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Completed

NCT Number: NCT00515645

Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt

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°.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head-down tilt and immersion

Other

Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two

Primary outcomes

  1. heart rate variability

    Time frame: inclusion, one week, two weeks

Secondary outcomes

  1. Blood pressure variability

    Time frame: inclusion, one week, two weeks

  2. Spontaneous baroreflex activity

    Time frame: inclusion, one week, two weeks

  3. Pulmonary diffusion

    Time frame: inclusion, one week, two weeks

  4. Upper limbs vascular resistance

    Time frame: inclusion, one week, two weeks

  5. post ischemic forearm hyperemia

    Time frame: inclusion, one week, two weeks

  6. Hematocrit rate

    Time frame: Inclusion, one week, two weeks

  7. Cardiac haemodynamic

    Time frame: Inclusion, one week, two weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Acronym: IMMERSION

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 14, 2007
Registry last updated
May 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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