Breathing Training to Improve Human Performance at High Altitude

NCT ID: NCT03530163

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-09
• Study Completion Date: 2020-01-15

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.

Conditions

Mountain Sickness Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Respiratory Muscle Training

Group Type: EXPERIMENTAL

Respiratory Muscle Training

Intervention Type: DEVICE

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 Breathing Training

Group Type: SHAM_COMPARATOR

Sham Breathing Training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Roach, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Altitude Research Center

Locations

Altitude Research Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

18-0464

Identifier Type: -

Identifier Source: org_study_id