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HypoxemiaNCT05971290

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

A study testing Continuous positive airway pressure and Ambient air in people with Hypoxemia and Altitude Hypoxia, run by University of Colorado, Denver at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxemia, Altitude Hypoxia
What is being tested?
Continuous positive airway pressure and Ambient air
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
22 Jul 2023to 1 Oct 2023
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

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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Denver

    Denver, Colorado, 80211

Other trials in United States

About this study

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.

Read more

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.

Being tested
Continuous positive airway pressure, Ambient air
Medical subject headings
Hypoxia, Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous positive airway pressureDevice

    Continuous positive airway pressure administered by face mask

  • Ambient airDevice

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

Study groups in NCT05971290
Study groupRoleWhat they receive
Continuous Positive Airway Pressure useExperimentalNot described
Receives: Device: Continuous positive airway pressure
Ambient airSham comparatorNot described
Receives: Device: Ambient air

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peripheral oxygen saturation

    SpO2 measurement in percentage

    Measured: 1 day

  2. Respiratory rate

    Breaths/minute

    Measured: 1 day

  3. Heart rate

    Heartbeats/minute

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start22 Jul 2023 (estimated)
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971290
Sponsor's protocol ID
23-0468
Status last verified
Jul 2023
First submitted
6 Jul 2023
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuous positive airway pressure and Ambient air in people with Hypoxemia and Altitude Hypoxia, run by University of Colorado, Denver at 1 site in United States.

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 17 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 2 Aug 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 United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral oxygen saturation (time frame: 1 day). The study lists 3 primary outcomes in all. 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 2 Aug 2023.

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