Acute Mountain SicknessNCT06145113
The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
A study testing Continuous positive airway pressure (CPAP), ResMed AirMini in people with Acute Mountain Sickness, run by University of Colorado, Denver at 1 site in Nepal.
Trial summary
Acute Mountain Sickness (AMS) is a common condition affecting individuals traveling to elevations greater than 2500 meters (8200 feet). While more gradual ascent profiles, as well as the use of acetazolamide, have been shown to decrease the incidence of AMS, it remains a common condition that can affect anyone who… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- Continuous positive airway pressure (CPAP), ResMed AirMini
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNepal
- Study dates
- 10 Mar 2024to 10 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- present in Pheriche, Nepal;
- Lake Louise score > 1 (with or without formal AMS diagnosis)
Who cannot join
- History of chronic respiratory conditions (uncontrolled asthma, COPD, ILD)
- obstructive sleep apnea (if currently using nighttime CPAP)
- congestive heart failure
- coronary artery disease
- history of myocardial infarction
- neurologic disorder
Show all 12Show fewer
- cognitive disorder
- altered mental status
- pregnancy
- current use of supplemental oxygen
- excessive facial hair,
- claustrophobia
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Himalayan Rescue Association
Pheriche
Gobi Bashyal, +9779851033046, gobibashyal@gmail.com
Brian M Strickland, MD
About this study
Acute Mountain Sickness (AMS) is a common condition affecting individuals traveling to elevations greater than 2500 meters (8200 feet). While more gradual ascent profiles, as well as the use of acetazolamide, have been shown to decrease the incidence of AMS, it remains a common condition that can affect anyone who travels to altitude. Many pharmacologic options for treatment of AMS exist, however these are not always effective or able to be taken by all patients. Continuous positive airway pressure (CPAP) has been shown in some small studies and reports to be a potential non-pharmacologic method of both preventing and treating AMS. No large trials to validate the efficacy of CPAP in altitude related illness have been done. This study aims to evaluate the degree to which CPAP can improve symptoms of AMS, as well as improve oxygen saturation among individuals traveling in a high altitude location.
Read the detailed description
AMS is commonly experienced among travelers in all high altitude locations, and can affect anyone who travels to one of these places. This illness can be prevented, and after its symptoms have been started, can be treated with medication, as well as by descending to a lower elevation. The medications for AMS symptoms, including acetazolamide, dexamethasone, and ibuprofen are not always effective, and even when they are, often take considerable time to show their effect. Additionally, not all patients can take these medications. When these medications are not effective, or there is a contraindication to their use, descent to a lower elevation is necessary, however this is not always possible due to weather, debilitating symptoms, or coinciding diagnoses of high altitude pulmonary edema (HAPE) or high altitude cerebral edema (HACE). These situations require a difficult and complicated evacuation, requiring multiple rescuers and heavy equipment, or increased risk of clinical deterioration.
CPAP has been shown to be a potential non-pharmacologic method of both preventing and treating AMS. These limited studies quantified symptoms using the Lake Louise score {LLS}, a clinical tool used to assess the severity of AMS. They showed that LLS among subjects receiving CPAP, LLS lower when using it prophylactically or after AMS symptoms had started, however these were not compared against placebo. Additionally, over the last five years, CPAP devices have become quite portable and battery powered, making them much more suitable for travel to wilderness and high altitude locations. They are also available to consumers at low cost, are designed for travel and weigh less than 1 kg. Taking advantage of these devices' portability, a potential new treatment modality for AMS and other altitude related illnesses exists. Additionally, these devices can offer new solutions for mountain rescue and evacuation of patients suffering from altitude related illness, as these devices have been shown in a yet-to-be-published study to improve oxygen saturation and work of breathing while ambulating and self-carrying the device. Improvements in these assessments has been rapid (less than 2 minutes), potentially offering a more rapid treatment of AMS than existing pharmacologic agents as well. This study will be done in Pheriche, Nepal, as it is a location that has a uniquely elevated prevalence of altitude-related illness.
