Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-01 @ 7:50 PM
Study NCT ID:
NCT03903666
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2019-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Down syndrome patients aged from 4 to 16 years'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2019-03-23', 'studyFirstSubmitQcDate': '2019-04-03', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with high mean PtcCO2 as assessed by nocturnal gas exchange recordings', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of total sleep time with a PtcCO2 in mmHg higher than 50; mean, maximum and minimum SpO2 in %', 'timeFrame': '2 months'}, {'measure': 'Number of patients with low mean, minimum and maximum SpO2 (oyxygen saturation) and/or % of Total sleep time spent with a PtcCO2 higher than 50 mmHg, higher than 20%, as measured by nocturnal gas exchange recordings.', 'timeFrame': '2 months'}, {'measure': 'Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders assed by the Dysautonomia questionnaire', 'timeFrame': '2 months'}, {'measure': 'Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by Hand Grip assessment', 'timeFrame': '2 months'}, {'measure': 'Correlation between nocturnal PtcCO2 value and the existence of executive function and behavioral disorders measured by OSA (Obstructive Sleep Apnea) assessment questionnaire', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Apnoa', 'Down Syndrome', 'Children', 'OSA'], 'conditions': ['Down Syndrome']}, 'referencesModule': {'references': [{'pmid': '23121137', 'type': 'BACKGROUND', 'citation': 'Feldman JL, Del Negro CA, Gray PA. Understanding the rhythm of breathing: so near, yet so far. Annu Rev Physiol. 2013;75:423-52. doi: 10.1146/annurev-physiol-040510-130049. Epub 2012 Oct 29.'}, {'pmid': '25928806', 'type': 'BACKGROUND', 'citation': 'Trang H, Brunet JF, Rohrer H, Gallego J, Amiel J, Bachetti T, Fischbeck KH, Similowski T, Straus C, Ceccherini I, Weese-Mayer DE, Frerick M, Bieganowska K, Middleton L, Morandi F, Ottonello G; European Central Hypoventilation Syndrome Consortium. Proceedings of the fourth international conference on central hypoventilation. Orphanet J Rare Dis. 2014 Dec 5;9:194. doi: 10.1186/s13023-014-0194-5.'}, {'pmid': '16924359', 'type': 'BACKGROUND', 'citation': 'Ng DK, Hui HN, Chan CH, Kwok KL, Chow PY, Cheung JM, Leung SY. Obstructive sleep apnoea in children with Down syndrome. Singapore Med J. 2006 Sep;47(9):774-9.'}]}, 'descriptionModule': {'briefSummary': 'Recently, retrospective studies have shown that Down Syndrome children have a higher CO2 (carbone dioxide) sleep pressure than the general pediatric population. This increase does not seem to be always related to sleep apnea. The Investigators wish to confirm these results prospectively. The investigators hypothesize that this alveolar hypoventilation may be due to ventilatory control disorders caused by dysautonomia, but also to a decrease in the strength of the respiratory muscles within the framework of the global muscular hypotonia described in children with Down syndrome. .', 'detailedDescription': '47 Down syndrome patients age from 4 to 16 will be included. They will perform a medical visit at J0, then a measurement of gaz nocturnal exchanges at home within 1 month'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Down syndrome patient without mosaicism\n* Age 4 to 16 years\n* Predominant French language in the living environment\n\nExclusion Criteria:\n\n* OAS diagnostic focused on an earlier polysomnography\n* Methylphenidate treatment started before inclusion'}, 'identificationModule': {'nctId': 'NCT03903666', 'briefTitle': 'Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jerome Lejeune'}, 'officialTitle': 'Anomalies of Nocturnal Gaz Exchanges in Patients With Down Syndrome Aged From 4 to 16 Years', 'orgStudyIdInfo': {'id': 'TriRespi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort', 'description': '47 Down syndrome patients age from 4 to 16', 'interventionNames': ['Other: Nocturnal gaz exchanges measurement']}], 'interventions': [{'name': 'Nocturnal gaz exchanges measurement', 'type': 'OTHER', 'description': "Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment", 'armGroupLabels': ['Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'TAYTARD MD Jessica', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Armand Trousseau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jerome Lejeune', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital Armand Trousseau', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}