Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04729920
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2021-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home Use of Mechanical Insufflation/Exsufflation Devices 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-31', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to MI-E (reported)', 'timeFrame': '12 months, or since treatment initiation (> 3 months)', 'description': 'based on self-reported use'}, {'measure': 'Adherence to MI-E (objective)', 'timeFrame': '12 months, or since treatment initiation (> 3 months)', 'description': 'based on data downloads'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with the device', 'timeFrame': '12 months, or since treatment initiation (> 3 months)', 'description': 'Self-report questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Mechanical insufflation-exsufflation', 'Cough assistance'], 'conditions': ['Neuromuscular Diseases']}, 'descriptionModule': {'briefSummary': 'With this cross-sectional study of adult subjects with neuromuscular disease in the French-speaking part of Switzerland, we aim to explore MI-E adherence using self-report questionnaires and device data in order to identify the factors that influence the pattern of MI-E use and satisfaction with the treatment. Determining potential barriers to regular long-term home use of MI-E could help in identifying the patients who would benefit most from this therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Diagnosis of neuromuscular disease\n* Active prescription of MI-E for more than 3 months\n\nExclusion Criteria:\n\n-Invasive airway'}, 'identificationModule': {'nctId': 'NCT04729920', 'briefTitle': 'Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Predictors of Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Patients: a Cross-sectional Study', 'orgStudyIdInfo': {'id': '2019-01114'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'subjects with neuromuscular disease', 'description': 'Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months', 'interventionNames': ['Device: Mechanical insufflation/exsufflation device (MI-E)']}], 'interventions': [{'name': 'Mechanical insufflation/exsufflation device (MI-E)', 'type': 'DEVICE', 'description': 'download of device (MI-E) data and self-reported satisfaction with the device', 'armGroupLabels': ['subjects with neuromuscular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Service de Pneumologie, CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue Pulmonaire Vaudoise', 'class': 'UNKNOWN'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cheffe de clinique', 'investigatorFullName': 'GEORGIA MITROPOULOU', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}