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The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Primary Purpose

Acute Mountain Sickness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intermittent Hypoxia
Sham Intermittent Hypoxia
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Mountain Sickness

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xuanwu Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

IH group

Control group

Arm Description

Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention before exposure to acute hypoxia environment.

Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days before exposure to acute hypoxia environment.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Concentration of serum parameters between IH group and control group
Incidence of intracranial hypertension between IH group and control group
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
Related questionnaires will be used to assess the relevant cognitive domain.

Full Information

First Posted
January 10, 2023
Last Updated
March 28, 2023
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05733338
Brief Title
The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
Official Title
The Effects of Intermittent Hypoxia on Acute Hypoxic Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Mountain Sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IH group
Arm Type
Active Comparator
Arm Description
Participants will receive 10 times intermittent hypoxia (oxygen concentration: 13%) intervention before exposure to acute hypoxia environment.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Participants will receive 10 times sham-hypoxia (oxygen concentration: 21%) intervention in 5 days before exposure to acute hypoxia environment.
Intervention Type
Other
Intervention Name(s)
Intermittent Hypoxia
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Intermittent Hypoxia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of acute mountain sickness between IH group and control group
Description
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.
Secondary Outcome Measure Information:
Title
Concentration of serum parameters between IH group and control group
Time Frame
After the 6-hour acute hypoxia exposuring.
Title
Incidence of intracranial hypertension between IH group and control group
Description
A noninvasive cranial pressure detector will be used to monitor the intracranial pressure.
Time Frame
After the 6-hour acute hypoxia exposuring.
Title
Incidence of decreased reaction and executive ability between IH group and control group
Description
Related questionnaires will be used to assess the relevant cognitive domain.
Time Frame
After the 6-hour acute hypoxia exposuring.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Wang, M.D.
Phone
+86-135 8156 7815
Email
wilma0106@163.com
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xunming Ji, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

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