search
Back to results

Breathing Training to Improve Human Performance at High Altitude

Primary Purpose

Mountain Sickness Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Respiratory Muscle Training
Sham Breathing Training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mountain Sickness Acute focused on measuring Exercise, Aerobic, Cognitive Function

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Altitude Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Respiratory Muscle Training

Sham Breathing Training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Change in cognitive function during acute simulated high-altitude exposure as measured by the DANA cognitive test battery.
Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session improves cognitive function during simulated high-altitude exposure.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2018
Last Updated
April 15, 2022
Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT03530163
Brief Title
Breathing Training to Improve Human Performance at High Altitude
Official Title
Breathing Training to Improve Human Performance at High Altitude
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mountain Sickness Acute
Keywords
Exercise, Aerobic, Cognitive Function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be masked from knowing whether they are performing the Respiratory Muscle Training or sham training.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory Muscle Training
Arm Type
Experimental
Arm Title
Sham Breathing Training
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Respiratory Muscle Training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Breathing Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Title
Change in cognitive function during acute simulated high-altitude exposure as measured by the DANA cognitive test battery.
Description
Determine whether Respiratory Muscle Training performed 3x a week for 30 minutes per session improves cognitive function during simulated high-altitude exposure.
Time Frame
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)
Title
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).
Description
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.
Time Frame
Baseline and during acute simulated high-altitude exposure. (2 days, 12 hours per day)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Roach, PhD
Organizational Affiliation
Director, Altitude Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altitude Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Breathing Training to Improve Human Performance at High Altitude

We'll reach out to this number within 24 hrs