A 5-day Dry Immersion Study on 20 Healthy Male Volunteers

NCT05493176 | Completed

• 2 other identifiers: 22-2822022-A00881-42
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Dry immersion (DI) is a ground-based model of prolonged conditions of simulated microgravity. Dry immersion involves immersing the subject in water covered with an elastic waterproof fabric. As a result, the immersed subject, who is freely suspended in the water mass, remains dry. Within a relatively short duration, the model can faithfully reproduce most physiological effects of actual microgravity, including centralization of body fluids, support unloading, and hypokinesia. The main objective of the present study is to investigate the physiological effects of 5 days of dry immersion in 20 healthy male subjects, and to obtain DI-in-Men Reference Dataset. A set of measurements will assess the changes in the cardiovascular, neuro-ophthalmological, hematological, metabolic, sensorimotor, immune, muscle and bone systems.

Conditions

Weightlessness

Keywords

Microgravity simulation; Models; Weightlessness

Outcome Measures

Primary Outcomes (47)

• Change in orthostatic tolerance

  Orthostatic tolerance will be assessed during a Lower Body Negative Pressure test (LBNP test)

  At baseline and five days of 5 days of dry immersion

• Change in peak aerobic power (VO2max test)

  Exercise capacity wil be assessed by graded cycling on sitting ergometer until exhaustion

  At baseline and the first day of recovery

• Change in plasma volume

  Plasma volume (L) will be assessed by the carbon monoxide-rebreathing method

  At baseline and five days of dry immersion

• Change in fluid shift distribution towards the cardiac and cephalic region

  The consequences of the fluid shift on the cardiac and cephalic area will be assessed by quantifying the right and left Jugular veins volumes (mL), as well as the left ventricle diastolic/systolic volumes (mL) by ultrasound.

  At baseline, the first day to quantify the short term effect and the fifth day of dry-immersion to quantify the long term effect of fluid shift

• Change in vascular endothelium integrity

  Vascular endothelium integrity will be assessed by blood parameters of vascular and endothelial integrity. Global change of endothelial state will be estimated using several biomarkers, including zonulin, cell adhesion molecules (E-selectin, L-selectin, CD146), growth factors (VEGF, VEGFR-1), glycocalyx breakdown products (syndecan-1, hyaluronic acid, heparan sulfate).

  At baseline and during the five days of the dry-immersion period

• Change in circadian rhythms of blood pressure

  Continuous 24-h recording of systolic and diastolic blood pressure will be performed by a Non Invasive Blood Pressure system (SOMNOtouch™NIBP) designed for ambulatory continuous measurements

  At baseline and during the five days of the dry-immersion period

• Change in lower limb veins functions

  Venous compliance of lower limbs will be assessed by plethysmography

  At baseline and four days of dry-immersion and one day of recovery

• Change in body fluid compartments by bioelectrical impedance analysis

  Extracellular, intracellular and total body water will be estimated by bioimpedance

  At baseline and during five days of dry-immersion

• Change in muscle strength

  Muscle strength will be assessed from single leg isometric maximal voluntary contraction on the knee extensors \& flexors, the plantarflexors and dorsiflexors. The Isometric Torque will be measured in Nm. The peak of the three maximal attempts will be recorded for strength measures

  Before dry immersion and after one day of recovery

• Change in muscle fatigue

  Muscle fatigability will be assessed during a submaximal isometric knee extension contraction held for 30 seconds at 50% of the baseline Maximal Voluntary Contraction (MVC) value

  Before dry immersion and after one day of recovery

• Change in muscle volume at calf level

  Muscle dehydration, eventual atrophy and fatty degeneration will be measured by quantitative Dixon MRI sequences at calf level

  At baseline and five days of dry-immersion

• Change in contraction time

  Contraction time will be assessed during a measurement using the tensiomyography method in the following muscles: vastus lateralis, Gastrocnemius medialis and Biceps femoris of dominant leg / arm.

