Acute Mountain SicknessNCT07126834
Voluntary Isocapnic Hyperpnea in Hypoxia to Mitigate Acute Mountain Sickness
A study testing VIH in people with Acute Mountain Sickness, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
Trial summary
This study investigates the effects of a brief Voluntary Isocapnic Hyperpnoea (VIH) on Acute Mountain Sickness (AMS) symptoms, SpO₂, blood pressure, and blood gas homeostasis in normobaric hypoxia, to evaluate whether such respiratory modulation may serve as a viable strategy to alleviate AMS symptoms. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Mountain Sickness
- What is being tested?
- VIH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- exposure to hypoxia within the past three months,
- any chronic or acute medical condition within the same timeframe,
- current use of any medication,
- known allergic reactions,
- pregnancy,
- smoking.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Institute of Sport - National Research Institute, Warsaw, Poland
Warsaw, 01-982
About this study
Official title: Could a Breathing Protocol Serve as a Non-Pharmacological Strategy to Mitigate Acute Mountain Sickness? A Randomized Crossover Trial.
This study investigates the effects of a brief Voluntary Isocapnic Hyperpnoea (VIH) on Acute Mountain Sickness (AMS) symptoms, SpO₂, blood pressure, and blood gas homeostasis in normobaric hypoxia, to evaluate whether such respiratory modulation may serve as a viable strategy to alleviate AMS symptoms. The investigation seeks to explore the physiological mechanisms underlying VIH in severe hypoxia (4200m asl) and furnish insight regarding practical means of providing immediate relief from AMS symptoms. Furthermore, given the scarcity of relevant literature, this investigation may serve as a pilot study and lay the foundation for future research.
The present investigation employed a randomized crossover design. The study was conducted in the Institute of Sport - National Research Institute in Warsaw, Poland, in July and August 2025. Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. The order of sessions was determined using block randomization within subgroups of 4-6 individuals to ensure balanced exposure to each condition. Multiple measurements were taken, including blood pressure, heart rate, SpO2, blood gasometry, and the 2018 Lake Louise AMS Score.
Read the detailed description
Blood gas analysis was conducted using a Radiometer™ ABL90 FLEX (Radiometer Medical ApS, Brønshøj, Denmark). The following parameters were assessed: hydrogen ion concentration (pH), bicarbonate ion concentration (HCO₃-), partial pressure of oxygen (pO₂), and partial pressure of carbon dioxide (pCO₂). All measurements were taken in duplicate using 45 µL capillary blood samples collected from the fingertip. Analyses were performed immediately following collection by a trained technician following the manufacturer's instructions.
Peripheral blood pressure was measured digitally using the OMRON M2 monitor (OMRON Healthcare, Kyoto, Japan).
SpO₂ was estimated at the fingertip using a pulse oximeter (NONIN Onyx Vantage 9590, Nonin Medical, Inc., Plymouth, MN, USA).
The 2018 Lake Louise AMS Score questionnaire was presented to the participants before the experiment for familiarization and then used to evaluate symptoms of AMS based on a combination of subjective self-reports and clinical findings.
All the measurements were performed by qualified and experienced specialists. The participants were blinded to the obtained results, except for the 2018 Lake Louise AMS Score, which was self-reported.
- Conditions
- Acute Mountain Sickness
- Being tested
- VIH
- Keywords
- acute mountan sickness, breathing, hyperpnoea, blood gas analysis, lake louis scale
- Medical subject headings
- Altitude Sickness, Respiratory Aspiration, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIHBehavioural
During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. |
| Experimental | Experimental | Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. Receives: Behavioral: VIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO₂
Arterial oxygen saturation (SpO₂)
Measured: Day 1 and Day 2 of the study.
AMS LL
2018 Lake Louise Acute Mountain Sickness Score
Measured: Day 1 and Day 2 of the study.
pH
hydrogen ion concentration
Measured: Day 1 and Day 2 of the study.
pO₂
partial pressure of oxygen (pO₂)
Measured: Day 1 and Day 2 of the study.
pCO₂
partial pressure of carbon dioxide (pCO₂)
Measured: Day 1 and Day 2 of the study.
HCO₃-
bicarbonate ion concentration (HCO₃-)
Measured: Day 1 and Day 2 of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Jun 2025
- Primary completion15 Jun 2025
- Study completion31 Aug 2025 (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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Sport - National Research Institute, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Kowalski, Institute of Sport - National Research Institute, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126834
- Sponsor's protocol ID
- 2025/TK/1
- Other IDs
- 102.39/2025
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy reasons.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could a Breathing Protocol Serve as a Non-Pharmacological Strategy to Mitigate Acute Mountain Sickness? A Randomized Crossover Trial.
