High AltitudeNCT05798416
Effect of Inhalation of Low Dose CO2 on Exercise Performance at High Altitude
A study testing Exercise under inhalation CO2 and Exercise under inhalation ambient air in people with High Altitude and Inhalation; Gas, run by State Key Laboratory of Respiratory Disease at 1 site in China.
Trial summary
High altitude (>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude, Inhalation; Gas, Acute Mountain Sickness
- What is being tested?
- Exercise under inhalation CO2 and Exercise under inhalation ambient air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 29 Apr 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
- Healthy high altitude (4500m) residents who have not left the inhabited area over the last twelve months before the study.
Who cannot join
- 1. Subjects with cardiovascular diseases, respiratory diseases and neuromuscular diseases which could affect exercise.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: Effect of Supplement of CO2 Using Novel Portable Device on Exercise Performance at High Altitude
High altitude (>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. However, no device is currently available that can supply a constant low dose of CO2 during free movement at high altitude. We have recently invented a portable device which is small and light enough for supplement of low dose CO2 during field exercise at high altitude.
Read the detailed description
Objective: To determine whether the supplement of low-dose CO2 by the novel device could improve exercise performance at high altitude.
Methods: The lowlanders (<500m) who have no history of travelling to high altitude (>1000m) a year before the study will be recruited. And the subjects who are high-altitude residents and have not left high altitude over the last twelve months will also be recruited for the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during endurance shuttle walking test (ESWT). Blood gases will be measured before and after inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2), and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared during inhalation of CO2 and during inhalation of ambient air.
- Conditions
- High Altitude, Inhalation; Gas, Acute Mountain Sickness
- Being tested
- Exercise under inhalation CO2, Exercise under inhalation ambient air
- Keywords
- High altitude, Exercise performance, CO2 inhalation
- Medical subject headings
- Altitude Sickness, Respiratory Aspiration, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise under inhalation CO2Drug
Also called inhalation of low dose CO2
Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2
Exercise under inhalation ambient airOther
Participants perform shuttle walk test at high altitude while inhaling ambient air
| Study group | Role | What they receive |
|---|---|---|
| Exercise under inhalation of CO2 | Active comparator | Subjects will perform shuttle walk test under inhalation of low concentration of CO2 supplied by a novel device at high altitude. Receives: Drug: Exercise under inhalation CO2 |
| Exercise under inhalation of ambient air | Placebo comparator | Subjects will perform shuttle walk test under inhalation of ambient air at high altitude. Receives: Other: Exercise under inhalation ambient air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the distance in walking test
Changes in walking distance under inhalation of CO2 and ambient air
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start15 Feb 2023
- Primary completion15 Apr 2023
- Study completion29 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High AltitudeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Key Laboratory of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Ming Luo, State Key Laboratory of Respiratory Disease
- Investigators
- Yuanming Luo, PhD, Principal investigator, The Affiliated Hospital og Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798416
- Sponsor's protocol ID
- 2020 No.37
- Status last verified
- May 2023
- First submitted
- 10 Mar 2023
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared after the paper of this study publishing.
Publications
Liang S, Catcheside P, Wellman A, Wu L, Wang L, Steier J, He B, Schwartz AR, Eckert DJ, Luo Y. Low-Dose CO2 Inhalation to Improve Oxygenation and Exercise Capacity at High Altitude: A Double-Blind Pilot Study. Respirology. 2026 Jul 10. doi: 10.1002/resp.70278. Online ahead of print.
PubMed 42429551
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplement of CO2 Using Novel Portable Device on Exercise Performance at High Altitude
- ClinicalTrials.gov ID
- NCT05798416
- Acronym / sponsor ID
- 2020 No.37
- Conditions
- High Altitude, Inhalation; Gas, Acute Mountain Sickness
- Keywords
- High altitude, Exercise performance, CO2 inhalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- State Key Laboratory of Respiratory DiseaseUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 29 Apr 2023 (actual)
- First posted
- 4 Apr 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.
High altitude (>2400 m) is associated with decreased atmosphere pressure leading to hypoxia which in turn impairs exercise capacity and causes acute mountain sickness (AMS). It is noted that adding CO2 might be beneficial to improve hypoxia and exercise performance at high altitude. However, no device is currently available that can supply a constant low dose of CO2 during free movement at high altitude. We have recently invented a portable device which is small and light enough for supplement of low dose CO2 during field exercise at high altitude.
Detailed description
Objective: To determine whether the supplement of low-dose CO2 by the novel device could improve exercise performance at high altitude.
Methods: The lowlanders (<500m) who have no history of travelling to high altitude (>1000m) a year before the study will be recruited. And the subjects who are high-altitude residents and have not left high altitude over the last twelve months will also be recruited for the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during endurance shuttle walking test (ESWT). Blood gases will be measured before and after inhalation of CO2. ESWT time, ventilation per minute (VE), blood oxygen saturation (SPO2), and end-tidal CO2 concentration (ETCO2) will be measured during exercise and will be compared during inhalation of CO2 and during inhalation of ambient air.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise under inhalation of CO2 | Active comparator | Drug: Exercise under inhalation CO2Subjects will perform shuttle walk test under inhalation of low concentration of CO2 supplied by a novel device at high altitude. |
| Exercise under inhalation of ambient air | Placebo comparator | Other: Exercise under inhalation ambient airSubjects will perform shuttle walk test under inhalation of ambient air at high altitude. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
- Healthy high altitude (4500m) residents who have not left the inhabited area over the last twelve months before the study.
Key exclusion criteria (1 listed)
- 1. Subjects with cardiovascular diseases, respiratory diseases and neuromuscular diseases which could affect exercise.
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 |
|---|---|---|
| Exercise under inhalation CO2Also: inhalation of low dose CO2Participants perform shuttle walk test at high altitude while using the novel portable device for inhalation of CO2 | Drug | Exercise under inhalation of CO2 |
| Exercise under inhalation ambient airParticipants perform shuttle walk test at high altitude while inhaling ambient air | Other | Exercise under inhalation of ambient air |
Primary outcome
Change of the distance in walking test
Time frame: 48 hours
Changes in walking distance under inhalation of CO2 and ambient air
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 42429551Liang S, Catcheside P, Wellman A, Wu L, Wang L, Steier J, He B, Schwartz AR, Eckert DJ, Luo Y. Low-Dose CO2 Inhalation to Improve Oxygenation and Exercise Capacity at High Altitude: A Double-Blind Pilot Study. Respirology. 2026 Jul 10. doi: 10.1002/resp.70278. Online ahead of print.
- Individual participant dataSharing planned: Yes. The data will be shared after the paper of this study publishing.
Related trials for High Altitude
Not yet recruiting
High-flow Nasal Cannula Oxygen Therapy Versus Conventional Oxygen Therapy in Children High-altitude Pulmonary Edema
High-altitude Pulmonary Edema
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Optimization of Two-Indicator Screening Protocol for Neonatal Congenital Heart Disease at High Altitude
Neonatal Congenital Heart Disease
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H
High Altitude, Healthy Adult
Not yet recruiting
Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH
Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease
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.
Yuanming Luo, PhD principal investigator
The Affiliated Hospital og Guangzhou Medical 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 Exercise under inhalation CO2 and Exercise under inhalation ambient air in people with High Altitude and Inhalation; Gas, run by State Key Laboratory of Respiratory Disease at 1 site in China.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 18 May 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the distance in walking test (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798416, which also lists 1 linked publication.
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 18 May 2023.