Interaction of Otolith Stimulation and Carotid Baroreflex in Humans (OTOBAR)

September 30, 2015 updated by: University Hospital, Caen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • Laboratoire de Physiologie, CHU de Caen
        • Contact:
          • Hervé Normand
          • Phone Number: 02.31.06.45.31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • who participated in a clinical trial within less than the period of exclusion from this project
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Carotid Baroreflex measurements
Procedure: Stimulation of the carotid baroreceptors with a pressure system
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial flow in Common Carotid Artery (EchoDoppler)
Time Frame: baseline
Measurements of Common Carotid Artery Blood Flow in Cm/s
baseline
Arterial flow in Internal Carotid Artery (EchoDoppler)
Time Frame: Baseline
Measurements of Internal Carotid Artery Blood Flow in Cm/s
Baseline
Arterial flow in External Carotid Artery (EchoDoppler)
Time Frame: Baseline
Measurements of External Carotid Artery Blood Flow in Cm/s
Baseline
Arterial flow in Vertebral Artery (EchoDoppler)
Time Frame: Baseline
Measurements of Vertebral Artery Blood Flow in Cm/s
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 08-128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on Stimulation of the carotid baroreceptors with a pressure system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe