Altitude Sickness
Conditions
Brief summary
This is a research study on Altitude Illness. From the information collected and studied in this project we hope to learn more about Altitude Illness, including factors that may affect and prevent the development and progression of this condition. We hope to learn if the commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude illness. Possible participants in this study are healthy adults who indicated they would like to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford University researchers hope to enroll about 100 participants.
Detailed description
This study was designed to bring together elements of prior studies and go one step further for definitive data on several points. The trial will employ two pharmaceutical intervention arms, which will compare placebo (the standard of care - information on prevention of altitude sickness) with the widely used NSAID ibuprofen. We will also determine Optic Nerve Sheath Diameter (ONSD) measurements via ultrasound in both the control and interventional arms. We will accomplish these objectives with a prospective, double blinded view of a large population of hikers who are ascending at their own rate in a true hiking environment: The White Mountain Research Station Owen Valley Lab (OVL) and Bancroft Station (BAR). Primary hypothesis: Ibuprofen 600 mg TID will be superior to placebo in decreasing both the incidence and severity of AMS in high altitude travel.
Interventions
DRUGIbuprofen
3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
DRUGPlacebo
identical number of visually identical tasteless pills as ibuprofen arm
Sponsors
University of California, San Diego
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Male or female volunteer 2. Age 18-65 3. Sea-level dwelling 4. Non pregnant 5. Have not been to high altitude in the past week 6. Can arrange for their own transportation to WMRS by friday evening the weekend of their study enrollment and are available the duration of the weekend of their study enrollment
Exclusion criteria
1. Age \<18 or \>65 2. Live at altitude \> Sea Level +/- 1000' 3. Pregnant 4. Taking NSAIDs, Acetazolamide, or Corticosteroids 5. Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past 6. Traveled or planning to travel to high altitude in the week prior to their enrollment. 7. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri, ventricular shunts, loss of an eye, Asthma, HACE or HAPE. 8. Cannot arrange for their own transportation to WMRS or are unavailable for the duration of the weekend of their study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Mountain Sickness | 2 days | Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness |
| Acute Mountain Sickness Severity | 2 days | Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total) | 44 |
| Placebo Visually identical placebo | 42 |
| Total | 86 |
Baseline characteristics
| Characteristic | Ibuprofen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 42 Participants | 86 Participants |
| Age, Continuous | 38.4 years STANDARD_DEVIATION 14.5 | 34.2 years STANDARD_DEVIATION 13.2 | 36.6 years STANDARD_DEVIATION 13.9 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 30 Participants | 28 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 42 |
| serious Total, serious adverse events | 0 / 47 | 0 / 42 |
Outcome results
Primary
Acute Mountain Sickness
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms; scores of 3 or greater with presence of a headache considered a positive diagnosis of acute mountain sickness
Time frame: 2 days
Population: Participants meeting all inclusion criteria were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen | Acute Mountain Sickness | 19 Participants |
| Placebo | Acute Mountain Sickness | 26 Participants |
Primary
Acute Mountain Sickness Severity
Lake Louise Criteria scores range from 0-15 with higher scores representing more severe symptoms
Time frame: 2 days
Population: Participants meeting all inclusion criteria were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibuprofen | Acute Mountain Sickness Severity | 3.2 units on a scale | Standard Deviation 2.4 |
| Placebo | Acute Mountain Sickness Severity | 4.4 units on a scale | Standard Deviation 2.6 |