Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-31 @ 4:47 AM
Study NCT ID:
NCT04563832
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2020-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Control group: standardized respiratory management.\n* Experimental group: same program, associated with the daily use of a hyperinsufflation technique.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.', 'timeFrame': '24 months', 'description': 'This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy'}], 'secondaryOutcomes': [{'measure': 'Effect of COUGH-ASSIST on slowing the decline in respiratory function,', 'timeFrame': '12 months and 24 months', 'description': 'This will be demonstrated by monitoring respiratory function by spirometry'}, {'measure': 'Functional effectiveness of COUGH-ASSIST', 'timeFrame': '12 months and 24 months', 'description': 'By using the goal attainmentscaling method (GAS)'}, {'measure': 'Tolerance and compliance with COUGH-ASSIST,', 'timeFrame': '24 months', 'description': 'This will be evaluated via an online "patient reported outcomes form" and data readings from the internal memory of the COUGH-ASSIST'}, {'measure': 'Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection', 'timeFrame': '24 months', 'description': 'This will be evaluate by the number of serious respiratory infection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.\n\nThis insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology', 'detailedDescription': 'During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.\n\nEvidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed MS diagnosis (McDonald criteria)\n* EDSS ≥ 7\n* Age greater than or equal to 18 years.\n* Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.\n\nExclusion Criteria:\n\n* ENT and / or thoracic surgery less than 6 months old\n* Progressive or past pneumothorax / pneumomediastinum\n* Severe swallowing disorders.\n* Inability to use the device under study'}, 'identificationModule': {'nctId': 'NCT04563832', 'acronym': 'MS-COUGH', 'briefTitle': 'Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit', 'orgStudyIdInfo': {'id': 'APHP2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control group', 'description': 'standardized respiratory management.', 'interventionNames': ['Other: Standardized respiratory management program']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years)', 'interventionNames': ['Other: Standardized respiratory management program', 'Other: CoughAssist']}], 'interventions': [{'name': 'Standardized respiratory management program', 'type': 'OTHER', 'description': 'Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'CoughAssist', 'type': 'OTHER', 'description': 'self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Haut de Seine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan LEVY, Dr', 'role': 'CONTACT', 'phone': '01.4710.70.60'}], 'facility': 'Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'centralContacts': [{'name': 'Jonathan LEVY, Dr', 'role': 'CONTACT', 'email': 'jonathan.levy2@aphp.fr', 'phone': '+33 147107900'}, {'name': 'Hélène PRIGENT, Pr', 'role': 'CONTACT', 'email': 'helene.prigent@aphp.fr', 'phone': '+33 147107900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}