The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Acute Mountain Sickness Clinical Trial

Official title:

The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05733338
• Other study ID #: IH-AHI
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Capital Medical University
• Contact: Yuan Wang, M.D.
• Phone: +86-135 8156 7815
• Email: wilma0106[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Mountain Sickness
• Altitude Sickness
• Hypoxia

Intervention

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 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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	After the 6-hour acute hypoxia exposuring.
Secondary	Concentration of serum parameters between IH group and control group		After the 6-hour acute hypoxia exposuring.
Secondary	Incidence of intracranial hypertension between IH group and control group	A noninvasive cranial pressure detector will be used to monitor the intracranial pressure.	After the 6-hour acute hypoxia exposuring.
Secondary	Incidence of decreased reaction and executive ability between IH group and control group	Related questionnaires will be used to assess the relevant cognitive domain.	After the 6-hour acute hypoxia exposuring.