VENTILATION DURING SPACEFLIGHT (PHASE 2) (VESPA-2)

February 25, 2026 updated by: Centre Hospitalier Régional Metz-Thionville
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABC
A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) C. Standard oxygen therapy without EcoLite gas mask
Device: 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)
Experimental: ACB
A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask C. Standard oxygen therapy without EcoLite gas mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical)
Device: 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)
Experimental: BAC
B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask C. Standard oxygen therapy without EcoLite gas mask
Device: 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)
Experimental: BCA
B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) C. Standard oxygen therapy without EcoLite gas mask A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask
Device: 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)
Experimental: CAB
C. Standard oxygen therapy without EcoLite gas mask A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical)
Device: 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)
Experimental: CBA
C. Standard oxygen therapy without EcoLite gas mask B. Non-invasive ventilation with T1 ventilator (Hamilton) and CaStar UP helmet (Intersurgical) A. Non-invasive ventilation with T1 ventilator (Hamilton) and BiTrac mask
Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expiratory tidal volume
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional Metz-Thionville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 16, 2026

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

March 20, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-03-CHRMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-invasive Ventilation

Clinical Trials on non-invasive oxygenation strategies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe