CO2 Supplement for Treatment of Acute Mountain Sickness

NCT06393998 | Completed

• 1 other identifier: 2020 037
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute mountain sickness; CO2 inhalation; central sleep apnea

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  72 hours

Secondary Outcomes (4)

• Central sleep apnea index based on PSG

  72 hours

• Sleep quality based on PSG

  72 hours

• Workload in the incremental ergometer test

  72 hours

• Exercise duration in the incremental ergometer test

  72 hours

Study Arms (2)

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.

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.

Device: Sleep and doing exercise test under inhalation of air

Interventions

Breathing with CO2 during daytime and night at high altitude DEVICE

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.

Also known as: Sleep and doing exercise test under inhalation of CO2

Breathing with CO2 during daytime and night at high altitude

Sleep and doing exercise test under inhalation of air DEVICE

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

Breathing with air during daytime and night at high altitude

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Key Laboratory of Respiratory Disease: lead

Study Sites (1)

Guangzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Altitude Sickness; Respiratory Aspiration; Mucopolysaccharidosis IV; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yuanming Luo, PhD

  Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: May 1, 2024
• Study Start: June 7, 2024
• Primary Completion: July 15, 2024
• Study Completion: September 2, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be shared after the paper of this study publishing.
• Access Criteria: After the paper of this study publishing

Locations

CN (1)