Interaction of Otolith Stimulation and Carotid Baroreflex in Humans

Healthy Volunteers Clinical Trial

— OTOBAR  

Official title:

Interaction of Otolith Stimulation and Carotid Baroreflex in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565095
• Other study ID #: 08-128
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2015
• Last updated: September 30, 2015
• Start date: March 2009

Study information

• Verified date: September 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	Laboratoire de Physiologie, CHU de Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial flow in Common Carotid Artery (EchoDoppler)	Measurements of Common Carotid Artery Blood Flow in Cm/s	baseline	No
Primary	Arterial flow in Internal Carotid Artery (EchoDoppler)	Measurements of Internal Carotid Artery Blood Flow in Cm/s	Baseline	No
Primary	Arterial flow in External Carotid Artery (EchoDoppler)	Measurements of External Carotid Artery Blood Flow in Cm/s	Baseline	No
Primary	Arterial flow in Vertebral Artery (EchoDoppler)	Measurements of Vertebral Artery Blood Flow in Cm/s	Baseline	No