  At baseline and five days of dry immersion

• Change in serum bone formation markers

  Change in bone-specific Alkaline Phosphatase (bAP, µg/L) and procollagen type I N-terminal propeptide (P1NP, µg/L) will be assessed by chemiluminescence immunoassay

  At baseline and during the 5 days of dry-immersion

• Change in serum bone resorption markers

  Change in C-terminal cross-linked telopeptide of type I collagen (CTx, pmol/L) and N-terminal cross-linked telopeptide of type I collagen (NTX, pmol/L) will be assessed by chemiluminescence immunoassay

  At baseline and during the 5 days of dry-immersion

• Change in serum cartilage synthesis biomarkers

  Change in serum CP II and in human cartilage glycoprotein-39 (YKL-40) concentrations

  At baseline and during the 5 days of dry-immersion

• Change in serum cartilage degradation biomarkers

  Change in serum Cartilage Oligomeric Matrix Protein (COMP) and fragments or propeptide of type II collagen (C2C, C1,2C, Coll-2-1) concentrations

  At baseline and during the 5 days of dry-immersion

• Change in urine cartilage degradation biomarkers

  Change in C-telopeptide of type II collagen (CTX-II) and nitrated form of peptide of the α-helical region of type II collagen (Coll-2-1NO2) concentrations

  At baseline and during the 5 days of dry-immersion

• Change in Resting Metabolic Rate (RMR)

  RMR will be measured by indirect calorimetry technique

  At baseline and 5 days of dry-immersion

• Change in nitrogen balance

  Nitrogen balance is a measure of nitrogen input minus nitrogen output. Nitrogen intake is calculated with a nutrition software. Protein oxidation measured in the 24-Hour urine collection estimates nitrogen output

  At baseline and 5 days of dry-immersion

• Change in fat and lean body mass measured by dual energy x-ray absorptiometry (DEXA)

  Dual energy x-ray absorptiometry is a standard clinical technique to assess fat (g) and lean (g) body mass.

  At baseline and 5 days of dry-immersion

• Change in glucose tolerance (Oral Glucose Tolerance Test)

  Glucose and insulin levels will be measured at baseline (fasting) and 30, 60, 90, and 120 minutes after drinking within 5 min a water solution containing 75 g of glucose

  At baseline and 5 days of dry-immersion

• Change in Core temperature

  Measured by electronic ingestible temperature capsules (e-Celsius Performance)

  At baseline and during the 5 days of dry immersion

• Change in height

  Measured in supine and standing position

  Before, during and after the 5 days of dry immersion

• Change in mid cerebral artery (MCA) blood flow velocity

  Transcranial Doppler measurements

  At baseline and 5 days of dry immersion

• Change in mood

  Change in mood is assessed using the Profile of Mood States (POMS) questionnaire. POMS questionnaire gives 6 measures of mood: 1. Tension/anxiety, 2. Depression, 3. Anger/hostility 4. Dynamism, 5. Fatigue, 6. Confusion A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales (tension, depression, fatigue, confusion, anger) and then subtracting the totals for the positive subscale (vigor /esteem-related affect).

  Before, during and after 5 days of dry-immersion

• Change in affective states

  Positive and Negative Schedule (PANAS) questionnaire will be used to assess the intensity of positive and negative affective states. PANAS self-report questionnaire consists of two 10-item scales to measure both positive and negative affects Each item is rated on a five-point Likert Scale, ranging from 1 = Not at all to 5 = Extremely, to measure the extent to which the affect has been experienced in a specified time frame. Positive affects: scores can range from 10 - 50 with higher scores representing higher levels of positive affect. Negative affects: scores can range from 10 - 50 with higher scores representing higher levels of negative affect.

  Before, during and after 5 days of dry-immersion

• Change in sleep quality

  Pittsburgh Sleep Dairy (PghSD) will be used to assess sleep perceived quality. The PghSD is an instrument with separate components to be completed at bedtime and waketime. The following parameters are registered or assessed: Bedtime, waketime, sleep latency, wake after sleep onset, total sleep time, mode of awakening and ratings of sleep quality, mood, and alertness on wakening, as well as daytime information on naps, exercise, meals and caffeine, tobacco and medications use.

