- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515645
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Saint-Etienne, France, 42055
- CENTRE HOSPITALIER DE SAINT-ETIENNE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Frédéric Roche, MD PhD, CENTRE HOSPITALIER DE SAINT-ETIENNE
Publications and helpful links
General Publications
- Gabrielsen A, Johansen LB, Norsk P. Central cardiovascular pressures during graded water immersion in humans. J Appl Physiol (1985). 1993 Aug;75(2):581-5. doi: 10.1152/jappl.1993.75.2.581.
- Shiraishi M, Schou M, Gybel M, Christensen NJ, Norsk P. Comparison of acute cardiovascular responses to water immersion and head-down tilt in humans. J Appl Physiol (1985). 2002 Jan;92(1):264-8. doi: 10.1152/jappl.2002.92.1.264.
- Ueno LM, Miyachi M, Matsui T, Takahashi K, Yamazaki K, Hayashi K, Onodera S, Moritani T. Effect of aging on carotid artery stiffness and baroreflex sensitivity during head-out water immersion in man. Braz J Med Biol Res. 2005 Apr;38(4):629-37. doi: 10.1590/s0100-879x2005000400018. Epub 2005 Apr 13.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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.
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