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Enrolling by invitationNCT05971290Updated Aug 2, 2023

Effects of Continuous Positive Airway Pressure on Peripheral Oxygen Saturation, Work of Breathing, and Exercise Tolerance at Altitude

An interventional study of Continuous positive airway pressure and Ambient air in Hypoxemia and Altitude Hypoxia, sponsored by University of Colorado, Denver. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Dyspnea and exercise intolerance are well known to travelers who have experienced time at high elevations, greater than 2500 meters (8200 feet). As individuals ascend to higher elevations, oxygen saturations significantly decrease as the partial pressure of oxygen decreases. Additionally, many individuals develop subclinical cases of high altitude pulmonary edema (HAPE), which may worsen hypoxemia and decrease exercise performance. While dyspnea and exercise intolerance are usually self-limiting and improve with rest, some individuals experience severe symptoms that prevent safe evacuation to lower elevation.

Individuals experiencing high altitude dyspnea, subclinical HAPE, or clinical HAPE will see improvements in symptoms and SpO2 when receiving supplemental oxygen, however this requires heavy and unwieldy tanks that make it difficult to carry across irregular terrain. Additionally, given the often-remote conditions where supplemental oxygen is needed, it is often difficult to replenish supplies. Other devices, such as the portable hyperbaric chamber (often referred to as Gamow bag), can temporarily improve dyspnea and oxygen saturation at high and extreme altitudes without the use of oxygen tanks. This device also carries some of the same disadvantages as supplemental oxygen, however, as the bag is also heavy and patients are not ambulatory while using the device.

Similar to supplemental oxygen and the portable hyperbaric chamber, there is some evidence that CPAP may improve SpO2 and dyspnea at high and extreme altitudes. CPAP has already demonstrated significant efficacy in reducing symptoms of acute mountain sickness (AMS) when used in the field. At the time these small studies were conducted, CPAP therapy carried similar disadvantages in weight and portability. In recent years, however, CPAP devices have become increasingly lightweight and portable, with recent models weighing less than 1 kilogram (2.2 pounds). These devices are often powered by batteries, which themselves are light and easy to carry, and can be charged in the field using either a generator or foldable solar panels. These newer features of CPAP devices overcome some of the previous disadvantages that have limited its potential uses. CPAP devices can easily be carried across difficult terrain directly to individuals suffering from altitude-related symptoms, to be used as a rescue device until definitive care is available. Its portability not only allows for easy delivery to a patient, but also may allow for a patient to experience enough symptom relief to walk themselves down to lower elevation, greatly improving speed and resource utilization involved in high altitude rescues.

In previous studies, CPAP devices have been found to be effective and safe to use in high and extreme altitude locations. While a few pilot studies have assessed CPAP's utility in treating dyspnea and SpO2 at altitude, these studies were done at rest. While one study showed improved symptoms and SpO2 in normobaric and hypobaric hypoxia, the study was limited by its lack of real-world condition, and its authors suggested further study in field and extreme environmental conditions. Additional investigation is needed to determine whether or not CPAP is an effective tool in the field to improve SpO2, dyspnea, and exercise tolerance in individuals traveling at high elevations.

02

Conditions studied

  • Hypoxemia
  • Altitude Hypoxia
03

In context

Altitude Sickness

189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.

This study's planned enrollment of 25 is below the median of 33 across 157 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults (age 18-70)
  • Living at lower elevation (\<2500m or 8200ft)

Exclusion criteria

Exclusion Criteria:

  • Age > 70 or age \< 18.
  • History of chronic respiratory conditions (asthma, COPD, ILD)
  • Obstructive sleep apnea (if currently using nighttime CPAP)
  • Congestive heart failure, coronary artery disease
  • History of myocardial infarction
  • History of HAPE
  • Neurologic disorder
  • Cognitive disorder
  • Altered mental status
  • Pregnancy
  • Current use of supplemental oxygen
  • Impaired mobility
  • Excessive facial hair
  • Claustrophobia.
  • Current use of altitude-related illness prophylaxis medications
  • Current use of anticoagulant medications
  • Current use of calcium channel blockers medications
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Continuous Positive Airway Pressure use

    Device: Continuous positive airway pressure

  • Sham comparator
    Ambient air

    Device: Ambient air

Interventions

  • DeviceContinuous positive airway pressure

    Continuous positive airway pressure administered by face mask

  • DeviceAmbient air

    Air (fraction of inspired oxygen) at 14000 feet in elevation

06

What researchers measure

Primary outcomes

  1. Peripheral oxygen saturation

    SpO2 measurement in percentage

    Time frame: 1 day

  2. Respiratory rate

    Breaths/minute

    Time frame: 1 day

  3. Heart rate

    Heartbeats/minute

    Time frame: 1 day

07

Study locations

1 site
  • University of Colorado Denver
    Denver, Colorado 80211, United States
08

References and documents

Study documents

  • Informed consent form · Apr 28, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05971290
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Aug 2, 2023
Start date
Jul 22, 2023 (estimated)
Primary completion
Oct 1, 2023 (estimated)
Completion
Oct 1, 2023 (estimated)
Last update
Aug 2, 2023

Study contacts

Brian M Strickland, MD
principal investigator · UC Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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