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Starting soon Not applicable

VENTILATION DURING SPACEFLIGHT (PHASE 2)

NCT07435389 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-10-06
Last updated
2026-09-25

Condition(s) studied

Non-invasive Ventilation

Investigational drug(s) / intervention(s)

non-invasive oxygenation strategies

non-invasive oxygenation strategies: A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask (Intersurgical): specific settings (AI 10 cmH2O, PEEP 5 cmH2O, FiO2 21%, etc.). B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical): specific settings (AI 10 cmH2O, PEEP 5 cmH2O, FiO2 21%, etc.). C. Standard oxygen therapy without EcoLite gas mask (Intersurgical)

Study summary

Space flights expose astronauts to medical risks, particularly respiratory risks, which are exacerbated in microgravity. Devices such as standard oxygen therapy and non-invasive ventilation (NIV) are used, but their performance in microgravity remains poorly studied. Parabolic flights allow these technologies to be evaluated in conditions similar to those encountered during space missions. In an initial study conducted in microgravity during a parabolic flight campaign, the T1 ventilator proved superior to the other devices tested on the test bench. However, its performance in healthy volunteers has not yet been evaluated. The central hypothesis of this exploratory study on healthy volunteers is that non-invasive ventilation, particularly with the CaStar UP helmet (Intersurgical), could offer superior performance to the standard oxygen mask in microgravity, thanks to better leak reduction (data from preclinical work on a test bench).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy volunteers (male or female) * Aged 18 to 65 * Affiliated with a Social Security scheme and, for non-French residents, holders of a European Health Insurance Card (EHIC) or a Global Health Insurance Card (GHIC) * Agreeing to participate in the study * Agreeing to participate in the study * Having given their informed consent in writing * Who have undergone a medical examination similar to a standard aeronautical medical examination for private pilot fitness Exclusion Criteria: * Individuals who have participated in a previous biomedical research protocol * whose exclusion period has not ended. * Individuals in a subordinate relationship with the principal investigator or scientific director. * Pregnant or breastfeeding women (urine pregnancy test for women of childbearing age). * Protected adults (under guardianship, curatorship, or judicial protection) * Flu-like symptoms, digestive symptoms (nausea, vomiting), fever. * Altered mental state (flight-related anxiety, phobic state). * Failure to attend the Novespace safety briefing.

Primary outcome measure(s)

  • Expiratory tidal volume — 24 hours

Trial sites (1)

FacilityCityRegionStatus
CHR Metz-Thionville Metz France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07435389 on ClinicalTrials.gov ↗ ← All trials in France