Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-27 @ 1:09 AM
Study NCT ID:
NCT03764150
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2018-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009223', 'term': 'Myotonic Dystrophy'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020967', 'term': 'Myotonic Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2018-11-19', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of measurement of spirometry', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation'}, {'measure': 'Change respiratory force', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation to change Inspiratory and expiratory force'}, {'measure': 'Change CO2 response (Read test)', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation'}, {'measure': 'Change subjective sleepiness (Epworth)', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation'}, {'measure': "change Krupp's Fatigue Severity Scale (KFSS)", 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation This is a short questionnaire of 9 questions to which the patient responds on a Likert scale ranging from 1 to 7'}, {'measure': 'change cognitive impairment by Trail Making Test A & B', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy.'}, {'measure': 'change Oximetry', 'timeFrame': 'every year during 5 years', 'description': 'composite predictive factors of alveolar hypoventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Apnea Syndrome', 'Muscular Diseases', 'non invasive ventilation', 'Diaphragmatic Disorder'], 'conditions': ['Myotonic Dystrophy, Steinert']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the factors associated with alveolar hypoventilation in terms of cognitive impairment, daytime sleepiness, respiratory function, nocturnal respiratory events This evaluation will clarify the clinical phenotypes of respiratory disease in myotonic steinert dystrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with a myotonic dystrophy of Steinert who consults in pneumology and who will have Respiratory functional exploration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myotonic dystrophy of Steinert genetically confirmed (number of known CTG repeats), in its classical form of adult\n\nExclusion Criteria:\n\n* Inability to perform EFR assessment or polysomnography\n* Moderate to severe asthma according to the GINA classification\n* moderate to severe COPD (\\> stage 1 of the GOLD recommendations)\n* Other significant respiratory pathology\n* Patient already on NIV, CPAP or under oxygen therapy\n* Impossibility of receiving enlightened information\n* Inability to participate in the entire study'}, 'identificationModule': {'nctId': 'NCT03764150', 'acronym': 'Steinert', 'briefTitle': 'Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Factors Associated With Hypoventilation in the Myotonic Dystrophy, Progressive Profile Over 5 Years', 'orgStudyIdInfo': {'id': '2009_04/0923'}, 'secondaryIdInfos': [{'id': '2009-A00588-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'PaCO2> 45 mmHg', 'description': 'Diurnal hypercapnia defined by PaCO2\\> 45 mmHg'}, {'label': 'PaCO2 <45 mmHg', 'description': 'PaCO2 diurnal within the limits of normal (PaCO2 \\<45 mmHg)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': "Centre Hospitalier Regional D' Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Garches', 'country': 'France', 'facility': 'Ap-Hp Hu Paris Site Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Calmette, CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Chu Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Chu de Nantes :Site Hôtel-Dieu- Hme - Nantes 1', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'facility': 'Ap-Hp Hu Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Thierry Perez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}