The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Capital Medical University

Status: Enrolling

Conditions: Acute Mountain Sickness

Treatments: Other: Intermittent Hypoxia; Other: Sham Intermittent Hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT05733338

IH-AHI

Details and patient eligibility

About

This study intends to further reveal the effectiveness of intermittent hypoxia in preventing acute hypoxic injury.

Full description

Acute exposure to hypoxia can induce acute hypoxic injury (AHI), according to the severity of the injury, it can be divided into acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE). AMS is the most common type, it mostly occurs within 6-12 hours after rapidly entering the altitude above 2500m, sometimes within 1h, and can be manifested as headache, nausea, diarrhea, sleep disorders, etc. The incidence of AMS at the altitude of 2500-3000m is 10-20%, which reaches 50-85% at 4500-5000m above sea level.

Intermittent hypoxia (IH) refers to periodic hypoxic-normoxic training performed with brief exposure to hypoxia. Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and alleviate acute hypoxia injury by reducing the inflammatory response caused by hypoxia. Therefore, this study aims to conduct a randomized controlled trial to further reveal the effectiveness of IH and explore its potential mechanisms.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Informed written consent from the volunteers.
• Healthy volunteers between ages of 18 and 45 years, body mass index (BMI) of 19.0 and 24.9 kg/m2.
• Long-term residence at flatland (altitude of <100 m), not having been to an altitude ≥1500 m in 30 days.
• Resting peripheral oxygen saturation of more than 90%, cerebral oxygen saturation between 58%-82%, heart rate between 60 bpm and 100 bpm, and blood pressure within the normal range (90-130/60-80 mmHg).

Exclusion criteria

• History of cardiovascular, cerebrovascular, pulmonary, hepatic, dermatologic, or hematologic diseases.
• History of substance abuse.
• The use of medications or medical devices.
• Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

IH group

Active Comparator group

Description:

Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention before exposure to acute hypoxia environment.

Treatment:

Other: Intermittent Hypoxia

Control group

Sham Comparator group

Description:

Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days before exposure to acute hypoxia environment.

Treatment:

Other: Sham Intermittent Hypoxia