HypoxiaCRYOXNCT06174480
Evaluation of the Response to Hypoxia at Rest and During Exercise in a Healthy Subject After a Cryostimulation Exposure
A study testing Cryostimulation in people with Hypoxia and Cryostimulation, run by Poitiers University Hospital at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Cryostimulation, Metabolism
- What is being tested?
- Cryostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Jan 2024to 25 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- No ongoing medication treatments;
- Covered by a French Social Security;
- Informed consent, signed by the subject after clear and fair information about the study.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Laboratoire MOVE UR 20296 - Poitiers University
Poitiers, 86000
Benoit DUGUE, PhD, benoit.dugue@univ-poitiers.fr
Aurélien PICHON, PhD, aurelien.pichon@univ-poitiers.fr
Clinical Investigation Centre INSERM CIC1402 - Poitiers University - CHU POITIERS
Poitiers, 86021
Elodie MIGAULT, elodie.migault@chu-poitiers.fr
Pierre Jean SAULNIER, MD PhD
About this study
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.
- Conditions
- Hypoxia, Cryostimulation, Metabolism, Autonomic Nervous System, Exercise, Adaptation
- Being tested
- Cryostimulation
- Medical subject headings
- Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryostimulationOther
Cryostimulation (-50°C, forced ventilation for 3 minutes) during 20 sessions over 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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 |
| Cryostimulation Group | Experimental | 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 Receives: Other: Cryostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of the respiratory quotient during exercise
respiratory exchange ratio will be measured continuously using a portable metabolic station to analyze gas exchanges
Measured: Comparing the average values obtained during exercise in hypoxia at baseline and after 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start25 Jan 2024 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Poitiers University - Laboratoire MOVE UR 20296, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174480
- Sponsor's protocol ID
- CRYOX
- Acronym
- CRYOX
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Response to Hypoxia at Rest and During Exercise in a Healthy Subject After a Cryostimulation Exposure
- ClinicalTrials.gov ID
- NCT06174480
- Acronym / sponsor ID
- CRYOX / CRYOX
- Conditions
- Hypoxia, Cryostimulation, Metabolism, Autonomic Nervous System, Exercise, Adaptation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Poitiers University - Laboratoire MOVE UR 20296, France
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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 |
| Cryostimulation Group | Experimental | Other: CryostimulationParticipants 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryostimulationCryostimulation (-50°C, forced ventilation for 3 minutes) during 20 sessions over 2 weeks. | Other | Cryostimulation Group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryostimulation in people with Hypoxia and Cryostimulation, run by Poitiers University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Corentin FAUCHER, MSc (+33540453343, corentin.faucher@univ-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of the respiratory quotient during exercise (time frame: Comparing the average values obtained during exercise in hypoxia at baseline and after 15 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.