The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
Study Details
Study Description
Brief Summary
This study intends to further reveal the effectiveness of intermittent hypoxia in preventing acute hypoxic injury.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: IH group Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention before exposure to acute hypoxia environment. |
Other: Intermittent Hypoxia
The intermittent hypoxia protocol refers to four cycles of 10 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 5 days.
|
| Sham Comparator: Control group Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days before exposure to acute hypoxia environment. |
Other: Sham Intermittent Hypoxia
The sham intermittent hypoxia protocol refers to 55 minutes normoxia inhaling, which is performed twice a day (at least 6 hours apart) in 5 days.
|
Outcome Measures
Primary Outcome Measures
- Incidence of acute mountain sickness between IH group and control group [After the 6-hour acute hypoxia exposuring.]
A questionnaire called 2018 Lake Louise Scoring System (LLSS) score [0-12] will be used in this primary outcome assessment. The higher LLS scores mean the worse symptoms of acute mountain sickness (AMS).
Secondary Outcome Measures
- Concentration of serum parameters between IH group and control group [After the 6-hour acute hypoxia exposuring.]
- Incidence of intracranial hypertension between IH group and control group [After the 6-hour acute hypoxia exposuring.]
A noninvasive cranial pressure detector will be used to monitor the intracranial pressure.
- Incidence of decreased reaction and executive ability between IH group and control group [After the 6-hour acute hypoxia exposuring.]
Related questionnaires will be used to assess the relevant cognitive domain.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed written consent from the volunteers.
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Healthy volunteers between ages of 18 and 45 years, body mass index (BMI) of 19.0 and 24.9 kg/m2.
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Long-term residence at flatland (altitude of <100 m), not having been to an altitude ≥1500 m in 30 days.
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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:
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History of cardiovascular, cerebrovascular, pulmonary, hepatic, dermatologic, or hematologic diseases.
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History of substance abuse.
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The use of medications or medical devices.
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Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xuanwu Hospital, Capital Medical University | Beijing | China |
Sponsors and Collaborators
- Capital Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IH-AHI