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

NCT03915457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-08-21

No results posted yet for this study

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

Interventions

OTHER

Dry immersion Control Group

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

OTHER

Thigh cuffs intervention

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.

Sponsors & Collaborators

  • Centre National d'Etudes Spatiales

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-18
Primary Completion
2019-03-22
Completion
2019-03-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03915457 on ClinicalTrials.gov