NeurocognitionPhase 4SPIRIT_1NCT07651917
Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders
A Phase 4 study testing Supplemental oxygen therapy in people with Neurocognition, run by University of Zurich.
Trial summary
Exposure to high altitudes, defined as locations above 2500 m, has been shown to cause cognitive alternations due to reduced blood oxygenation (SpO2). However, it remains to be determined whether cognitive changes are present in highlanders living at moderate altitudes (2500 m) and whether cognitive alterations are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognition
- What is being tested?
- Supplemental oxygen therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 18 Jun 2026to 31 Jul 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed written consent
- Age >18
- Kyrgyz ethnicity
- Born, raised and living at approximately 2500 m
- Native or fluent in Russian language
Who cannot join
- Severe disease such as unstable hypertension, coronary heart disease, pulmonary diseases, others.
- Regular use of medication that interfere with sleep or breathing such as benzodiazepines, opioids, acetazolamide
- Heavy smoking of >20 cigarettes per day
- Not able to read or adhere to the study protocol
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Edith M Schneider, Dr. contact
About this study
Exposure to high altitudes, defined as locations above 2500 m, has been shown to cause cognitive alternations due to reduced blood oxygenation (SpO2). However, it remains to be determined whether cognitive changes are present in highlanders living at moderate altitudes (2500 m) and whether cognitive alterations are reversible with supplemental oxygen therapy (SOT).
- Conditions
- Neurocognition
- Being tested
- Supplemental oxygen therapy, Sham intervention
- Keywords
- Hypoxia, Altitude, Supplemental oxygen therapy
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemental oxygen therapyDrug
5 L/min supplemental oxygen therapy administered through nasal canula.
Sham interventionOther
5 L/min sham intervention administered through nasal canula.
| Study group | Role | What they receive |
|---|---|---|
| SOT followed by Sham intervention | Active comparator | 5L /min supplemental oxygen therapy through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min sham intervention (room air). Receives: Drug: Supplemental oxygen therapy; Other: Sham intervention |
| Sham intervention followed by SOT | Sham comparator | 5L /min sham intervention (room air) through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min supplemental oxygen therapy. Receives: Drug: Supplemental oxygen therapy; Other: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor vigilance reaction time
The difference in the reaction time during a 10-minute psychomotor vigilance test between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Secondary outcomes (8)
Trail making test performance
The difference in the trial making test A performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Stroop test performance
The difference in the stroop test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Digit Span test performance
The difference in the digit span test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Go / No-Go test performance
The difference in the Go / No-Go test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
N-back test performance
The difference in the n-back test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Task Switching Cued test performance
The difference in the task switching cued test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Flanker test performance
The difference in the Flanker test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Corsi Span test performance
The difference in the Corsi span test performance between SOT and Sham intervention.
Measured: Comparison between SOT and sham after 15 minutes intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start18 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurocognitionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Michael Furian, Principal investigator, University of ZurichEdith M Schneider, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651917
- Sponsor's protocol ID
- SPIRIT_1
- Acronym
- SPIRIT_1
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supplemental Oxygen Therapy on Neurocognitive Performance in Healthy Highlanders
- ClinicalTrials.gov ID
- NCT07651917
- Acronym / sponsor ID
- SPIRIT_1 / SPIRIT_1
- Conditions
- Neurocognition
- Keywords
- Hypoxia, Altitude, Supplemental oxygen therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 18 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 16 Jun 2026 (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.
Exposure to high altitudes, defined as locations above 2500 m, has been shown to cause cognitive alternations due to reduced blood oxygenation (SpO2). However, it remains to be determined whether cognitive changes are present in highlanders living at moderate altitudes (2500 m) and whether cognitive alterations are reversible with supplemental oxygen therapy (SOT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOT followed by Sham intervention | Active comparator | Drug: Supplemental oxygen therapy, Other: Sham intervention5L /min supplemental oxygen therapy through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min sham intervention (room air). |
| Sham intervention followed by SOT | Sham comparator | Drug: Supplemental oxygen therapy, Other: Sham intervention5L /min sham intervention (room air) through a nasal canula will be administered to the participants. The intervention will start 5 minutes before the neurocognitive assessments and will be administered throughout the assessment. After >4 hours of washout, the participants will repeat the neurocognitive assessments with 5 L/min supplemental oxygen therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed written consent
- Age >18
- Kyrgyz ethnicity
- Born, raised and living at approximately 2500 m
- Native or fluent in Russian language
Key exclusion criteria (4 listed)
- Severe disease such as unstable hypertension, coronary heart disease, pulmonary diseases, others.
- Regular use of medication that interfere with sleep or breathing such as benzodiazepines, opioids, acetazolamide
- Heavy smoking of >20 cigarettes per day
- Not able to read or adhere to the study protocol
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 |
|---|---|---|
| Supplemental oxygen therapy5 L/min supplemental oxygen therapy administered through nasal canula. | Drug | SOT followed by Sham intervention, Sham intervention followed by SOT |
| Sham intervention5 L/min sham intervention administered through nasal canula. | Other | SOT followed by Sham intervention, Sham intervention followed by SOT |
Primary outcome
Psychomotor vigilance reaction time
Time frame: Comparison between SOT and sham after 15 minutes intervention
The difference in the reaction time during a 10-minute psychomotor vigilance test between SOT and Sham intervention.
8 secondary outcomes
Trail making test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Stroop test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Digit Span test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Go / No-Go test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
N-back test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Task Switching Cued test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Flanker test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
Corsi Span test performance
Time frame: Comparison between SOT and sham after 15 minutes intervention
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 16 Jun 2026.
- 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.
Edith M Schneider, Dr. contact
Michael Furian principal investigator
University of Zurich
Edith M Schneider, Dr. principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supplemental oxygen therapy in people with Neurocognition, run by University of Zurich.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Michael Furian, Prof. Dr. (+41794037586, michael.furian@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor vigilance reaction time (time frame: Comparison between SOT and sham after 15 minutes 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 16 Jun 2026.