- Conditions
- Acute Mountain Sickness
- Being tested
- Continuous positive airway pressure (CPAP), ResMed AirMini
- Keywords
- Acute mountain sickness, Altitude, CPAP, Positive airway pressure
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressure (CPAP), ResMed AirMiniDevice
Consumer CPAP device, designed for use without medical supervision by patients with obstructive sleep apnea. This device is safely used by unconscious patients for several hours at a time. This will be supplied by face mask to awake patients under direct medical supervision.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure - 10cmH2O | Active comparator | This arm will consist of positive airway pressure at an FiO2 of 21% (ambient air), supplied by CPAP device set to 10cmH2O of pressure, for a total of 2 hours. Receives: Device: Continuous positive airway pressure (CPAP), ResMed AirMini |
| Placebo Continuous Positive Airway Pressure - 1cmH2O | Placebo comparator | This arm will consist of positive airway pressure at an FiO2 of 21% (ambient air), supplied by CPAP device set to 1cmH2O of pressure, for a total of 2 hours. This 1cmH2O is necessary to maintain blinding and will provide minimal therapeutic effect. Receives: Device: Continuous positive airway pressure (CPAP), ResMed AirMini |
| Continuous Positive Airway Pressure - 10cmH2O, with supplemental oxygen | Other | This arm will only be enrolled into once the other two arms have been completed. Additional subjects will receive CPAP at 10cmH2O with in-line oxygen (estimated 2-4 liters per minute). This is done to determine if adding supplemental oxygen can further improve symptoms. Receives: Device: Continuous positive airway pressure (CPAP), ResMed AirMini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lake Louise score for symptoms of acute mountain sickness
This is a validated set of criteria used for research purposes to quantify symptoms of acute mountain sickness.
A Lake Louise score greater than or equal to 3 is considered diagnostic of acute mountain sickness, and ranges from 0 to 15.
Higher Lake Louise scores are associated with more severe symptoms and level of disability.
The criteria are as follows:
Headache: 0-3 Gastrointestinal symptoms: 0-3 Fatigue and/or weakness: 0-3 Dizziness/light-headedness: 0-3 AMS Clinical Functional Score: 0-3
Measured: Prior to intervention, immediately following intervention, morning following intervention
Secondary outcomes (3)
Pulse oximetry
Level of peripheral oxygen saturation as measured by pulse oximeter (0-100%)
Measured: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Heart rate
Measured by palpation of peripheral pulses or pulse oximeter (beats per minute)
Measured: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Respiratory rate
Measured by observation of chest rise and fall (breaths per minute)
Measured: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start10 Mar 2024 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mountain SicknessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Himalayan Rescue Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145113
- Sponsor's protocol ID
- 23-2158
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness
- ClinicalTrials.gov ID
- NCT06145113
- Acronym / sponsor ID
- 23-2158
- Conditions
- Acute Mountain Sickness
- Keywords
- Acute mountain sickness, Altitude, CPAP, Positive airway pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Himalayan Rescue Association
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute Mountain Sickness (AMS) is a common condition affecting individuals traveling to elevations greater than 2500 meters (8200 feet). While more gradual ascent profiles, as well as the use of acetazolamide, have been shown to decrease the incidence of AMS, it remains a common condition that can affect anyone who travels to altitude. Many pharmacologic options for treatment of AMS exist, however these are not always effective or able to be taken by all patients. Continuous positive airway pressure (CPAP) has been shown in some small studies and reports to be a potential non-pharmacologic method of both preventing and treating AMS. No large trials to validate the efficacy of CPAP in altitude related illness have been done. This study aims to evaluate the degree to which CPAP can improve symptoms of AMS, as well as improve oxygen saturation among individuals traveling in a high altitude location.
Detailed description
AMS is commonly experienced among travelers in all high altitude locations, and can affect anyone who travels to one of these places. This illness can be prevented, and after its symptoms have been started, can be treated with medication, as well as by descending to a lower elevation. The medications for AMS symptoms, including acetazolamide, dexamethasone, and ibuprofen are not always effective, and even when they are, often take considerable time to show their effect. Additionally, not all patients can take these medications. When these medications are not effective, or there is a contraindication to their use, descent to a lower elevation is necessary, however this is not always possible due to weather, debilitating symptoms, or coinciding diagnoses of high altitude pulmonary edema (HAPE) or high altitude cerebral edema (HACE). These situations require a difficult and complicated evacuation, requiring multiple rescuers and heavy equipment, or increased risk of clinical deterioration.
