The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

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

Study Overview

• Status: Recruiting
• Conditions: Acute Mountain Sickness
• Intervention / Treatment: Other: Intermittent Hypoxia; Other: Sham Intermittent Hypoxia

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wang, M.D.; Phone Number: +86-135 8156 7815; Email: wilma0106@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Xunming Ji, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A noninvasive cranial pressure detector will be used to monitor the intracranial pressure.	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.	After the 6-hour acute hypoxia exposuring.

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: IH-AHI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No