Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02537132
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"New Perspectives of Adaptation to NIV in ALS"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000064', 'term': 'Acclimatization'}], 'ancestors': [{'id': 'D000222', 'term': 'Adaptation, Physiological'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000220', 'term': 'Adaptation, Biological'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-01'}, 'lastUpdateSubmitDate': '2018-08-01', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-08-28', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in adherence NIV in ALS patients at baseline, 2 and 4 months as measured by monthly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)', 'timeFrame': 'Baseline + after 2 and 4 months from the recruitment', 'description': 'The primary outcome the time of adherence to NIV defined as actual use of NIV for not less than 150 hours / month.'}]}, 'conditionsModule': {'keywords': ['Non Invasive Ventilation (NIV)', 'Amyotrophic Lateral sclerosis (ALS)', 'adaptation', 'home care'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALS diagnosis according to the criteria of El Escorial;\n* Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);\n* No respiratory infection within 3 months\n* Severe disability (ALS-FRS \\<31);\n* Age \\> 18 years;\n* The voluntary participation to the Study.\n\nExclusion Criteria:\n\n\\-- Previous episodes of pneumothorax;\n\n* Comorbid cardiac and / or renal important\n* Severe cognitive impairment;\n* Refusal of the patient at the time of Informed Consent.'}, 'identificationModule': {'nctId': 'NCT02537132', 'briefTitle': '"New Perspectives of Adaptation to NIV in ALS"', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': '"New Perspectives of Adaptation to Non-Invasive Ventilation (NIV) in Amyotrophic Lateral Sclerosis (ALS)"', 'orgStudyIdInfo': {'id': 'FDG_ALS1H_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home Group', 'description': 'Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at home', 'interventionNames': ['Other: Adaptation and training to Non Invasive Ventilation (NIV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient Group', 'description': 'Adaptation and training to Non Invasive Ventilation (NIV) (not less than five sessions), at the outpatient clinic', 'interventionNames': ['Other: Adaptation and training to Non Invasive Ventilation (NIV)']}], 'interventions': [{'name': 'Adaptation and training to Non Invasive Ventilation (NIV)', 'type': 'OTHER', 'description': "Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition.", 'armGroupLabels': ['Home Group', 'Outpatient Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25065', 'city': 'Lumezzane', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Michele Vitacca', 'geoPoint': {'lat': 45.64789, 'lon': 10.26487}}, {'zip': '20149', 'city': 'Milan', 'country': 'Italy', 'facility': 'Paolo Banfi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}