Acute Mountain SicknessNCT06393998
CO2 Supplement for Treatment of Acute Mountain Sickness
A study testing Breathing with CO2 during daytime and night at high altitude and Sleep and doing exercise test under inhalation of air in people with Acute Mountain Sickness and High Altitude, run by State Key Laboratory of Respiratory Disease at 1 site in China.
Trial summary
It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness, High Altitude, Inhalation; Gas
- What is being tested?
- Breathing with CO2 during daytime and night at high altitude and Sleep and doing exercise test under inhalation of air
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to 2 Sep 2024
- 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
- BMI less than 25kg/m2
- normal lung function.
- Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
Who cannot join
- insomnia,
- moderate or severe OSA based on PSG at sea level (AHI> 15 events/hr).
- visited to an altitude >2500 m in the preceding year.
- Currently using medicines for diabetes, hypertension et al.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CO2 Supplement for Prophylaxis and Treatment of Acute Mountain Sickness Using Novel Device
It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. It has also been well documented that exercise capacity was impaired at high altitude. Oxygen inhalation is the most effective treatment method, but it is impractical for outdoor activities because of the large volume required. There are some drugs such as acetazolamide, and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use. It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA. There is no available device which can accurately supply constant CO2 and is functionally free of dead space. We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS.
Read the detailed description
Objective: To determine whether, after rapid ascent to high altitude the device could reduce the incidence and severity of AMS as defined by AMS scores, improve sleep quality and reduce central sleep apnea events.
Methods: A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude (>1000m) a year before the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep. Blood gases will be measured 30 minutes after inhalation of air or CO2. SaO2, heart rate, and respiratory rate will be recorded every two hours. AMS (Lake Louise Acute Mountain Sickness Score) will be recorded before and after sleep. PSG including diaphragm EMG would be recorded under CO2 or air. Exercise time, ventilation heart rate, respiratory rate, and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or ambient air.
- Conditions
- Acute Mountain Sickness, High Altitude, Inhalation; Gas
- Being tested
- Breathing with CO2 during daytime and night at high altitude, Sleep and doing exercise test under inhalation of air
- Keywords
- Acute mountain sickness, CO2 inhalation, central sleep apnea
- Medical subject headings
- Altitude Sickness, Respiratory Aspiration, Mucopolysaccharidosis IV, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing with CO2 during daytime and night at high altitudeDevice
Also called Sleep and doing exercise test under inhalation of CO2
Subjects wear the mask connecting to low dose CO2 supplied by a novel device during daytime and sleep dependent on the randomization once arriving high altitude.
Sleep and doing exercise test under inhalation of airDevice
Subjects wear the mask connecting to air supplied by the novel device during daytime and sleep dependent on the randomization once arriving high altitude.
| Study group | Role | What they receive |
|---|---|---|
| Breathing with CO2 during daytime and night at high altitude | Active comparator | Subjects will sleep and perform exercise tests under inhalation of low concentration of CO2 supplied by a novel device at high altitude. Receives: Device: Breathing with CO2 during daytime and night at high altitude |
| Breathing with air during daytime and night at high altitude | Placebo comparator | Subjects will sleep and perform exercise tests under inhalation of air at high altitude. Receives: Device: Sleep and doing exercise test under inhalation of air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of acute mountain sickness (AMS)
Incidence rate of AMS based on Louis's scores under inhalation of CO2 and ambient air. The maximum score is 12 points, and a score greater than 3 indicates the presence of AMS.
Measured: 72 hours
The severity of AMS
The severity of AMS based on Louis's scores under inhalation of CO2 and ambient air. A score of 3-5 indicates mild AMS, a score of 6-9 indicates moderate AMS and a score of 10-12 indicates severe AMS.
Measured: 72 hours
Secondary outcomes (4)
Central sleep apnea index based on PSG
Changes of central sleep apnea index under inhalation of CO2 and ambient air.
Measured: 72 hours
Sleep quality based on PSG
Changes of sleep quality under inhalation of CO2 and ambient air.
Measured: 72 hours
Workload in the incremental ergometer test
Changes of workload in the incremental ergometer test under inhalation of CO2 and ambient air.
Measured: 72 hours
Exercise duration in the incremental ergometer test
Changes of exercise duration in the incremental ergometer test under inhalation of CO2 and ambient air.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start7 Jun 2024
- Primary completion15 Jul 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies 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
- 46 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, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393998
- Sponsor's protocol ID
- 2020 037
- Status last verified
- Dec 2024
- First submitted
- 20 Apr 2024
- Last updated
- 18 Dec 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Supplement for Prophylaxis and Treatment of Acute Mountain Sickness Using Novel Device
- ClinicalTrials.gov ID
- NCT06393998
- Acronym / sponsor ID
- 2020 037
- Conditions
- Acute Mountain Sickness, High Altitude, Inhalation; Gas
- Keywords
- Acute mountain sickness, CO2 inhalation, central sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- State Key Laboratory of Respiratory DiseaseUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 1 May 2024 (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.
