16', 'studyFirstSubmitQcDate': '2017-04-21', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance to the device', 'timeFrame': 'Every week over the 4-week period', 'description': 'During a weekly phone call, patients will indicate the daily duration and conditions of use of the device'}, {'measure': 'Number of acute exacerbation', 'timeFrame': 'Up to 12 months before the date of inclusion', 'description': "Exacerbation is defined as changing the respiratory status of the patient relative to the patient's usual state, which requires acute hospitalisation."}, {'measure': 'Weight', 'timeFrame': 'baseline and post use of the Vitabreath device at 4th weeks', 'description': 'Patient will indicate their weight'}], 'primaryOutcomes': [{'measure': 'Change of daily physical activity measured by actimetry', 'timeFrame': 'Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device', 'description': 'Change of number of steps by day and daily energy expenditure over the 8 week period'}], 'secondaryOutcomes': [{'measure': 'Change of Baseline Dyspnea Index (BDI) score', 'timeFrame': 'baseline and post use of the Vitabreath device at 4th weeks', 'description': 'The BDI represents importance and impact of dyspnea in daily life of COPD patients. The BDI is one of dyspnea parameters (questionnaire). Three dimension questions include; 1.effect of daily function on dyspnea, 2. effect of magnitude of task on dyspnea and 3. effect of magnitude off effort on dyspnea.'}, {'measure': 'Change of Modified Medical Research Council Questionnaire (mMRC) score', 'timeFrame': 'baseline and post use of the Vitabreath device at 4th weeks', 'description': 'The mMRC is one of dyspnea parameters'}, {'measure': 'Change of Transition Dyspnea Index (TDI)', 'timeFrame': 'baseline and post use of the Vitabreath device at 4th weeks', 'description': 'The TDI assesses change of dyspnea perception from the BDI in each dimensions. Patient will rate score from -6 to +6 (positive score reflect improve of dyspnea and negative score reflect worse dyspnea).'}, {'measure': 'Subjective appréciation of the device', 'timeFrame': 'post use of the Vitabreath device at 4th weeks', 'description': 'Patients will rate their appreciation of the device using 3 scale relatives to ease of use, helps recovery shortness of breath, helps to be more active in daily life'}, {'measure': 'Change of Visual Simplified Respiratory Questionnaire (VSRQ) score', 'timeFrame': 'baseline and post use of the Vitabreath device at 4th weeks', 'description': 'The VRSQ represents health related quality of life of COPD patients'}, {'measure': 'Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT)score', 'timeFrame': 'Continuously over a 8-week period (2 weeks before the use of the device, over the 4-week period usinf the device and 2 weeks after the use of the device', 'description': 'The CAT represents health related quality of life of COPD patients'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-Invasive Ventilation']}, 'descriptionModule': {'briefSummary': 'The objective is to assess the impact of a wearable Noninvasive Positive Pressure Ventilation, on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.', 'detailedDescription': 'In order to avoid the occurrence of uncomfortable dyspnea, patients with Chronic Obstructive Pulmonary Disease (COPD) are locked in a vicious circle of inactivity and social isolation which profoundly affects their quality of life and prognosis. A new wearable non invasive positive pressure ventilation device has been recently proposed; it can be used by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea- recovery time. The investigators hypothesize that this system, in reducing the inconvenience caused by dyspnea, would stimulate a more active lifestyle and improve quality of life. Their objective is to assess the impact of this device on physical activity and quality of life in patients with severe COPD, complaining of dyspnea.\n\nIn this open study with no control group, participants will use the device at their convenience, according to their needs in daily life and for 4 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with stable severe COPD (with FEV1 ≤50% predicted)\n* Patients with mMRC score \\> ou = 2.\n\nExclusion Criteria:\n\n* Exacerbate within a month prior.\n* Using other non invasive ventilation device \\> 15h per day.\n* Have musculoskeletal or neuromuscular problem affecting balance and walking.\n* Have cognitive problem affecting comprehension of the different évaluations or questionnaires.\n* Have recently participated in physical training or rehabilitation program (≤ 3 months).\n* Medical contra-indication to NIV.\n* Evolutionary pathologies (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing).\n* Simultaneously enrolled in an other clinical trial.\n* Not affiliated to social security.\n* Person deprived of liberty, major protected by law.'}, 'identificationModule': {'nctId': 'NCT03130361', 'acronym': 'VITABREATH', 'briefTitle': 'Wearable Noninvasive Positive Pressure Ventilation Device in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Icadom'}, 'officialTitle': 'Evaluation of the Impact of a Wearable Noninvasive Positive Pressure Ventilation Device on Physical Activity and Quality of Life in Patients With COPD', 'orgStudyIdInfo': {'id': '2016-A01297-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Noninvasive ventilation', 'description': 'Participants will use the device at home by intermittence during or after physical activities for reducing dyspnea or for shortening dyspnea-recovery time over a 4-week period.', 'interventionNames': ['Device: Non-Invasive Ventilation']}], 'interventions': [{'name': 'Non-Invasive Ventilation', 'type': 'DEVICE', 'armGroupLabels': ['Noninvasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30100', 'city': 'Alès', 'country': 'France', 'facility': 'Dr Michèle Bognie Pneumology Office', 'geoPoint': {'lat': 44.12489, 'lon': 4.08082}}, {'zip': '34000', 'city': 'Castelnau-le-Lez', 'country': 'France', 'facility': 'Clinique du Parc', 'geoPoint': {'lat': 43.63605, 'lon': 3.90137}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU Grenoble-Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59042', 'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Privé La Louvière', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '34400', 'city': 'Lunel', 'country': 'France', 'facility': 'Dr Christian PAILLARGUELO Pneumology Office', 'geoPoint': {'lat': 43.67778, 'lon': 4.13611}}, {'zip': '30900', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Caremeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Jean-Louis PEPIN, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratoire du sommeil - Centre hospitalier Universitaire Michallon - 38043 GRENOBLE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icadom', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Philips Respironics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}