The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

NCT05733338 | Unknown

• 1 other identifier: IH-AHI
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Incidence of decreased reaction and executive ability between IH group and control group

  After the 6-hour acute hypoxia exposuring.

Study Arms (2)

IH group

ACTIVE COMPARATOR

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

Other: Intermittent Hypoxia

Control group

SHAM COMPARATOR

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

Other: Sham Intermittent Hypoxia

Interventions

Intermittent Hypoxia OTHER

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.

IH group

Sham Intermittent Hypoxia OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Yuan Wang, M.D.

CONTACT

+86-135 8156 7815; wilma0106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 17, 2023
• Study Start: March 1, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)