HypoxiaPsychoxieNCT05323864
Going to Altitude With Anxious-depressive Symptoms
A study testing Hypoxia in people with Hypoxia and Mental Disorder, run by Universitaet Innsbruck at 1 site in Austria.
Trial summary
Introduction: Currently, there is a lack of international guidelines or clinical recommendations for individuals with mental illnesses (i.e., bipolar disorder, posttraumatic stress disorder) going on high altitude sojourns. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Mental Disorder
- What is being tested?
- Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteAustria
- Study dates
- 14 Apr 2023to Dec 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- sufficient command of the German language
- no psychotic or cognitive disorders
- patients suffering from anxious-depressive symptoms (meeting the cut off points of light-medium in the screening for anxiety and depression symptoms)
Who cannot join
- pregnant or breastfeeding
- permanent residence above 1000m
- overnight stays at altitudes above 2500m in the previous month
- exposure to 2500m or higher two weeks prior to the six-hour hypoxic exposure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
University of Innsbruck, Department of Sport Science
Innsbruck, Tyrol, 6020
Linda Rausch, PhD, +4351250745851, linda.rausch@uibk.ac.at
About this study
Official title: Going to Altitude With Anxious-depressive Symptoms - a Randomised Cross Over Trial in Individuals With Mental Disorders and Healthy Controls
Introduction: Currently, there is a lack of international guidelines or clinical recommendations for individuals with mental illnesses (i.e., bipolar disorder, posttraumatic stress disorder) going on high altitude sojourns. However, these guidelines would be important considering that mental illnesses are among the most common disorders worldwide and millions of people are hiking at high altitudes in the Alps, being granted easy access up to 3800m by cable cars. Before conceptualizing these guidelines, it seems necessary to study the physiological and psychological effects of ambient pressure changes leading to oxygen deficiency (hypoxia) in individuals with mental illnesses when being exposed to hypoxic conditions. The investigators hypothesize a shift towards negative affective responses and state anxiety as well as increased levels of neurotransmitter precursor amino acids (PHE/TYR and KYN/TRP) in individuals with mental illnesses when being exposed to hypoxic conditions.
Methods and Analysis: The investigators plan to perform a double-blind randomized controlled trial in a safe laboratory environment by using a normobaric hypoxic chamber. Participants suffering from depression and anxiety symptoms will be included as well as age and sex-matched healthy controls. They will attend a six-hour exposure equivalent to 3800m of altitude as well as a six-hour exposure to sham hypoxic conditions. Recruited participants will be screened by the Beck Anxiety and Depression Inventory, the Symptom Checklist (SCL-90) as well as an interview assessment. Affective responses in state anxiety will be assessed before, and during each hour of exposure by using the Feeling Scale (FS), Felt Arousal Scale (FAS), Positive and Negative Affect Schedule (PANAS), State-Anxiety Inventory (STAI) and subjective mental stress levels (Visual Analogue Scale; VAS). Physiological parameters will be assessed by venous blood sampling, pulse oximetry and oxidative stress level measurement before entering the chamber, after three and six hours of exposure. Additionally, symptoms of acute mountain sickness will be assessed by the Lake Louise Score before, after three and six hours of exposure. Follow-up measurements are planned one and seven days after the chamber visit, consisting of venous blood sampling, the Beck Anxiety and Depression Inventory.
Read more
A series of univariate analyses of covariance (ANCOVA) for repeated measures will be used to test the three-way (i.e. "group × condition × time") and two-way ("group × condition" and "group × time") interactions. Analyses will be adjusted for possible confounding, by adding age, sex, smoking, prior AMS, and medication status in the models as covariates.
Ethics and dissemination: Ethical approval has been obtained from the ethics committee of the Medical University of Innsbruck (1250/2021).
