Evaluation of the Response to Hypoxia at Rest and During Exercise in a Healthy Subject After a Cryostimulation Exposure (CRYOX)

January 25, 2024 updated by: Poitiers University Hospital

Many information is available regarding human adaptations to cold or hypoxia. Adaptations to these environments and physical exercise constitute responses to physiological stress aimed at amplifying the organism's reactions and improving its performance. However, studies conducted so far to understand these adaptations and their underlying mechanisms have been organized in a dissociated manner, with each study focusing on only one of these specific situations (cold, hypoxia, or exercise). Understanding cross-adaptations is crucial, as human beings are often simultaneously exposed to several of these stimuli, and understanding this cross-exposure can be considered a prerequisite for pre-acclimatization strategies to these different environments.

Cross-adaptations has been defined as follows: "It simply involves considering that long-term exposure (either continuous or intermittent) to a given unfavorable environment not only increases tolerance to that particular environment but also leads to gains or losses of tolerance to other unfavorable factors that the adapted organism had never encountered before." When specifically examining cross-adaptations to cold and hypoxia, only one study focusing on the human model is available. The lack of perspectives and positions regarding the results calls for further investigations.

The main objective of this study is to assess the effect of repeated exposures to cryostimulation on the variation of the respiratory exchange ratio in hypoxia during exercise.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

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 Contact Backup

Study Locations

  • France
      • Poitiers, France, 86000
        • Laboratoire MOVE UR 20296 - Poitiers University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benoit DUGUE, PhD
        • Principal Investigator:
          • Aurélien PICHON, PhD
        • Sub-Investigator:
          • Corentin FAUCHER, MSc
      • Poitiers, France, 86021
        • Clinical Investigation Centre INSERM CIC1402 - Poitiers University - CHU POITIERS
        • Contact:
        • Principal Investigator:
          • Pierre Jean SAULNIER, MD PhD
        • Sub-Investigator:
          • Christophe RAULT, MD

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having a high level of physical activity according to the criteria of the World Health Organization, assessed using the Global Physical Activity Questionnaire (GPAQ);
  • No exposure to cryostimulation or hypoxia (FiO2 13.5%, equivalent to an altitude of 3500 m) in the last 90 days;
  • No planned sports competition during the 4 weeks of the protocol;
  • Maintaining a stable physical activity level (regular training, without interruption or specific competition, including sports training programs) anticipated for 4 weeks;
  • No history of respiratory conditions (asthma, respiratory allergies, exercise-induced asthma, exertional dyspnea);
  • Absence of any chronic medical condition;
  • No ongoing medication treatments;
  • Covered by a French Social Security;
  • Informed consent, signed by the subject after clear and fair information about the study.

Exclusion Criteria:

  • Subject under treatment;
  • Simultaneous participation in another clinical research study;
  • Individuals with enhanced protection, namely minors, individuals deprived of liberty by judicial or administrative decision, persons staying in a healthcare or social facility, adults under legal protection, and finally, patients in emergency situations;
  • Subject presenting a contraindication to hypoxia and/or cryostimulation.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Participants will not undergo cryostimulation exposure but will only receive 2 1-hour hypoxia sessions at FiO2 13.5% for 1 hour, at 2-week interval
Experimental: Cryostimulation Group
Participants will be exposed to cryostimulation (-50°C, forced ventilation for 3 minutes) during 20 sessions over 2 weeks and will undergo 2 hypoxia sessions at FiO2 13.5% for 1 hour, at 2-week interval
Other: Cryostimulation
Cryostimulation (-50°C, forced ventilation for 3 minutes) during 20 sessions over 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of the respiratory quotient during exercise
Time Frame: Comparing the average values obtained during exercise in hypoxia at baseline and after 15 days.
respiratory exchange ratio will be measured continuously using a portable metabolic station to analyze gas exchanges
Comparing the average values obtained during exercise in hypoxia at baseline and after 15 days.

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

Collaborators

Poitiers University - Laboratoire MOVE UR 20296, France

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)

January 25, 2024

Primary Completion (Estimated)

February 25, 2025

Study Completion (Estimated)

May 25, 2025

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYOX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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