Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2026-02-08 @ 4:09 AM
Study NCT ID:
NCT03452618
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2018-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The study compare the diagnostic's variables in patients who received NIV one year after diagnosis and those who did not."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-26', 'studyFirstSubmitDate': '2018-02-26', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Surgical Clinical Score', 'timeFrame': 'One year after diagnostic', 'description': 'An Early Surgical Clinical Score will be established taking into account the independent variables correlated to diagnosis at early fitting.\n\nClinical Variables :\n\n* Presence of bulbar involvement or not\n* Time from onset of first symptoms to diagnosis\n* Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) score : The Amyotrophic Lateral Sclerosis Functional Ra ting Scale (ALSFRS) is an instrument for evaluating the functional status of patients with Amyotrophic Lateral Sclerosis. It can be used to monitor functional change in a patient over time.\n* Presence of another underlying respiratory disease\n\nFunctional Variables :\n\n* Time from onset of first symptoms to diagnosis of ALS\n* Presence of another underlying respiratory pathology\n* Forced Vital Capacity (FVC) measurement\n* PaCO2 measurement\n* Measure Sniff Nasal Inspiratory Pressure (SNIP)\n* Measurement of diaphragmatic activity on ultrasound\n* Parameters of the Polysomnography (PSG)'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, specificity, negative and positive predictive values', 'timeFrame': 'One year after the diagnostic', 'description': 'Sensitivity, specificity, negative and positive predictive values of the diaphragmatic ultrasound (fraction of shortening and diaphragmatic stroke) compared to the SNIP test and for the values of PSG (Polysomnography) compared to SNIP test'}, {'measure': 'Percentage of decrease', 'timeFrame': 'One year after the diagnostic', 'description': '% decrease in shortening fraction and diaphragmatic stroke between two quarterly reevaluations correlated with early fitting and % decrease in FVC, SNIP test et Pimax'}, {'measure': 'Slope of FVC decline', 'timeFrame': 'One year after the diagnostic', 'description': 'Slope of FVC decline before and after NIV implementation and slope of decline of shortening fraction and diaphragmatic stroke before and after NIV'}, {'measure': 'Quality of life score', 'timeFrame': 'One year after the diagnostic', 'description': 'Quality of life score by the Severe Respiratory Insufficiency (SRI) questionnaire :before and after implementation of the NIV The Severe Respiratory Insufficiency (SRI) Questionnaire: a specific measure of health-related quality of life in patients receiving home mechanical ventilation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnostic criteria'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'To compensate for insufficiency of diagnostic tools, the present study propose to look for the predictive factors of an early fitting by noninvasive ventilation.', 'detailedDescription': 'Amyotrophic lateral sclerosis (ALS) is the most common motor neuron disease. The diagnosis of this diaphragmatic dysfunction in the ALS subject is done all too often on the occasion of a hospitalization for acute respiratory insufficiency, which aggravates then the prognosis of the patients.\n\nThe presence of these factors at diagnosis will allow more surveillance to detect early diaphragmatic insufficiency and establish a NIV (Non Invasive Ventilation), the only therapeutic measure definitely improving the quality of life and survival of patients. A clinical score will be established to determine the risk of early Non Invasive Ventilation (NIV) equipment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of amyotrophic lateral sclerosis just performed,\n* Patient who do not have the criteria for fitting by NIV and who have a Vital capacity ≥ 70% of theoretical values\n\nExclusion Criteria:\n\n* Patient under court bail/ guardianship\n* Lack of consent for participation in the study\n* Presence of criteria for setting up the NIV for diagnosis according to the HAS (HealthCare Analytics Summit) 2006 recommendations\n* Vital capacity \\<70% of the theoretical values\n* Patient under Continuous Positive Pressure (CPP) or NIV for a respiratory pathology other'}, 'identificationModule': {'nctId': 'NCT03452618', 'acronym': 'PREDAPP', 'briefTitle': 'Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Predictive Factors for the Diagnosis of Early Noninvasive Ventilation Equipment in Patients With Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': 'RC31/17/0201'}, 'secondaryIdInfos': [{'id': '2017-A02202-51', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with a NIV equipment', 'description': 'Determination of diagnosis variables in a group of patient who benefit of the Non Invasive ventilation equipment one year after the diagnostic', 'interventionNames': ['Diagnostic Test: diagnosis variables']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients without a NIV equipment', 'description': 'Determination of diagnosis variables in a group of patient who not benefit of the Non Invasive ventilation equipment one year after the diagnostic', 'interventionNames': ['Diagnostic Test: diagnosis variables']}], 'interventions': [{'name': 'diagnosis variables', 'type': 'DIAGNOSTIC_TEST', 'description': "The study compare the diagnostic variables in patients who received Non invasive ventilation equipment one year after diagnosis with the patient who don't need it. For the independent variables, the present study determine a threshold at the diagnosis for which an early fitting risk appears\n\nThe diagnostic variable are :\n\n* Age of the patient\n* Sex\n* Presence of bulbar involvement or not\n* Time from onset of first symptoms to diagnosis of ALS\n* Score ALSFRS-R\n* Presence of another underlying respiratory pathology (COPD, asthma ...)\n* FVC measurement (Forced vital capacity)\n* PaCO2 measurement\n* Measure SNIP (Sniff nasal inspiratory pressure)\n* Measure of Pimax (Pressure inspiratory maximal)\n* Measurement of the nocturnal desaturation index (number of desaturation less than 90% per hour of sleep)", 'armGroupLabels': ['patients with a NIV equipment', 'patients without a NIV equipment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31052', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Dupuis, MD', 'role': 'CONTACT', 'email': 'dupuis.m@chu-toulouse.fr', 'phone': '5 67 77 16 91', 'phoneExt': '33'}], 'facility': 'University Hospital Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Marion Dupuis, MD', 'role': 'CONTACT', 'email': 'dupuis.m@chu-toulouse.fr', 'phone': '5 67 77 16 91', 'phoneExt': '33'}, {'name': 'Isabelle Olivier, PhD', 'role': 'CONTACT', 'email': 'olivier.i@chu-toulouse.fr', 'phone': '5 61 77 70 51', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Marion Dupuis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}