HypoxiaHYPOXAGENCT05048680
Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
A study testing Hypoxia and/or Exercise in people with Hypoxia and Cerebral Hypoxia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Cerebral Hypoxia, Brain Diseases
- What is being tested?
- Hypoxia and/or Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2021to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 to 80 years of age;
- Being physically inactive (less than 150 min/week of moderate to intense physical activity);
- No chronic cardiovascular, respiratory, metabolic or neuromuscular disease counterindicating an exercise training or hypoxic conditioning program;
- Health coverage;
- Being able to provide written fully informed consent.
Who cannot join
- Body-mass index >30 kg/m2;
- Smoking (> cigarettes/day);
- Alcohol use (> 10g/day);
- Mental disorder or history of mental disorder;
- Beta-blockade treatment;
- Inability or refusal to provide informed consent;
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- No health coverage
- People exceeding the annual ceiling of allowances received as a result of their participation in other clinical trials;
- People deprived of freedom by judicial or administrative decision;
- People subject to legal protection, who cannot be included in clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
La Tronche, Auvergne-Rhône-Alpes, 38700
Stéphane Doutreleau, MD, PhD, +33476767773, sdoutreleau@chu-grenoble.fr
Samuel Vergès, PhD, +33476766860, sverges@chu-grenoble.fr
About this study
In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.
- Conditions
- Hypoxia, Cerebral Hypoxia, Brain Diseases, Exercise, Aging, Cognitive Decline
- Being tested
- Hypoxia and/or Exercise
- Medical subject headings
- Hypoxia, Hypoxia, Brain, Brain Diseases, Motor Activity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxia and/or ExerciseProcedure or surgery
Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia - Rest | Experimental | Sessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest. Receives: Procedure: Hypoxia and/or Exercise |
| Normoxia - Rest | Placebo comparator | Sessions of normoxia at rest; 3 sessions/week; 8 weeks. Receives: Procedure: Hypoxia and/or Exercise |
| Hypoxia - Exercise | Experimental | Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group. Receives: Procedure: Hypoxia and/or Exercise |
| Normoxia - Exercise | Active comparator | Sessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. Receives: Procedure: Hypoxia and/or Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle cerebral artery flow velocity
Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)
Measured: Before intervention; right after intervention; 2 months after intervention
Secondary outcomes (6)
Peak oxygen uptake
Peak oxygen uptake during a cardiopulmonary exercise test
Measured: Before intervention; right after intervention; 2 months after intervention
Flow-mediated dilation
Flow-mediated dilation in response to ischemia-reperfusion of the brachial artery
Measured: Before intervention; right after intervention; 2 months after intervention
Blood pressure
24h (systolic, diastolic and mean) blood pressure assessment
Measured: Before intervention; right after intervention; 2 months after intervention
Sleep
Sleep features assessed by polygraphy
Measured: Before intervention; right after intervention; 2 months after intervention
Cognitive function
Cognitive function assessed by the Montreal Cognitive Assessment questionnaire
Measured: Before intervention; right after intervention; 2 months after intervention
Health-related quality of life
Health-related quality of life assessed by the SF-36 questionnaire
Measured: Before intervention; right after intervention; 2 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start13 Oct 2021
- Primary completion17 Mar 2024
- Study completionSep 2026 (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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane Doutreleau, MD, PhD, Principal investigator, CHU Grenoble Alpes, Grenoble Alpes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048680
- Sponsor's protocol ID
- 38RC20.460
- Acronym
- HYPOXAGE
- Status last verified
- May 2026
- First submitted
- 8 Sep 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan at this point in time.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypoxic Conditioning on Cerebrovascular Health in the Elderly
- ClinicalTrials.gov ID
- NCT05048680
- Acronym / sponsor ID
- HYPOXAGE / 38RC20.460
- Conditions
- Hypoxia, Cerebral Hypoxia, Brain Diseases, Exercise, Aging, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 17 Mar 2024 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Sep 2021 (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.
In line with the ever-growing aging of Western populations, the development of preventive strategies to slow down the effects of aging on cardiovascular health represents a major challenge in order to preserve functional capacities and a sufficient quality of life in the elderly. The alteration of vascular function (at the cerebral and systemic level) with aging is an important feature in the clinical picture including a decrease in physical and cognitive capacities. Although physical activity is recognized as an essential means of combating the effects of aging, optimizing its effects by defining the most effective strategies of practice remains a key objective. Offering alternative interventions to exercise training is also necessary for people who are unwilling or unable to engage in a physical activity program. In this context, hypoxic conditioning, alone or in conjunction with rehabilitative exercise training, is a new therapeutic modality with strong preclinical validity, in particular from a cardiovascular standpoint, and used in other pathologies to improve cardiovascular function and exercise performance and quality of life. Our aim is, therefore, to investigate the effect of hypoxic conditioning (alone or in conjunction with exercise training) on cerebrovascular health in the elderly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hypoxia - Rest | Experimental | Procedure: Hypoxia and/or ExerciseSessions of intermittent hypoxia at rest; 3 sessions/week; 8 weeks. To be compared with the placebo (normoxia) group at rest. |
| Normoxia - Rest | Placebo comparator | Procedure: Hypoxia and/or ExerciseSessions of normoxia at rest; 3 sessions/week; 8 weeks. |
| Hypoxia - Exercise | Experimental | Procedure: Hypoxia and/or ExerciseSessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. To be compared with the placebo (exercise under normoxia) group. |
| Normoxia - Exercise | Active comparator | Procedure: Hypoxia and/or ExerciseSessions of exercise training under hypoxia; 3 sessions/week; 8 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 60 to 80 years of age;
- Being physically inactive (less than 150 min/week of moderate to intense physical activity);
- No chronic cardiovascular, respiratory, metabolic or neuromuscular disease counterindicating an exercise training or hypoxic conditioning program;
- Health coverage;
- Being able to provide written fully informed consent.
Key exclusion criteria (10 listed)
- Body-mass index >30 kg/m2;
- Smoking (> cigarettes/day);
- Alcohol use (> 10g/day);
- Mental disorder or history of mental disorder;
- Beta-blockade treatment;
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 |
|---|---|---|
| Hypoxia and/or ExerciseHypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise. | Procedure or surgery | Hypoxia - Exercise, Hypoxia - Rest, Normoxia - Exercise, Normoxia - Rest |
Primary outcome
Middle cerebral artery flow velocity
Time frame: Before intervention; right after intervention; 2 months after intervention
Changes in middle cerebral artery flow velocity in response to hypercapnia (5% CO2)
6 secondary outcomes
Peak oxygen uptake
Time frame: Before intervention; right after intervention; 2 months after intervention
Flow-mediated dilation
Time frame: Before intervention; right after intervention; 2 months after intervention
Blood pressure
Time frame: Before intervention; right after intervention; 2 months after intervention
Sleep
Time frame: Before intervention; right after intervention; 2 months after intervention
Cognitive function
Time frame: Before intervention; right after intervention; 2 months after intervention
Health-related quality of life
Time frame: Before intervention; right after intervention; 2 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. No plan at this point in time.
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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.
Stéphane Doutreleau, MD, PhD principal investigator
CHU Grenoble Alpes, Grenoble Alpes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia and/or Exercise in people with Hypoxia and Cerebral Hypoxia, run by University Hospital, Grenoble at 1 site 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Doutreleau, MD, PhD (+33476767773, sdoutreleau@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Middle cerebral artery flow velocity (time frame: Before intervention; right after intervention; 2 months after intervention). 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 8 May 2026.