It was reported that up to 76% people who rapidly ascend to the altitude higher than 4500 m without sufficient acclimatization will have AMS which often develops 6-8 hours after reaching at high altitude. AMS could be improved if there is no continuous ascent although central sleep apnea may persist much longer. It has also been well documented that exercise capacity was impaired at high altitude. Oxygen inhalation is the most effective treatment method, but it is impractical for outdoor activities because of the large volume required. There are some drugs such as acetazolamide, and ibuprofen for relieving AMS but side effects and inconsistent treatment effect made them to be difficulty for routine use. It is noted that adding CO2 might be useful for improvement of hypoxia and exercise ability and eliminating CSA. There is no available device which can accurately supply constant CO2 and is functionally free of dead space. We innovated a portable device with a special mask for supplement of CO2 for prophylaxis and treatment of AMS.
Detailed description
Objective: To determine whether, after rapid ascent to high altitude the device could reduce the incidence and severity of AMS as defined by AMS scores, improve sleep quality and reduce central sleep apnea events.
Methods: A randomized placebo-controlled study will be performed in 36 healthy adults with no history of travelling to high altitude (>1000m) a year before the study. Subjects will be randomly and blindly given either CO2 mixed with air or air alone during daytime and sleep. Blood gases will be measured 30 minutes after inhalation of air or CO2. SaO2, heart rate, and respiratory rate will be recorded every two hours. AMS (Lake Louise Acute Mountain Sickness Score) will be recorded before and after sleep. PSG including diaphragm EMG would be recorded under CO2 or air. Exercise time, ventilation heart rate, respiratory rate, and SaO2 will be recorded and maximal load and peak ventilation will be measured during incremental cycle exercise with inhalation of CO2 or 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 |
|---|---|---|
| Breathing with CO2 during daytime and night at high altitude | Active comparator | Device: Breathing with CO2 during daytime and night at high altitudeSubjects will sleep and perform exercise tests under inhalation of low concentration of CO2 supplied by a novel device at high altitude. |
| Breathing with air during daytime and night at high altitude | Placebo comparator | Device: Sleep and doing exercise test under inhalation of airSubjects will sleep and perform exercise tests under inhalation of 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 (3 listed)
- BMI less than 25kg/m2
- normal lung function.
- Healthy lowlanders (<500m) who have no history to travel to high altitude (>1000m) a year before the study.
Key exclusion criteria (4 listed)
- insomnia,
- moderate or severe OSA based on PSG at sea level (AHI> 15 events/hr).
- visited to an altitude >2500 m in the preceding year.
- Currently using medicines for diabetes, hypertension et al.
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 |
|---|---|---|
| Breathing with CO2 during daytime and night at high altitudeAlso: Sleep and doing exercise test under inhalation of CO2Subjects wear the mask connecting to low dose CO2 supplied by a novel device during daytime and sleep dependent on the randomization once arriving high altitude. | Device | Breathing with CO2 during daytime and night at high altitude |
| Sleep and doing exercise test under inhalation of airSubjects wear the mask connecting to air supplied by the novel device during daytime and sleep dependent on the randomization once arriving high altitude. | Device | Breathing with air during daytime and night at high altitude |
Primary outcome
Incidence rate of acute mountain sickness (AMS)
Time frame: 72 hours
Incidence rate of AMS based on Louis's scores under inhalation of CO2 and ambient air. The maximum score is 12 points, and a score greater than 3 indicates the presence of AMS.
The severity of AMS
Time frame: 72 hours
The severity of AMS based on Louis's scores under inhalation of CO2 and ambient air. A score of 3-5 indicates mild AMS, a score of 6-9 indicates moderate AMS and a score of 10-12 indicates severe AMS.
4 secondary outcomes
Central sleep apnea index based on PSG
Time frame: 72 hours
Sleep quality based on PSG
Time frame: 72 hours
Workload in the incremental ergometer test
Time frame: 72 hours
Exercise duration in the incremental ergometer test
Time frame: 72 hours
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 Dec 2024.
- Individual participant dataSharing planned: Yes. The data will be shared after the paper of this study publishing.
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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.
Yuanming Luo, PhD principal investigator
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 Breathing with CO2 during daytime and night at high altitude and Sleep and doing exercise test under inhalation of air in people with Acute Mountain Sickness and High Altitude, 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 3 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: finished, as of the sponsor's last update on 18 Dec 2024. 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?
Incidence rate of acute mountain sickness (AMS) (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 18 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.