Thigh Cuffs to Prevent the Deconditioning Induced by 5 Days of Dry Immersion

NCT03915457 | Completed

• 1 other identifier: 18-179
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to investigate whether thigh cuffs help to prevent and/or reduce the deconditioning induced by 5 days of dry immersion and in particular the fluid shift and its related ophthalmological disorders. During a randomized 5 day dry-immersion study in 20 healthy male adults the two following aims will be undertaken:

• Ten scientific protocols will assess the changes in the cerebral, ocular, cardiovascular, metabolism, cognitive, muscle and bone systems.
• In the above mentioned systems, the potential beneficial effects of the countermeasure protocol will also be investigated.

Conditions

Weightlessness; Weightlessness; Adverse Effect

Keywords

Simulated Microgravity; Weightlessness; Countermeasure; Dry immersion; Supportlessness

Outcome Measures

Primary Outcomes (1)

• Change in optic nerve sheath diameter (ONSD) considered as an indirect marker for intracranial pressure (ICP) estimation

  The optic nerve sheath diameter (ONSD) variations will be measured by echography.

  Baseline and five days of dry-immersion

Secondary Outcomes (15)

• Change in the optic nerve fibers thickness

  Baseline and five days of dry-immersion

• Change in cerebral structures and in venous circulation of the brain by MRI

  Baseline and five days of dry-immersion

• Change in cerebral perfusion

  Baseline and five days of dry-immersion

• Change in intraocular pressure.

  Baseline and five days of dry-immersion

• Change in orthostatic tolerance

  Baseline and five days of dry-immersion

Other Outcomes (4)

• Change in gut microbiota

  Baseline, during and after 5 days of dry-immersion

• Change in iron metabolism

  Baseline, during and after 5 days of dry-immersion

• Change in the contribution of visual and vestibular information used while performing mental transformations during a perspective-taking task.

  Baseline, during and after 5 days of dry-immersion

Study Arms (2)

Dry immersion Control Group

EXPERIMENTAL

5 days of dry-immersion

Other: Dry immersion Control Group

Thigh Cuffs intervention

EXPERIMENTAL

5 days of dry-immersion with thigh cuffs

Other: Thigh cuffs intervention

Interventions

Dry immersion Control Group OTHER

Subjects are immersed up to the neck for 5 days in a specially designed bath filled with tap water.

Dry immersion Control Group

Thigh cuffs intervention OTHER

Subjects are immersed up to the neck for 5 days in a specially designed bath filled with tap water. During the 5 days of dry immersion, the subjects will wear the thigh cuffs daily for 10 hours during the day (8 am to 6 pm). Thigh cuffs are strips of fabric with inserts of elastic fabric. Different sizes exist to adapt to different thighs. Each cuff has five tightening positions (from 1 to 5) and they will be tightened at the upper third of the thighs to create an occlusion pressure of about 30 mmHg.

Thigh Cuffs intervention

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteer (see below the description of medical tests and laboratory analysis performed at the selection visit),
• Age 20 to 45,
• No overweight nor excessive thinness with BMI (weight Kg/ height m2) between 20 and 26,
• Height between 158 and 185 cm,
• No personal nor family past record of chronic or acute disease or psychological disturbances which could affect the physiological data and/or create a risk for the subject during the experiment,
• Fitness level assessment:
• if age \< 35 years: 35 ml/min/kg \< VO2max \< 60ml/min/kg
• if age \> 35 years: 30 ml/min/kg \< VO2max \< 60ml/min/kg
• Walking between 7000 - 8000 steps/day,
• Active and free from any orthopedic (in particular no vertebral fracture, scoliosis or herniated disc) musculoskeletal and cardiovascular disorders,
• Non smokers,
• No alcohol, no drug dependence and no medical treatment,
• No antibiotic treatment in the 2 previous months before the beginning of the study,
• Covered by a Social Security system,
• Have signed the information consent,

You may not qualify if:

• \- Past record of orthostatic intolerance,
• Cardiac rhythm disorders,
• Chronic back pains,
• Vertebral fracture, scoliosis or herniated disc,
• Glaucoma,
• HTA,
• History of migraines,
• History of hiatus hernia or gastro-esophageal reflux,
• History of thyroid dysfunction, renal stones, diabetes,
• History of head trauma,
• Past records of thrombophlebitis, family history of thrombosis or positive response in thrombosis screening procedure (anti thrombin III, S-protein, C-protein, factor V Leiden mutation and the mutation 20210 of the prothrombin gene),
• Individuals exhibiting mutations involved in hereditary hemochromatosis (HAMP, HFE, HFE2, SCL40A1 and TRF2),
• Abnormal result for lower limbs echo-doppler,
• History or active claustrophobia,
• History of genetic muscle and bone diseases of any kind,

Sponsors & Collaborators

• Centre National d'Etudes Spatiales: lead

Study Sites (1)

Medes-Imps

Toulouse, 31400, France

Location

Related Publications (5)

• Arbeille P, Herault S, Fomina G, Roumy J, Alferova I, Gharib C. Influences of thigh cuffs on the cardiovascular system during 7-day head-down bed rest. J Appl Physiol (1985). 1999 Dec;87(6):2168-76. doi: 10.1152/jappl.1999.87.6.2168.

  PMID: 10601164 BACKGROUND

• Balasubramanian S, Tepelus T, Stenger MB, Lee SMC, Laurie SS, Liu JHK, Feiveson AH, Sadda SR, Huang AS, Macias BR. Thigh Cuffs as a Countermeasure for Ocular Changes in Simulated Weightlessness. Ophthalmology. 2018 Mar;125(3):459-460. doi: 10.1016/j.ophtha.2017.10.023. Epub 2017 Nov 16. No abstract available.

  PMID: 29153458 BACKGROUND

• De Abreu S, Amirova L, Murphy R, Wallace R, Twomey L, Gauquelin-Koch G, Raverot V, Larcher F, Custaud MA, Navasiolava N. Multi-System Deconditioning in 3-Day Dry Immersion without Daily Raise. Front Physiol. 2017 Oct 13;8:799. doi: 10.3389/fphys.2017.00799. eCollection 2017.

  PMID: 29081752 BACKGROUND

• Kermorgant M, Leca F, Nasr N, Custaud MA, Geeraerts T, Czosnyka M, Arvanitis DN, Senard JM, Pavy-Le Traon A. Impacts of Simulated Weightlessness by Dry Immersion on Optic Nerve Sheath Diameter and Cerebral Autoregulation. Front Physiol. 2017 Oct 12;8:780. doi: 10.3389/fphys.2017.00780. eCollection 2017.

  PMID: 29075198 BACKGROUND

• Navasiolava NM, Custaud MA, Tomilovskaya ES, Larina IM, Mano T, Gauquelin-Koch G, Gharib C, Kozlovskaya IB. Long-term dry immersion: review and prospects. Eur J Appl Physiol. 2011 Jul;111(7):1235-60. doi: 10.1007/s00421-010-1750-x. Epub 2010 Dec 14.

  PMID: 21161267 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A monocentric open parallel randomized and controlled study.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 16, 2019
• Study Start: November 18, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 23, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)