  Before, during and after 5 days of dry-immersion

• Change in psychological state: mental health

  General Health Questionnaire-28 (GHQ-28) will be used to assess psychological well-being and capture distress GHQ-28 gives an overall total score and 4 scores for 4 subscales: * Somatic symptoms, * Anxiety/insomnia, * Social dysfunction, * Severe depression. Higher scores indicate higher levels of distress

  Before, during and after 5 days of dry-immersion

• Change in coping strategies

  Brief Cope Questionnaire is designed to measure effective and ineffective ways to cope with a stressful life event, and will be used to assess coping strategies. The Brief Cope is a shortened form (28 items) of the Carver and Scheier COPE inventory. There are 14 coping strategies. These strategies can be then gathered in two main categories : approach coping and avoidance coping.

  Before, during and after 5 days of dry-immersion

• Change in cerebral autoregulation

  Transcranial Doppler measurements of mid cerebral artery blood flow velocity will allow to determine cerebral autoregulation

  At baseline and 5 days of dry-immersion

• Change in Intra Cranial Pressure (ICP)

  ICP changes will be monitored through OtoAcoustic Emissions (OAE)

  At baseline, during and after 5 days of dry-immersion

• 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

  At baseline, during and after 5 days of dry-immersion

• Change in the optic nerve fibers thickness

  Thickness of the optic nerve fibers will be measured by Optical Coherence Tomography (OCT)

  At baseline and five days of dry-immersion

• Change in intraocular pressure (IOP)

  IOP measured by applanation

  At baseline, during and after five days of dry-immersion

• Change in visual acuity

  Far and near visual acuity are tested uncorrected, or if applicable with own correction with digital acuity system

  At baseline and five days of dry-immersion

• Change in visual field

  Visual field measured by standard automated perimetry

  At baseline and five days of dry-immersion

• Change in the anatomical characteristics of the eye (optical biometry)

  Optical biometry measured by partial coherence interferometry

  At baseline and five days of dry-immersion

• Change in the central corneal thickness

  Central corneal thickness on a single point on the cornea measured by Ultrasonic pachymetry

  At baseline and five days of dry-immersion

• Change in the retina by non-mydriatic fundus retinography

  Non-mydriatic fundus retinography allows a fundus photography to be taken and thus a color image of the papilla, retinal vessels and macula

  At baseline and five days of dry-immersion

• Change in the cornea topography

  Cornea topography measured by corneal topography equipment (like Pentacam). The elevation topography according to Scheimpflug principle allows the mapping of the anterior and posterior surface of the cornea.

  At baseline and five days of dry-immersion

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

  Visualization of cerebral structures and intracranial venous system will be performed by MRI coupled with injection of gadolinium

  At baseline and five days of dry-immersion

• Change in walking balance

  Walking balance will be assessed by Dynamic Gait Index, specific parameter is: total Score (range 0-24). Higher scores mean a better outcome

  At baseline and the first day of recovery

• Change in standing balance

  Standing balance will be assessed by posturography eyes open and eyes closed on a platform covered with 12-cm thick medium density foam

  At baseline and the first day of recovery

• Change in motion sickness susceptibility

  Assessed by the Motion Sickness Susceptibility Questionnaire Short form (MSSQ-Short). MSSQ-Short scores possible range from minimum 0 to maximum 54, the maximum being unlikely. Higher scores means a higher motion sickness susceptibility

  At baseline, during and after 5 days of dry immersion

• Change in thrombotic and fibrinolytic processes

  Thrombotic and fibrinolytic processes will be assessed by the following four coagulation values: i) plasma levels of tissue factor (TF), the physiological trigger for the coagulation cascade, by using the assay Actichrome Tissue factor ELISA from American Diagnostica (Pfungstadt, Germany); ii) Endogenous thrombin potential, an appropriate method to assess the coagulability of a given plasma sample, by using calibrated automated thrombography (CAT, Thrombinoscope BV, Maastricht, the Netherlands); iii) tissue-Plasminogen activator (tPA), by using the assay IMUBIND tPA ELISA kit from American Diagnostica (Pfungstadt, Germany); iv) thromboelastometry (TEM, coagulation analyzer from Matel Medizintechnik, Graz, Austria), providing a kinetic analysis of the clot formation process and of clot dissolution by the fibrinolytic system.

