Interaction of Otolith Stimulation and Carotid Baroreflex in Humans
OTOBAR
1 other identifier
interventional
54
1 country
1
Brief Summary
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. The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 10, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedOctober 1, 2015
September 1, 2015
7.8 years
August 10, 2015
September 30, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Arterial flow in Common Carotid Artery (EchoDoppler)
Measurements of Common Carotid Artery Blood Flow in Cm/s
baseline
Arterial flow in Internal Carotid Artery (EchoDoppler)
Measurements of Internal Carotid Artery Blood Flow in Cm/s
Baseline
Arterial flow in External Carotid Artery (EchoDoppler)
Measurements of External Carotid Artery Blood Flow in Cm/s
Baseline
Arterial flow in Vertebral Artery (EchoDoppler)
Measurements of Vertebral Artery Blood Flow in Cm/s
Baseline
Study Arms (1)
Carotid Baroreflex measurements
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Healthy volunteers, male and / or female aged 18-30 years
- subject affiliated to a social security scheme, agreeing to participate in the study and who provided informed consent.
You may not qualify if:
- with a past or present history of heart disease, vascular, neurological, respiratory, rheumatological, metabolic or otologic.
- pregnant women (dosage beta HCG)
- having taken any medication heart, vascular, neurological, respiratory, rheumatological, metabolic or might interfere on vestibular test results during the two years preceding the experiment.
- smoking or smoking more than 5 cigarettes / day, 1 cigarette / day or 1 pipe / day
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratoire de Physiologie, CHU de Caen
Caen, 14000, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2015
First Posted
October 1, 2015
Study Start
March 1, 2009
Primary Completion
December 1, 2016
Last Updated
October 1, 2015
Record last verified: 2015-09