CompletedNot Applicable

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

France20 participantsStarted 2018-11-18

Plain-language 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.

Who can participate

Age range

20 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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, * Free of any engagement during the study. Exclusion Criteria: * \- 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, fa…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and five days of dry-immersion

Trial details

NCT IDNCT03915457

SponsorCentre National d'Etudes Spatiales

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-03-22

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