Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-04-18 @ 10:59 AM
Study NCT ID:
NCT02356666
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2014-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2014-12-17', 'studyFirstSubmitQcDate': '2015-02-04', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in the prevalence of nocturnal hypoventilation according to different previously proposed definitions', 'timeFrame': 'Baseline (Day 1)', 'description': 'The prevalence of nocturnal hypoventilation (percentage of patients diagnosed as having hypoventilation over the total population) according to the different definition available in the literature will be described'}], 'secondaryOutcomes': [{'measure': 'Concordance between the diagnostic criteria', 'timeFrame': 'Baseline (Day 1)', 'description': 'Concordance between the different diagnostic criteria of hypoventilation'}, {'measure': 'sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)', 'timeFrame': 'Baseine (Day 1)', 'description': 'sensibility/specificity of the different criteria to identify daytime alveolar hypoventilation (defined on blood gas analysis)'}, {'measure': 'Prognostic value of the different definitions of nocturnal hypoventilation', 'timeFrame': '5 years', 'description': 'The ability of the examined definition to predict the need for mechanical ventilation will be investigated, defined as appearance of daytime hypercapnia or beginning of mechanical ventilation and/or mortality.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuromuscular Disease']}, 'descriptionModule': {'briefSummary': "Different definitions of nocturnal hypoventilation are used in the recent literature. The investigators aimed to compare the prevalence of nocturnal hypoventilation in a neuromuscular disease's population according to different definitions issued from the literature.", 'detailedDescription': "Different definitions of nocturnal hypoventilation are used in the recent literature. Basing on retrospective data review, we aimed to compare the prevalence of nocturnal hypoventilation in the cohort of neuromuscular disease's patients followed at our reference center, according to different definitions issued from the literature."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neuromuscular disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neuromuscular disease\n* Age ≥18 years\n* Non mechanically ventilated\n\nExclusion Criteria:\n\n* Long-term oxygen therapy'}, 'identificationModule': {'nctId': 'NCT02356666', 'acronym': 'TcCO2', 'briefTitle': 'Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions', 'organization': {'class': 'OTHER', 'fullName': "Centre d'Investigation Clinique et Technologique 805"}, 'officialTitle': 'Prevalence of Nocturnal Hypoventilation in Neuromuscular Diseases According to Different Definitions', 'orgStudyIdInfo': {'id': '1817118'}}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'state': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Adam Ogna, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre d'Investigation Clinique et Technologique 805", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}