  Before, during and after 5 days of dry immersion

• Change in respiratory volumes

  Change in Forced vital capacity (FVC, L), Tidal Volume (TV, L), Inspiratory reserve Volume (IRV, L), Expiratory reserve volume (ERV, L) will be assessed using spirometry

  At baseline, the 1st day of dry immersion and following 5 days of dry immersion

• Change in respiratory flows

  Change in Forced expiratory volume in 1 second (FEV1, L/s) and in Peak expiratory flow (PEF, L/min), will be assessed using spirometry

  At baseline, the 1st day of dry immersion and following 5 days of dry immersion

Study Arms (1)

Dry immersion

EXPERIMENTAL

5 days of dry-immersion

Other: Dry immersion

Interventions

Dry immersion OTHER

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

Dry immersion

Eligibility Criteria

• Age: 20 Years - 40 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 40,
• No overweight nor excessive thinness with BMI (weight Kg/ height m2) between 20 and 26,
• Height between 158cm and 185 cm,
• Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination): in particular, free from any chronic disease or any acute infectious disease or cardiovascular, neurological, ear, nose, and throat (ENT) (especially orthostatic hypotension and vestibular disorders), orthopaedic or musculoskeletal disorders,
• Fitness level assessment: 35 ml/min./kg \< VO2max \< 55 ml/min./kg,
• Non active smokers,
• No alcohol, or drug addiction, and no medical treatment,
• Covered by a Health Insurance System,
• Having signed the informed consent,
• Free from any engagement during the study.

You may not qualify if:

• Any history or presence of clinically relevant cardiovascular, neurological or ENT (especially orthostatic hypotension and vestibular disorders), any chronic disease; any acute infectious disease, in particular
• Symptomatic orthostatic hypotension whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure (SBP) equal to or greater than 20 mmHg within 3 minutes when changing from the supine to the standing position,
• Cardiac rhythm disorders,
• Hypertension,
• Chronic back pains,
• Vertebral fracture, scoliosis or herniated disc,
• Glaucoma,
• Self-reported hearing problems,
• History of migraines,
• History of hiatus hernia or gastro-esophageal reflux,
• History of thyroid dysfunction, renal stones, diabetes,
• History of head trauma,
• History of genetic muscle and bone diseases of any kind,
• 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),
• Signs of venous insufficiency, varicose veins, or telangiectasia

Sponsors & Collaborators

• Centre National d'Etudes Spatiales: lead
• European Space Agency: collaborator

Study Sites (1)

Medes-Imps

Toulouse, 31400, France

Location

Related Publications (5)

• 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

• 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

• Linossier MT, Amirova LE, Thomas M, Normand M, Bareille MP, Gauquelin-Koch G, Beck A, Costes-Salon MC, Bonneau C, Gharib C, Custaud MA, Vico L. Effects of short-term dry immersion on bone remodeling markers, insulin and adipokines. PLoS One. 2017 Aug 14;12(8):e0182970. doi: 10.1371/journal.pone.0182970. eCollection 2017.

  PMID: 28806419 BACKGROUND

• Jacob P, Robin A, Navasiolava N, Custaud MA, Ghislin S, Bareille MP, De Villemeur RB, Antunes I, Van Ombergen A, Gauquelin-Koch G, Frippiat JP. ESA VIVALDI Dry Immersion Microgravity Simulations Induce Increases in Immune Biomarkers Associated With Physical and Psychological Stress, and Sex-Specific Factors. FASEB J. 2025 Sep 15;39(17):e70993. doi: 10.1096/fj.202502198R.

  PMID: 40892712 DERIVED

Study Officials

• Rebecca BILLETTE DE VILLEMEUR, MD

  MEDES - IMPS

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 9, 2022
• Study Start: August 23, 2022
• Primary Completion: November 24, 2022
• Study Completion: November 24, 2022
• Last Updated: April 24, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)