CO2 Supplement for Treatment of Acute Mountain Sickness

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06393998
Study type	Interventional
Source	State Key Laboratory of Respiratory Disease
Contact	Yuanming Luo, PhD
Phone	+8613570033081
Email	y.m.luo@vip.163.com
Status	Not yet recruiting
Phase	N/A
Start date	May 15, 2024
Completion date	August 15, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.