Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-08 @ 1:00 PM
Study NCT ID:
NCT02759003
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-04-28', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence as measured by the use of ventilator (hours/month)', 'timeFrame': 'At 3 months', 'description': 'Evaluation after 3 months from the end of NIV initiation trial (T2)'}], 'secondaryOutcomes': [{'measure': 'Changes in respiratory function as assessed by spirometry', 'timeFrame': 'At 3 months', 'description': 'Evaluation at 3 months from the end of NIV initiation trial (T2)'}, {'measure': 'Changes in dyspnea symptoms as assessed by Visual Analogue Scale', 'timeFrame': 'At 3 months', 'description': 'Evaluation at 3 months from the end of NIV initiation trial (T2)'}, {'measure': "Patient's questionnaire of satisfaction", 'timeFrame': 'At 20 days', 'description': 'Evaluation at the end of NIV initiation trial (T1)'}, {'measure': 'Changes in respiratory function as assessed by Maximal inspiratory pressure/Maximal expiratory pressure', 'timeFrame': 'At 3 months', 'description': 'Evaluation at 3 months from the end of NIV initiation trial (T2)'}, {'measure': 'Changes in respiratory function as assessed by blood gas analysis', 'timeFrame': 'At 3 months', 'description': 'Evaluation at 3 months from the end of NIV initiation trial (T2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': "In patients with amyotrophic lateral sclerosis (ALS), non-invasive mechanical ventilation (NIV) is usually initiated in an in-hospital regime. The investigators evaluated if NIV initiated in an outpatient setting can be as effective as regards patients' adherence. The investigators also evaluated factors predicting NIV adherence and disease progression.", 'detailedDescription': "All patients with a definite ALS diagnosis, aged \\> 18 years, referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and Istituto Don Gnocchi Onlus (Milano), Italy, for respiratory functional assessments for the purpose of early initiation of NIV were considered. Patients who were in clinically stable condition and without chest infections during the previous 3 months were considered eligible for the study.\n\nBetween March 2011 and March 2014, during an outpatient visit, the patients were randomized 1:1 to two groups for NIV initiation: outpatient vs. inpatient protocol.\n\nIn both groups a diurnal NIV initiation trial was performed using pressure-support ventilators in spontaneous/timed mode with a preset tidal volume (300 ml/kg) and a fixed back-up respiratory rate (12 breaths/min). The trial included: choice of the mask, setting of ventilator pressure, at least 2 hours of NIV under supervision.\n\nThen, the patients underwent the nighttime NIV initiation trial for a maximum of 20 nights according to the outpatient vs. inpatient protocol.\n\nNIV trial was stopped when: 1) patients used NIV \\> 4 hours/night for 3 consecutive nights, 2) patients and caregivers were able to manage with ventilator, 3) patients failed after 10 consecutive educational sessions.\n\nAt enrollment (T0), the end of NIV initiation trial (T1) and after 3 months from the end of the trial (T2) respiratory function tests, blood gas analysis, and sleep study were performed.\n\nAt T1 the investigators assessed NIV acceptance (as a minimum of 3 consecutive days \\>4 h/night), and dyspnea symptoms by VAS (day/night), staff and patients' satisfaction.\n\nAt T2: NIV adherence (\\>120 h/month) and patients' satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consecutive patients\n* definite ALS diagnosis\n* aged \\> 18 years\n* in clinically stable condition\n* referred to the ALS outpatient clinics of the Fondazione Salvatore Maugeri Institute of Lumezzane (Brescia) and the Istituto Don Gnocchi Onlus (Milano), Italy for respiratory functional assessment for the purpose of early initiation of NIV\n* no chest infections during the previous 3 months.\n\nExclusion Criteria:\n\n* cognitive impairment\n* refusal to participate\n* severe comorbidities and contraindications to NIV (arrhythmias, cardiac failure, history of pneumothorax)\n* distance from hospital \\> 40 km, travel problems to attend the outpatient clinic'}, 'identificationModule': {'nctId': 'NCT02759003', 'briefTitle': 'Nightime NIV Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Salvatore Maugeri'}, 'officialTitle': 'Nightime Noninvasive Mechanical Ventilation Initiation in Amyotrophic Lateral Sclerosis in an Outpatient Setting. A Non-inferiority Study.', 'orgStudyIdInfo': {'id': 'CTS 02/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'inpatients group', 'description': 'In-hospital nightime NIV initiation. For the inpatients Group, NIV was initiated in the respiratory wards of the two hospitals and continued during night for a minimum of 4 hours/night.\n\nInpatients had a 24-h availability of health staff care. During the night, they had nurses and physicians available on-hand.', 'interventionNames': ['Procedure: Nightime NIV initiation']}, {'type': 'EXPERIMENTAL', 'label': 'outpatients group', 'description': 'Home nightime NIV initiation. For the outpatients group, diurnal NIV was initiated during a scheduled visit in a hospital dedicated room(at least 4 hours/day of care), the trial proceeded at home during the night with a personal caregiver.\n\nA minimum of 4 hours/night was required. No support during the night was provided to these patients.', 'interventionNames': ['Procedure: Nightime NIV initiation']}], 'interventions': [{'name': 'Nightime NIV initiation', 'type': 'PROCEDURE', 'description': 'In-hospital vs home', 'armGroupLabels': ['inpatients group', 'outpatients group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Enrica Bertella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Salvatore Maugeri'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enrica Bertella', 'investigatorAffiliation': 'Fondazione Salvatore Maugeri'}}}}