Cardiac Autonomic Functions During Head-out Immersion and... | NCT00515645

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

NCT00515645

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

May 11, 2020Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Head-down tilt and immersion

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-A00727-46	Other Identifier	AFSSAPS

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2020

Last Update Posted Date

May 11, 2020Actual

Name	Class
Ministry of Health, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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°.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Other: Head-down tilt and immersion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure variability		inclusion, one week, two weeks
Spontaneous baroreflex activity		inclusion, one week, two weeks
Pulmonary diffusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frédéric Roche, MD PhD	Centre Hospitalier de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Saint-Etienne		Saint-Etienne		42055	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8226455	Background	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.
11744669	Background	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.

ID	Term
D018475	Head-Down Tilt
D007101	Immersion

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena
D008919	Investigative Techniques