Integrative Study of Physiological Changes Induced by a 5-Day Dry Immersion on 20 Healthy Female Volunteers (DI5-Women)

NCT05043974 | Completed

• 2 other identifiers: 20-2322021-A00705-36
• 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 objective of the study is to evaluate the physiological changes induced by 5 days of dry immersion in the female organism. The main physiological systems will be explored before, during and after the 5 days of immersion through a battery of specific tests and measurements. The results will be analyzed by scientists specializing in each field in order to better understand the dry immersion model, to compare its effects with those of the bedrest model and those of spaceflight. The clinical (adverse effects, comfort of subjects) and operational aspects are also part of the secondary objectives of the study.

Conditions

Weightlessness; Weightlessness; Adverse Effect

Keywords

Simulated Microgravity; Weightlessness; Dry immersion; Supportlessness

Outcome Measures

Primary Outcomes (42)

• Change in orthostatic tolerance

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

  At baseline and after five 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 after five days of dry immersion

• Change in plasma volume

  Plasma volume (L) will be assessed by the CO-rebreathing method.

  At baseline and after five days of dry immersion

• Change in fluid shift distribution towards the cephalic region

  The hemodynamic and morphologic consequences of the fluid shift on the cephalic blood vessels (jugular vein, carotid, femoral, intracranial veins) and on the left ventricle will be investigated by ultrasound. The hormones involved in fluid distribution will be assessed in blood and urine samples

  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 score of endothelial state will be calculated.

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

• Change in circadian rhythms of blood pressure

  Continuous 24-h recording of blood pressure will be performed by SOMNOtouch™ NIBP system 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, after four days of dry-immersion and after one day of recovery

• Change in body fluid compartments by bioelectrical impedance analysis

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

  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.

  At baseline and after five days of dry-immersion

• 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 MVC value.

  At baseline and after five days of dry-immersion

• 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 after five days of dry-immersion

• Change in contraction time

  Contraction time will be assessed during a tensiomyographic test in vastus lateralis, Gastrocnemius medialis and Biceps femoris of dominant leg / arm

  At baseline and after five days of dry-immersion

• Change in bone metabolism

  Bone metabolism in response to immobilization by dry immersion will be assessed by measuring bone biomarkers in blood samples.

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

• Changes in cartilage metabolism

  Cartilage metabolism in response to immobilization by dry immersion will be assessed by measuring cartilage biomarkers in blood and urine samples.

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

• Change in Resting Metabolic Rate (RMR)

  RMR will be measured by indirect calorimetry technique

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

• Change in Body Composition measured by DEXA

  DEXA is a standard clinical technique to assess body composition

  At baseline and at the end of the 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 after 3 days of dry-immersion (to be comparable to a previous study on men)

• 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

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

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

  Transcranial Doppler measurements

  Before and after the 5 days of dry immersion

• Change in mood

  Change in mood is assessed using the Profile of Mood States (POMS) questionnaire. (POMS).

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

• Change in psychological affects

  PANAS Questionnaire will be used to assess the intensity of positive and negative affective states

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

• Change in psychological state: sleep quality

  Pittsburgh Sleep Dairy will be used to assess sleep perceived quality

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

• Change in psychological state: mental health

  GHQ-28 Questionnaire will be used to assess psychological well-being and capture distress

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

• Change in psychological state: coping strategies

  Brief Cope Questionnaire, designed to measure effective and ineffective ways to cope with a stressful life event, will be used to assess coping strategies

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

• Change in visual field

  Visual field measured by standard automated perimetry

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

• 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 after five days of dry-immersion

• Change in motion sickness susceptibility

  Motion Sickness Questionnaire

  At baseline and after five days of dry-immersion

• Change in coagulation cascade

  Coagulation cascade in response to immobilization by dry immersion will be assessed by measuring coagulation parameters in blood.

  At baseline, during and after 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: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female 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 180 cm,
• Regular menstrual cycles and cycles lasting between 20 and 35 days,
• Without oestroprogestative contraception (i.e., oral progestative contraception, IUDs, implants or absence of contraception are allowed),
• 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, ENT (especially orthostatic hypotension and vestibular disorders), orthopaedic or musculoskeletal disorders,
• Fitness level assessment:
• if age \< 35 years: 35 ml/min./kg \< VO2max \< 55 ml/min./kg,
• if age \> 35 years: 30 ml/min./kg \< VO2max \< 55 ml/min./kg,
• Non active smokers,
• No alcohol, or drug addiction, and no medical treatment (with the exception of the aforementioned accepted means of contraception),
• 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,
• Asymptomatic postural hypotension defined by a decrease in 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,
• Abnormal result for lower limbs echo-doppler,
• History of genetic muscle and bone diseases of any kind,

Sponsors & Collaborators

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

Study Sites (1)

Medes-Imps

Toulouse, 31400, France

Location

Related Publications (6)

• 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

• Robin A, Van Ombergen A, Laurens C, Bergouignan A, Vico L, Linossier MT, Pavy-Le Traon A, Kermorgant M, Chopard A, Py G, Green DA, Tipton M, Chouker A, Denise P, Normand H, Blanc S, Simon C, Rosnet E, Larcher F, Fernandez P, de Glisezinski I, Larrouy D, Harant-Farrugia I, Antunes I, Gauquelin-Koch G, Bareille MP, Billette De Villemeur R, Custaud MA, Navasiolava N. Comprehensive assessment of physiological responses in women during the ESA dry immersion VIVALDI microgravity simulation. Nat Commun. 2023 Oct 9;14(1):6311. doi: 10.1038/s41467-023-41990-4.

  PMID: 37813884 DERIVED

Study Officials

• Arnaud BECK, 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 30, 2021
• First Posted: September 14, 2021
• Study Start: August 24, 2021
• Primary Completion: December 8, 2021
• Study Completion: December 10, 2021
• Last Updated: July 21, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)