Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt (IMMERSION)

Head down tilt (HDT) was widely used to simulate microgravity effects on cardiovascular system. HDT could be a suitable model of water immersion (WI) which is also used to simulate the cardiovascular effects of microgravity and which is not easy to study in laboratory. To define the possibility to simulate immersion by HDT, a comparison between these models is required. A comparison between WI and few angles during HDT seems necessary to understand which angle is more adapt.

The immersion induces an increase of the central blood volume. This increase is caused by a redistribution of blood from peripheral portions of the body to the intrathoracic circulation. It seems to load cardiopulmonary and arterial baroreceptors. These baroreceptors bring into play autonomic nervous system (ANS) activation and induce a bradycardia.

HDT induces an increase in central blood volume as supported by the central venous pressure and cardiac volume increase and in return, MSNA and heart rate decrease. These cardiovascular effects seem to be the same as the thermoneutral immersion and suggest that the ANS activation is the same during HDT and WI.

Nevertheless, a few previous studies about ANS in HDT indicate some discordant results: a sympathetic decrease was reported but several results show an increase of parasympathetic activity linked with a trend of increase of arterial baroreflex. The aim of this study is to assess ANS activity in HDT on different angles (-6° and -15°) and WI. The investigators suppose an increase of parasympathetic activity during WI corresponding to parasympathetic activation during HDT especially at -6°.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

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

      • Saint-Etienne, France, 42055
        • CENTRE HOSPITALIER DE SAINT-ETIENNE

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Sportsman
  • None coffee, alcohol, cigarettes 6 hours before the start of each visit
  • Each meal must have been taken 4 hours before each visit
  • No intensive sport 48 hours before ech visit
  • Written inform consent

Exclusion Criteria:

  • Subject with cardiovascular,renal disease or with metabolic syndrome
  • Subject with medication
  • Subject who participated to an other medical research

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
heart rate variability
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure variability
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks
Spontaneous baroreflex activity
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks
Pulmonary diffusion
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks
Upper limbs vascular resistance
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks
post ischemic forearm hyperemia
Time Frame: inclusion, one week, two weeks
inclusion, one week, two weeks
Hematocrit rate
Time Frame: Inclusion, one week, two weeks
Inclusion, one week, two weeks
Cardiac haemodynamic
Time Frame: Inclusion, one week, two weeks
Inclusion, one week, two weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Frédéric Roche, MD PhD, CENTRE HOSPITALIER DE SAINT-ETIENNE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

April 1, 2008

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (ESTIMATE)

August 14, 2007

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 0708061
  • 2007-A00727-46 (OTHER: AFSSAPS)

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

Clinical Trials on Head-down tilt and immersion

Subscribe