The Effect of Continuous Positive Pressure Ventilation on Symptoms of Acute Mountain Sickness

NCT06145113 | Unknown DMC

• 1 other identifier: 23-2158
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Mountain Sickness

Keywords

Acute mountain sickness; Altitude; CPAP; Positive airway pressure

Outcome Measures

Primary Outcomes (1)

• 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

  Prior to intervention, immediately following intervention, morning following intervention

Secondary Outcomes (3)

• Pulse oximetry

  Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention

• Heart rate

  Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention

• Respiratory rate

  Prior to intervention, continuously while receiving intervention, immediately following intervention, morning following intervention

Study Arms (3)

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.

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.

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.

Device: Continuous positive airway pressure (CPAP), ResMed AirMini

Interventions

Continuous positive airway pressure (CPAP), ResMed AirMini DEVICE

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.

Continuous Positive Airway Pressure - 10cmH2O; Continuous Positive Airway Pressure - 10cmH2O, with supplemental oxygen; Placebo Continuous Positive Airway Pressure - 1cmH2O

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• present in Pheriche, Nepal;
• Lake Louise score \> 1 (with or without formal AMS diagnosis)

You may not qualify if:

• 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
• cognitive disorder
• altered mental status
• pregnancy
• current use of supplemental oxygen
• excessive facial hair,
• claustrophobia

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Himalayan Rescue Association: collaborator

Study Sites (1)

Himalayan Rescue Association

Pheriche, Nepal

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Brian M Strickland, MD

CONTACT

9139619491; brian.strickland@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each participant will not be aware of which arm to which they have been assigned. The on-site investigator will be responsible for randomization, so they will not be able to be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 22, 2023
• Study Start: March 10, 2024
• Primary Completion: June 10, 2024
• Study Completion: August 10, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

NE (1)