- ClinicalTrials.gov ID
- NCT07126834
- Acronym / sponsor ID
- 2025/TK/1
- Conditions
- Acute Mountain Sickness
- Keywords
- acute mountan sickness, breathing, hyperpnoea, blood gas analysis, lake louis scale
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Sport - National Research Institute, PolandUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Aug 2025 (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.
This study investigates the effects of a brief Voluntary Isocapnic Hyperpnoea (VIH) on Acute Mountain Sickness (AMS) symptoms, SpO₂, blood pressure, and blood gas homeostasis in normobaric hypoxia, to evaluate whether such respiratory modulation may serve as a viable strategy to alleviate AMS symptoms. The investigation seeks to explore the physiological mechanisms underlying VIH in severe hypoxia (4200m asl) and furnish insight regarding practical means of providing immediate relief from AMS symptoms. Furthermore, given the scarcity of relevant literature, this investigation may serve as a pilot study and lay the foundation for future research.
The present investigation employed a randomized crossover design. The study was conducted in the Institute of Sport - National Research Institute in Warsaw, Poland, in July and August 2025. Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. The order of sessions was determined using block randomization within subgroups of 4-6 individuals to ensure balanced exposure to each condition. Multiple measurements were taken, including blood pressure, heart rate, SpO2, blood gasometry, and the 2018 Lake Louise AMS Score.
Detailed description
Blood gas analysis was conducted using a Radiometer™ ABL90 FLEX (Radiometer Medical ApS, Brønshøj, Denmark). The following parameters were assessed: hydrogen ion concentration (pH), bicarbonate ion concentration (HCO₃-), partial pressure of oxygen (pO₂), and partial pressure of carbon dioxide (pCO₂). All measurements were taken in duplicate using 45 µL capillary blood samples collected from the fingertip. Analyses were performed immediately following collection by a trained technician following the manufacturer's instructions.
Peripheral blood pressure was measured digitally using the OMRON M2 monitor (OMRON Healthcare, Kyoto, Japan).
SpO₂ was estimated at the fingertip using a pulse oximeter (NONIN Onyx Vantage 9590, Nonin Medical, Inc., Plymouth, MN, USA).
The 2018 Lake Louise AMS Score questionnaire was presented to the participants before the experiment for familiarization and then used to evaluate symptoms of AMS based on a combination of subjective self-reports and clinical findings.
All the measurements were performed by qualified and experienced specialists. The participants were blinded to the obtained results, except for the 2018 Lake Louise AMS Score, which was self-reported.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Across 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the control session, the participants remained seated without any activity. |
| Experimental | Experimental | Behavioral: VIHAcross 2 consecutive days, the participants underwent two 2-hour sessions under hypoxia of 4200m asl (FiO2 = 12.8%) in a normobaric chamber (Air Sport, Międzyzdroje, Poland). The sessions were held at the same time of day, between 17:00 and 19:00. Temperature (approximately 21 °C), humidity (45-50%), and gas concentration were centrally controlled and maintained at stable levels throughout the exposure period. During the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- exposure to hypoxia within the past three months,
- any chronic or acute medical condition within the same timeframe,
- current use of any medication,
- known allergic reactions,
- pregnancy,
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 |
|---|---|---|
| VIHDuring the experimental session, they additionally performed a 5-minute VIH session (20 breaths/minute) after 1 hour of hypoxic exposure. Isocapnic BreathWayBetter devices (Isocapnic Technologies Inc., Kelowna, British Columbia, Canada) equipped with 6-liter breathing bags were employed to perform VIH. The accompanying Isocapnic mobile app was used to guide breathing rhythm and monitor session duration. | Behavioural | Experimental |
Primary outcome
SpO₂
Time frame: Day 1 and Day 2 of the study.
Arterial oxygen saturation (SpO₂)
AMS LL
Time frame: Day 1 and Day 2 of the study.
2018 Lake Louise Acute Mountain Sickness Score
pH
Time frame: Day 1 and Day 2 of the study.
hydrogen ion concentration
pO₂
Time frame: Day 1 and Day 2 of the study.
partial pressure of oxygen (pO₂)
pCO₂
Time frame: Day 1 and Day 2 of the study.
partial pressure of carbon dioxide (pCO₂)
HCO₃-
Time frame: Day 1 and Day 2 of the study.
bicarbonate ion concentration (HCO₃-)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. Privacy reasons.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIH in people with Acute Mountain Sickness, run by Institute of Sport - National Research Institute, Poland at 1 site in Poland.
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 0 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. 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 Poland. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
SpO₂ (time frame: Day 1 and Day 2 of the study.). The study lists 6 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 20 Aug 2025.