Skip to main content
OpenTrials
Completed

NCT Number: NCT02463357

Three New Ideas to Protect Special Forces From the Stress of High Altitude

Acute Mountain Sickness (AMS) is a well-documented syndrome that affects 42% of non-acclimatized individuals traveling to altitudes above 10,000 feet. Decreased barometric pressure, which leads to low blood oxygen levels, is the primary casual factor of AMS. Symptoms of AMS are characterized by headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping. Moreover, when people travel to high altitude, cognitive performance and endurance exercise capacity are impaired. Therefore, the goal of this research is to identify effective pharmacological agents that will help reduce the symptoms of AMS and improve physical and cognitive performance at high altitude.

The investigators will study the efficacy of the dietary supplement, quercetin, the drugs nifedipine (extended release) and methazolamide taken together, the drug metformin, and the drug nitrite in reducing symptoms of AMS and improving cognitive and exercise performance at high altitudes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mountain Sickness Altitude Sickness Behavior Motor Activity Respiration Disorders Respiratory Tract Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Alma College

Alma, Michigan, 48801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy,
  • young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in < 15 min 54 s)

Exclusion criteria

  • women;
  • smokers;
  • participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
  • participants with a history of significant head injury, migraines or seizures;
  • participants taking any medication (over-the-counter or prescription) or herbal supplements;
  • participants with known flavonoid allergies;
  • participants with known allergies to metformin;
  • participants with known hypersensitivity reaction to nifedipine;
  • participants with known allergies to sulfonamide-based drugs;
  • participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
  • exposure to high altitude above 1000m in the previous three months; or
  • participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
  • participants who are unable to achieve the minimum physical criteria required for SOF training

Treatment and study plan

Quercetin

Dietary Supplement

Nifedipine extended release

Drug

Methazolamide

Drug

metformin

Drug

Placebo

Drug

Nitrite

Drug

Primary outcomes

  1. Change in Environmental Symptoms Questionnaire at High Altitude

    Time frame: Baseline and during high altitude exposure (3 days, AM/PM)

    Self-reported assessment of AMS symptoms (headache, lightheaded, dizzy, etc.). The 11-item Environmental Symptoms Questionnaire measures Acute Mountain Sickness symptoms (nausea, weakness, lightheadedness, dizziness, headache, etc.). Possible scores range from 0 to 55 (0-5 per item), with higher scores indicating a better outcome.

  2. Change in Lake Louise AMS Scoring System at High Altitude

    Time frame: Baseline and during high altitude exposure (3 days, AM/PM)

    Self-reported assessment of AMS symptoms (headache, nausea, vomiting, dizziness, fatigue and difficultly sleeping). The Lake Louise AMS Scoring System measures symptoms of altitude sickness. Possible scores range from 0 to 16, with higher scores indicating a worse outcome.

  3. Change in Army Physical Fitness Test (APFT) at High Altitude

    Time frame: Baseline, 1st day at high altitude

    Timed 2 mile run, push-ups, sit-ups, and pull-ups. The Army Physical Fitness Test (APFT) measures physical fitness. Higher scores indicate a better outcome. A score of 60 is considered minimum "passing" score. The maximum possible score is 300, indicating the highest level of physical fitness.

  4. Change in Uphill Hike at High Altitude

    Time frame: 2nd day at altitude

    Timed 3.1 mile uphill run/hike, with weighted back-pack

  5. Change in Defense Automated Neurobehavioral Assessment (DANA) Reaction Time at High Altitude

    Time frame: Baseline and and 1st day at high altitude

    Battery of nine cognitive function tests. The Defense Automated Neurobehavioral Assessment (DANA) measures cognitive function and was used to measure mean reaction time. Possible scores range from 180 to 500 milliseconds, with lower scores indicating a better outcome.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Alma College

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2015
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.