HealthyIMMERSIONNCT00515645
Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt
A study testing Head-down tilt and immersion in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Head-down tilt and immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Subject with cardiovascular,renal disease or with metabolic syndrome
- Subject with medication
- Subject who participated to an other medical research
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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°.
- Conditions
- Healthy
- Being tested
- Head-down tilt and immersion
- Keywords
- Autonomic nervous system, Immersion, Heart rate variability, Head-down tilt, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-down tilt and immersionOther
Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Head-down tilt and immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate variability
Measured: inclusion, one week, two weeks
Secondary outcomes (7)
Blood pressure variability
Measured: inclusion, one week, two weeks
Spontaneous baroreflex activity
Measured: inclusion, one week, two weeks
Pulmonary diffusion
Measured: inclusion, one week, two weeks
Upper limbs vascular resistance
Measured: inclusion, one week, two weeks
post ischemic forearm hyperemia
Measured: inclusion, one week, two weeks
Hematocrit rate
Measured: Inclusion, one week, two weeks
Cardiac haemodynamic
Measured: Inclusion, one week, two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Frédéric Roche, MD PhD, Principal investigator, Centre Hospitalier de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515645
- Sponsor's protocol ID
- 0708061
- Other IDs
- 2007-A00727-46
- Acronym
- IMMERSION
- Status last verified
- May 2020
- First submitted
- 13 Aug 2007
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 8226455Shiraishi 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.
PubMed 11744669Ueno 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.
PubMed 15962190
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt
- ClinicalTrials.gov ID
- NCT00515645
- Acronym / sponsor ID
- IMMERSION / 0708061
- Conditions
- Healthy
- Keywords
- Autonomic nervous system, Immersion, Heart rate variability, Head-down tilt, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Head-down tilt and immersion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Subject with cardiovascular,renal disease or with metabolic syndrome
- Subject with medication
- Subject who participated to an other medical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-down tilt and immersionHead-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two | Other | 1 |
Primary outcome
heart rate variability
Time frame: inclusion, one week, two weeks
7 secondary outcomes
Blood pressure variability
Time frame: inclusion, one week, two weeks
Spontaneous baroreflex activity
Time frame: inclusion, one week, two weeks
Pulmonary diffusion
Time frame: inclusion, one week, two weeks
Upper limbs vascular resistance
Time frame: inclusion, one week, two weeks
post ischemic forearm hyperemia
Time frame: inclusion, one week, two weeks
Hematocrit rate
Time frame: Inclusion, one week, two weeks
Cardiac haemodynamic
Time frame: Inclusion, one week, two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Background: PubMed 8226455Gabrielsen 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.
- Background: PubMed 11744669Shiraishi 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.
- Background: PubMed 15962190Ueno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Roche, MD PhD principal investigator
Centre Hospitalier de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-down tilt and immersion in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: inclusion, one week, two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515645, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.