HypoxiaNCT02523716
Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
A study testing Hypoxia and Normoxia in people with Hypoxia, run by University of Limerick.
Trial summary
To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Hypoxia and Normoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 30 Dec 2015
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female individuals aged 50-70 years with sedentary lifestyles.
Who cannot join
- Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
- Non-availability and/or suitability to complete the required residential period within the altitude centre.
About this study
To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.
Read the detailed description
Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).
Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.
The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.
- Conditions
- Hypoxia
- Being tested
- Hypoxia, Normoxia
- Keywords
- Hypoxic conditioning, Cardio pulmonary exercise testing
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaOther
Participants live within an altitude residence facility. Hypoxic acclimatisation will be achieved by venting the rooms with air containing a reduced oxygen content. The degree of hypoxia is ramped over a 2-day period as participants experience 14 hours of overnight hypoxic exposure (simulating altitude of : 1830m on Day 1; 2130m on Day 2). The final 5 days will be spent entirely in the altitude residence facility at a consistent hypoxia level (simulating approximately 2440m).
NormoxiaOther
Participants will live in the altitude residence facility. As a sham-control, normal sea level air will be circulated throughout the house.
| Study group | Role | What they receive |
|---|---|---|
| Hypoxia | Experimental | Mild hypoxia of 15% oxygen, equivalent altitude of 2440m over a period of 7 days Receives: Other: Hypoxia |
| Normoxia | Sham comparator | Exposure to normal, sea-level air Receives: Other: Normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cardio pulmonary functional variables
Assess cardio pulmonary functional variables using cardio pulmonary exercise testing (CPET) prior and following participants completing each arm of the study
Measured: Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startMay 2015
- Primary completion30 Sep 2015
- Study completion30 Dec 2015
Why it stopped: Failure to maintain access to Altitude Facility
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Thomas Smith (Chief Investigator), MBBS, DPhil, FRCA, FAsMA, Principal investigator, University of OxfordPhillip Jakeman, BSc, MSc, PhD, Principal investigator, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523716
- Sponsor's protocol ID
- 2014_02_33
- Status last verified
- Apr 2021
- First submitted
- 2 Jun 2015
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Simulated Altitude Exposure on Cardiopulmonary Functional Capacity
- ClinicalTrials.gov ID
- NCT02523716
- Acronym / sponsor ID
- 2014_02_33
- Conditions
- Hypoxia
- Keywords
- Hypoxic conditioning, Cardio pulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to maintain access to Altitude Facility
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- May 2015
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 14 Aug 2015 (estimated)
- 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.
To determine if exposure of older volunteers, age 50-70y, who are healthy, but not physically active, to 7 days of mild hypoxia (15% oxygen, equivalent 2440m) will improve cardiopulmonary functional capacity.
Detailed description
Background There is an urgent need to reduce morbidity and mortality following major surgery. Bodily demands for oxygen increase after major surgery, and postoperative outcomes can be predicted by quantifying the body's ability to meet increased mitochondrial demand for oxygen using cardiopulmonary exercise testing (CPET).
Design This is a preliminary, physiological study to establish the baseline relationship between mild hypoxia exposure and cardiopulmonary function. This study will begin to examine the feasibility and potential for achieving risk modification through low-oxygen (hypoxic) conditioning, in which a safe and convenient "dose" of mild hypoxia is used to improve CPET derived variables that predict mortality following surgery.
The study will use a randomised, double blind, sham-controlled, crossover design. After a baseline CPET test, participants will be exposed to 7 days of either mildly hypoxic or normoxic air. A follow up CPET test will then be used to determine if cardiopulmonary functional capacity increased after exposure. After a two week washout period, participants will return for a second 7-day session where the alternate exposure will be given. A final follow-up CPET test will then be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypoxia | Experimental | Other: HypoxiaMild hypoxia of 15% oxygen, equivalent altitude of 2440m over a period of 7 days |
| Normoxia | Sham comparator | Other: NormoxiaExposure to normal, sea-level air |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male and female individuals aged 50-70 years with sedentary lifestyles.
Key exclusion criteria (2 listed)
- Known intolerance to altitude identified by the participant's clinical examination, history and pre-altitude screening completed by the research clinician.
- Non-availability and/or suitability to complete the required residential period within the altitude centre.
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 |
|---|---|---|
| HypoxiaParticipants live within an altitude residence facility. Hypoxic acclimatisation will be achieved by venting the rooms with air containing a reduced oxygen content. The degree of hypoxia is ramped over a 2-day period as participants experience 14 hours of overnight hypoxic exposure (simulating altitude of : 1830m on Day 1; 2130m on Day 2). The final 5 days will be spent entirely in the altitude residence facility at a consistent hypoxia level (simulating approximately 2440m). | Other | Hypoxia |
| NormoxiaParticipants will live in the altitude residence facility. As a sham-control, normal sea level air will be circulated throughout the house. | Other | Normoxia |
Primary outcome
Change in Cardio pulmonary functional variables
Time frame: Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.
Assess cardio pulmonary functional variables using cardio pulmonary exercise testing (CPET) prior and following participants completing each arm of the study
Results and safety
The study was stopped early (reason given: Failure to maintain access to Altitude Facility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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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.
Thomas Smith (Chief Investigator), MBBS, DPhil, FRCA, FAsMA principal investigator
University of Oxford
Phillip Jakeman, BSc, MSc, PhD principal investigator
University of Limerick
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia and Normoxia in people with Hypoxia, run by University of Limerick.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Failure to maintain access to Altitude Facility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cardio pulmonary functional variables (time frame: Change in Cardio pulmonary functional variables between day 0 and day 7 in each arm of the study.). 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 6 Dec 2023.