CPAP has been shown to be a potential non-pharmacologic method of both preventing and treating AMS. These limited studies quantified symptoms using the Lake Louise score {LLS}, a clinical tool used to assess the severity of AMS. They showed that LLS among subjects receiving CPAP, LLS lower when using it prophylactically or after AMS symptoms had started, however these were not compared against placebo. Additionally, over the last five years, CPAP devices have become quite portable and battery powered, making them much more suitable for travel to wilderness and high altitude locations. They are also available to consumers at low cost, are designed for travel and weigh less than 1 kg. Taking advantage of these devices' portability, a potential new treatment modality for AMS and other altitude related illnesses exists. Additionally, these devices can offer new solutions for mountain rescue and evacuation of patients suffering from altitude related illness, as these devices have been shown in a yet-to-be-published study to improve oxygen saturation and work of breathing while ambulating and self-carrying the device. Improvements in these assessments has been rapid (less than 2 minutes), potentially offering a more rapid treatment of AMS than existing pharmacologic agents as well. This study will be done in Pheriche, Nepal, as it is a location that has a uniquely elevated prevalence of altitude-related illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure - 10cmH2O | Active comparator | Device: Continuous positive airway pressure (CPAP), ResMed AirMiniThis arm will consist of positive airway pressure at an FiO2 of 21% (ambient air), supplied by CPAP device set to 10cmH2O of pressure, for a total of 2 hours. |
| Placebo Continuous Positive Airway Pressure - 1cmH2O | Placebo comparator | Device: Continuous positive airway pressure (CPAP), ResMed AirMiniThis arm will consist of positive airway pressure at an FiO2 of 21% (ambient air), supplied by CPAP device set to 1cmH2O of pressure, for a total of 2 hours. This 1cmH2O is necessary to maintain blinding and will provide minimal therapeutic effect. |
| Continuous Positive Airway Pressure - 10cmH2O, with supplemental oxygen | Other | Device: Continuous positive airway pressure (CPAP), ResMed AirMiniThis arm will only be enrolled into once the other two arms have been completed. Additional subjects will receive CPAP at 10cmH2O with in-line oxygen (estimated 2-4 liters per minute). This is done to determine if adding supplemental oxygen can further improve symptoms. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- present in Pheriche, Nepal;
- Lake Louise score > 1 (with or without formal AMS diagnosis)
Key exclusion criteria (12 listed)
- History of chronic respiratory conditions (uncontrolled asthma, COPD, ILD)
- obstructive sleep apnea (if currently using nighttime CPAP)
- congestive heart failure
- coronary artery disease
- history of myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressure (CPAP), ResMed AirMiniConsumer CPAP device, designed for use without medical supervision by patients with obstructive sleep apnea. This device is safely used by unconscious patients for several hours at a time. This will be supplied by face mask to awake patients under direct medical supervision. | Device | Continuous Positive Airway Pressure - 10cmH2O, Continuous Positive Airway Pressure - 10cmH2O, with supplemental oxygen, Placebo Continuous Positive Airway Pressure - 1cmH2O |
Primary outcome
Lake Louise score for symptoms of acute mountain sickness
Time frame: Prior to intervention, immediately following intervention, morning following intervention
This is a validated set of criteria used for research purposes to quantify symptoms of acute mountain sickness. A Lake Louise score greater than or equal to 3 is considered diagnostic of acute mountain sickness, and ranges from 0 to 15. Higher Lake Louise scores are associated with more severe symptoms and level of disability. The criteria are as follows: Headache: 0-3 Gastrointestinal symptoms: 0-3 Fatigue and/or weakness: 0-3 Dizziness/light-headedness: 0-3 AMS Clinical Functional Score: 0-3
3 secondary outcomes
Pulse oximetry
Time frame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Heart rate
Time frame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Respiratory rate
Time frame: Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive airway pressure (CPAP), ResMed AirMini in people with Acute Mountain Sickness, run by University of Colorado, Denver at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian M Strickland, MD (9139619491, brian.strickland@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lake Louise score for symptoms of acute mountain sickness (time frame: Prior to intervention, immediately following intervention, morning following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.