Breathing Training to Improve Human Performance at High Altitude

April 15, 2022 updated by: University of Colorado, Denver
Individuals traveling to altitudes above 8,000 feet may suffer from impaired exercise and cognitive performance, and acute mountain sickness (AMS). Decreased barometric pressure, which leads to low blood oxygen levels, is the primary cause of these disorders. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue, and difficulty sleeping. The goal of this research is to identify whether Respiratory Muscle Training will improve physical and cognitive performance, and reduce the symptoms of AMS, at simulated high altitude.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Aurora, Colorado, United States, 80045
        • Altitude Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy
  • Men, ages 18-45 who are able to achieve at least 3.5 watts/kg of body weight during the peak oxygen uptake test

Exclusion Criteria:

  • Less than 18 years old
  • Greater than 45 years old
  • Have a body mass index greater than or equal to 30
  • Have been recent smokers (tobacco or e-cigarettes)
  • Current recreational or medical marijuana users
  • Currently taking any medication (over-the-counter or prescription) or herbal supplements
  • Participants who are unable to tolerate drinking only two, 6-ounce caffeinated beverages per day of the study
  • Participants who are legally blind
  • Participants who have been to altitudes above Denver (1609m or 5280ft), including air travel, in the 3 weeks prior to the start of the study or with plans to do so during the study
  • Participants who have suffered a significant head injury, have anemia or sickle cell trait or disease, have active peptic ulcer disease, diabetes, hypertension, heart disease, HIV/AIDS, glaucoma, kidney disease, liver disease/cirrhosis, adrenal gland failure, hyponatremia/hypokalemia, tuberculosis
  • Participants who have a current herpes infection or any other current type of viral or bacterial infection
  • Participants with seizure disorders or history of migraines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory Muscle Training
Subjects will breathe through a custom isocapnic Respiratory Muscle Training method developed in-house. The initial breathing frequency will be 30 breaths per minute. Subsequent sessions will begin with 20 minutes of breathing at the highest rate attained on the previous training day. During the last 10 minutes of each session, breathing rate will increase by 1-2 breaths/min.
Sham Comparator: Sham Breathing Training
Each subject in the sham group will be prompted to hold his breath for 10 seconds every 30 seconds (two times each minute) while breathing on a circuit visibly identical to that used in Respiratory Muscle Training. The subject will breathe ambient air normally after each breath hold. Each sham session will last 30 minutes total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in exercise performance during acute simulated high-altitude exposure as measured by a peak oxygen uptake test and time to complete a 720kJ (40km) time trial on a Velotron cycle ergometer.
Time Frame: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session is effective in improving exercise performance during acute simulated high-altitude exposure.
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Change in cognitive function during acute simulated high-altitude exposure as measured by the DANA cognitive test battery.
Time Frame: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session improves cognitive function during simulated high-altitude exposure.
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Change in incidence and severity of acute mountain sickness during acute simulated high-altitude exposure as determined by the Lake Louise Questionnaire (a diagnostic survey of acute mountain sickness).
Time Frame: Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session is effective in reducing incidence and severity of AMS during acute simulated high-altitude exposure.
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Roach, PhD, Director, Altitude Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2018

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 18-0464

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mountain Sickness Acute

Clinical Trials on Respiratory Muscle Training

3
Subscribe