Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-13 @ 9:29 PM
Study NCT ID:
NCT02565095
Status:
UNKNOWN
Last Update Posted:
2015-10-01
First Post:
2015-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'lastUpdateSubmitDate': '2015-09-30', 'studyFirstSubmitDate': '2015-08-10', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arterial flow in Common Carotid Artery (EchoDoppler)', 'timeFrame': 'baseline', 'description': 'Measurements of Common Carotid Artery Blood Flow in Cm/s'}, {'measure': 'Arterial flow in Internal Carotid Artery (EchoDoppler)', 'timeFrame': 'Baseline', 'description': 'Measurements of Internal Carotid Artery Blood Flow in Cm/s'}, {'measure': 'Arterial flow in External Carotid Artery (EchoDoppler)', 'timeFrame': 'Baseline', 'description': 'Measurements of External Carotid Artery Blood Flow in Cm/s'}, {'measure': 'Arterial flow in Vertebral Artery (EchoDoppler)', 'timeFrame': 'Baseline', 'description': 'Measurements of Vertebral Artery Blood Flow in Cm/s'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'It is well documented that a few days stay in space induces a change in the vestibular-ocular reflex reflecting a reinterpretation of sensory inputs following the disappearance of gravity. If the change of eye reflexes actually the result of a reinterpretation of sensory input, the investigators should also expect to see an alteration of the vestibular-cardiovascular reflexes. The modification of these reflexes may modulate the carotid baroreflex and thus participate in the post-flight cardiovascular deconditioning.\n\nThe first objective of this project is to study the carotid baroreflex under different supine (dorsal, ventral and lateral) inducing different otolith stimulation in normal-gravity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers, male and / or female aged 18-30 years\n* subject affiliated to a social security scheme, agreeing to participate in the study and who provided informed consent.\n\nExclusion Criteria:\n\n* who participated in a clinical trial within less than the period of exclusion from this project\n* with a past or present history of heart disease, vascular, neurological, respiratory, rheumatological, metabolic or otologic.\n* pregnant women (dosage beta HCG)\n* having taken any medication heart, vascular, neurological, respiratory, rheumatological, metabolic or might interfere on vestibular test results during the two years preceding the experiment.\n* smoking or smoking more than 5 cigarettes / day, 1 cigarette / day or 1 pipe / day'}, 'identificationModule': {'nctId': 'NCT02565095', 'acronym': 'OTOBAR', 'briefTitle': 'Interaction of Otolith Stimulation and Carotid Baroreflex in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Interaction of Otolith Stimulation and Carotid Baroreflex in Humans', 'orgStudyIdInfo': {'id': '08-128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Carotid Baroreflex measurements', 'interventionNames': ['Procedure: Stimulation of the carotid baroreceptors with a pressure system']}], 'interventions': [{'name': 'Stimulation of the carotid baroreceptors with a pressure system', 'type': 'PROCEDURE', 'description': 'In each decubitus, trains of stimuli 8 (-80, -60, -40, -20, 0, 10, 20 and 40 Torr), with a duration of 500 milliseconds each, will be applied using a positive and negative pressure system placed around the neck of the subject.', 'armGroupLabels': ['Carotid Baroreflex measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Hervé Normand', 'role': 'CONTACT', 'phone': '02.31.06.45.31'}], 'facility': 'Laboratoire de Physiologie, CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}