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CO2 Supplement for Treatment of Acute Mountain Sickness

NCT06393998 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-18

No results posted yet for this study

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. 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.

Conditions

  • Acute Mountain Sickness
  • High Altitude
  • Inhalation; Gas

Interventions

DEVICE

Breathing with CO2 during daytime and night at high altitude

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.

DEVICE

Sleep and doing exercise test under inhalation of air

Subjects wear the mask connecting to air supplied by the novel device during daytime and sleep dependent on the randomization once arriving high altitude.

Sponsors & Collaborators

  • State Key Laboratory of Respiratory Disease

    lead OTHER

Principal Investigators

  • Yuanming Luo, PhD · Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-07
Primary Completion
2024-07-15
Completion
2024-09-02

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06393998 on ClinicalTrials.gov