Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-02-26 @ 12:43 AM
Study NCT ID:
NCT02137304
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2014-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2014-05-09', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'optimal negative pressure treshold value', 'timeFrame': '20 minutes', 'description': 'Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute'}], 'secondaryOutcomes': [{'measure': 'optimal pressure treshold based on the best peak flow.', 'timeFrame': '10 minutes'}, {'measure': 'volume-flow curve aspect', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cough help', 'in-exsufflation', 'neuromuscular disease', 'cough assistance optimization', 'efficient cough flow'], 'conditions': ['Neuromuscular Disease']}, 'referencesModule': {'references': [{'pmid': '31351076', 'type': 'DERIVED', 'citation': 'Lacombe M, Bore A, Amo Castrillo LD, Boussaid G, Falaize L, Vlachos E, Orlikowski D, Prigent H, Lofaso F. Peak Cough Flow Fails to Detect Upper Airway Collapse During Negative Pressure Titration for Cough-Assist. Arch Phys Med Rehabil. 2019 Dec;100(12):2346-2353. doi: 10.1016/j.apmr.2019.06.012. Epub 2019 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.', 'detailedDescription': 'he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* man or female age18 years\n* neuromuscular disease\n* coughassist adaptation treatment\n* peak cough flow\\<270liter/minute\n\nExclusion Criteria:\n\n* acute organ failure\n* insufflation contrindication\n* pregnant women/no affiliation to a social security scheme\n* plan of legal protection'}, 'identificationModule': {'nctId': 'NCT02137304', 'acronym': 'COUGHELP', 'briefTitle': 'A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases', 'orgStudyIdInfo': {'id': '2013-A01771-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'neuromuscular patients', 'description': 'Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)', 'interventionNames': ['Device: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)']}], 'interventions': [{'name': 'Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)', 'type': 'DEVICE', 'description': 'Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow', 'armGroupLabels': ['neuromuscular patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Hôpital R. POINCARE', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Frederic LOFASO, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Hopital R. Poincaré Garches'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}