An interventional study of Intermittent Hypoxia and Sham Intermittent Hypoxia in Acute Mountain Sickness, sponsored by Capital Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Capital Medical University · Not applicable, Interventional, and Prevention
This study intends to further reveal the effectiveness of intermittent hypoxia in preventing acute hypoxic injury.
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.
189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 33 across 157 interventional studies indexed under Altitude Sickness.
Browse Altitude Sickness studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention before exposure to acute hypoxia environment.
Other: Intermittent Hypoxia
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 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.
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.
Incidence of acute mountain sickness between IH group and control group
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).
Time frame: After the 6-hour acute hypoxia exposuring.
Concentration of serum parameters between IH group and control group
Time frame: After the 6-hour acute hypoxia exposuring.
Incidence of intracranial hypertension between IH group and control group
A noninvasive cranial pressure detector will be used to monitor the intracranial pressure.
Time frame: After the 6-hour acute hypoxia exposuring.
Incidence of decreased reaction and executive ability between IH group and control group
Related questionnaires will be used to assess the relevant cognitive domain.
Time frame: After the 6-hour acute hypoxia exposuring.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Capital Medical University