Clinical trial NCT05733338: The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
Official title: The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Mountain Sickness
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of acute mountain sickness between IH group and control group
timeFrame: After the 6-hour acute hypoxia exposuring.
Secondary outcomes:
measure: Concentration of serum parameters between IH group and control group
timeFrame: After the 6-hour acute hypoxia exposuring.
measure: Incidence of intracranial hypertension between IH group and control group
timeFrame: After the 6-hour acute hypoxia exposuring.
measure: Incidence of decreased reaction and executive ability between IH group and control group
timeFrame: After the 6-hour acute hypoxia exposuring.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: