Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 3:28 PM
Study NCT ID:
NCT05000151
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2021-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536196', 'term': 'Ehlers-Danlos syndrome type 3'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-08-07', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of lung volume perception', 'timeFrame': 'Baseline', 'description': 'The perception of lung volume is assessed using a device comprising a flow meter, an electronic acquisition card and an LCD screen. Subjects will be given 3 trials to train to perceive a target lung volume and then 3 trials without feedback to reproduce that target lung volume. The mean of the absolute deviations from the target volumes in percent is used as the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Minute ventilation with or without cognitive task', 'timeFrame': 'Baseline', 'description': 'The minute ventilation will be calculated over 1 minute without cognitive task and then over 1 minute with cognitive task (trail making test part B).'}, {'measure': 'Respiratory rate variability', 'timeFrame': 'Baseline', 'description': 'The time interval between each inspiratory peak will be recorded and will allow the calculation of the standard deviation and the root mean square with and without the cognitive task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypermobile Ehlers-Danlos Syndrome']}, 'referencesModule': {'references': [{'pmid': '38582758', 'type': 'DERIVED', 'citation': 'Hakimi A, Bergoin C, De Jesus A, Hermand E, Fabre C, Mucci P. Impairment of lung volume perception and breathing control in hypermobile Ehlers-Danlos syndrome. Sci Rep. 2024 Apr 6;14(1):8119. doi: 10.1038/s41598-024-58890-2.'}]}, 'descriptionModule': {'briefSummary': 'Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited through practitioners working with the clinic, who will propose participation in the study during consultations with patients diagnosed with EDS.\n\nThe recruitment of subjects for the control group will be carried out by internal communication within the Clinique de la Mitterie on a voluntary basis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (common):\n\n* More than 18 years old\n* Understanding French\n\nInclusion Criteria (hEDS Patients):\n\n* hEDS diagnosis\n\nInclusion Criteria (healthy subjects):\n\n* Age (±5 years), Gender and BMI (±2.5kg/m²) matching\n\nExclusion Criteria (common):\n\n* Pregnancy\n\nExclusion Criteria (hEDS Patients):\n\n* Respiratory comorbidity independent of hEDS\n* Previous participation in a rehabilitation programme at the clinic\n\nExclusion Criteria (healthy subjects):\n\n* Known respiratory or proprioceptive pathology\n* Hypermobility (evaluated with the Beighton score)'}, 'identificationModule': {'nctId': 'NCT05000151', 'acronym': 'ProprioRespi', 'briefTitle': 'Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Clinique de la Mitterie'}, 'officialTitle': 'Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.', 'orgStudyIdInfo': {'id': 'ProprioRespi'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Hypermobile Ehlers-Danlos patients (n=21)'}, {'label': 'Healthy subjects', 'description': "Healthy subjects recruited from the clinic's staff (n=21) Age, Gender and BMI matched with hEDS patients"}]}, 'contactsLocationsModule': {'locations': [{'zip': '59160', 'city': 'Lomme', 'country': 'France', 'facility': 'Clinique de la Mitterie', 'geoPoint': {'lat': 50.64358, 'lon': 2.98715}}], 'overallOfficials': [{'name': 'Cyrille Bergoin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique de la Mitterie'}, {'name': 'Patrick Mucci, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UREPSSS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hakimi Adrien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MCs, PT', 'investigatorFullName': 'Hakimi Adrien', 'investigatorAffiliation': 'Clinique de la Mitterie'}}}}