NCT05043974: VivalDI

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

Completed NA Last updated 21 July 2022

What this trial tests

NA trial testing Dry immersion in Weightlessness in 20 participants. Completed in 10 December 2021.

Timeline

24 August 2021

Primary endpoint
8 December 2021

10 December 2021

Quick facts

Lead sponsor	Centre National d'Etudes Spatiales
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	24 August 2021
Primary completion	8 December 2021
Estimated completion	10 December 2021
Sites	1 location across France

Drugs / interventions tested

• Dry immersion

Conditions studied

• Weightlessness — all drugs for Weightlessness →
• Weightlessness; Adverse Effect — all drugs for Weightlessness; Adverse Effect →

Sponsor

Centre National d'Etudes Spatiales — full company profile →

Who can join

Adults 20 to 40, female only, with Weightlessness or Weightlessness; Adverse Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microgravity-Related Changes in Bone Density and Treatment Options: A Systematic Review.
   Baran R, Wehland M, Schulz H, Heer M, et al · · 2022 · cited 27× · PMID 35955775 · DOI 10.3390/ijms23158650
2. Comprehensive assessment of physiological responses in women during the ESA dry immersion VIVALDI microgravity simulation.
   Robin A, Van Ombergen A, Laurens C, Bergouignan A, et al · · 2023 · cited 18× · PMID 37813884 · DOI 10.1038/s41467-023-41990-4
3. Dry immersion rapidly disturbs iron metabolism in men and women: results from the VIVALDI studies.
   Horeau M, Navasiolava N, Van Ombergen A, Custaud MA, et al · · 2024 · cited 4× · PMID 38879550 · DOI 10.1038/s41526-024-00399-z
4. Neuro-ophthalmological changes in healthy females exposed to a 5-day dry immersion: a pilot study.
   Kermorgant M, Chedmail T, Varenne F, Bareille MP, et al · · 2024 · cited 3× · PMID 38212301 · DOI 10.1038/s41526-024-00344-0
5. Sex-specific cardiometabolic responses during microgravity simulation in European Space Agency VIVALDI dry immersion.
   Robin A, Navasiolava N, Bergouignan A, Laurens C, et al · · 2026 · cited 1× · PMID 41912767 · DOI 10.1038/s43856-026-01540-7
6. ESA VIVALDI Dry Immersion Microgravity Simulations Induce Increases in Immune Biomarkers Associated With Physical and Psychological Stress, and Sex-Specific Factors.
   Jacob P, Robin A, Navasiolava N, Custaud MA, et al · · 2025 · cited 1× · PMID 40892712 · DOI 10.1096/fj.202502198r
7. Fluid shifts are main drivers for microgravity simulation-induced immune-physiological changes: findings from the VIVALDI studies.
   Moser D, Bareille MP, Ombergen AV, Hoerl M, et al · · 2026 · PMID 41698943 · DOI 10.1038/s41526-025-00555-z