- Conditions
- Hypoxia, Mental Disorder
- Being tested
- Hypoxia
- Keywords
- anxiety, depressive symptoms, high altitude
- Medical subject headings
- Hypoxia, Mental Disorders, Anxiety Disorders, Depression, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypoxiaBiological
Participants will be randomly assigned to start with the normobaric hypoxia condition or the sham hypoxia condition. They will swap to the other condition during the second visit, which will be executed at least 14 days after the first visit. Each sojourn will last for six hours and participants will reside in the chamber individually. During the six-hour stay, participants will be allowed to move freely within the chamber.
| Study group | Role | What they receive |
|---|---|---|
| Normobaric hypoxia | Experimental | Normobaric hypoxia equivalent to 3800m terrestrial altitude. The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m. Receives: Biological: Hypoxia |
| Sham hypoxia | Sham comparator | The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m. Receives: Biological: Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in affective responses
Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect
Measured: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Changes in state anxiety
Self-reported questionnaires to assess state anxiety
Measured: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Changes in subjective perception of stress
Self-reported questionnaires to assess subjective perception of stress
Measured: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Secondary outcomes (4)
Changes in anxious-depressive symptoms
Self-reported questionnaires to assess depression symptoms, anxiety symptoms, and subjectively perceived impairment due to physical and psychological symptoms
Measured: 10 days, including 3 measurements at baseline, day 1 and follow-up day 7
Changes in inflammatory parameters CRP
Venous blood samples to assess CRP (C-reactive protein)
Measured: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Changes in inflammatory parameters IL-6
Venous blood samples to assess IL-6 (interleukin 6)
Measured: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Changes in oxidative stress
Capillary blood samples from the fingertip collected with the Free Carpe Diem device by DIACRON International to measure total antioxidant capacity and the antioxidant potential of plasma
Measured: 6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start14 Apr 2023
- Primary completion15 Jul 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Model description
- A double-blind randomized controlled crossover trial with two groups of participants will be conducted. One group will be a group of psychiatric patients and the other group will be a group of healthy controls. The study will follow a crossover design with random allocation of condition order (i.e., normobaric hypoxia or sham hypoxia).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaet Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Innsbruck
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323864
- Sponsor's protocol ID
- 2022
- Acronym
- Psychoxie
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Going to Altitude With Anxious-depressive Symptoms - a Randomised Cross Over Trial in Individuals With Mental Disorders and Healthy Controls
- ClinicalTrials.gov ID
- NCT05323864
- Acronym / sponsor ID
- Psychoxie / 2022
- Conditions
- Hypoxia, Mental Disorder
- Keywords
- anxiety, depressive symptoms, high altitude
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universitaet InnsbruckUniversity, hospital or other
- Collaborators
- Medical University Innsbruck
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2022 (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.
Introduction: Currently, there is a lack of international guidelines or clinical recommendations for individuals with mental illnesses (i.e., bipolar disorder, posttraumatic stress disorder) going on high altitude sojourns. However, these guidelines would be important considering that mental illnesses are among the most common disorders worldwide and millions of people are hiking at high altitudes in the Alps, being granted easy access up to 3800m by cable cars. Before conceptualizing these guidelines, it seems necessary to study the physiological and psychological effects of ambient pressure changes leading to oxygen deficiency (hypoxia) in individuals with mental illnesses when being exposed to hypoxic conditions. The investigators hypothesize a shift towards negative affective responses and state anxiety as well as increased levels of neurotransmitter precursor amino acids (PHE/TYR and KYN/TRP) in individuals with mental illnesses when being exposed to hypoxic conditions.
Methods and Analysis: The investigators plan to perform a double-blind randomized controlled trial in a safe laboratory environment by using a normobaric hypoxic chamber. Participants suffering from depression and anxiety symptoms will be included as well as age and sex-matched healthy controls. They will attend a six-hour exposure equivalent to 3800m of altitude as well as a six-hour exposure to sham hypoxic conditions. Recruited participants will be screened by the Beck Anxiety and Depression Inventory, the Symptom Checklist (SCL-90) as well as an interview assessment. Affective responses in state anxiety will be assessed before, and during each hour of exposure by using the Feeling Scale (FS), Felt Arousal Scale (FAS), Positive and Negative Affect Schedule (PANAS), State-Anxiety Inventory (STAI) and subjective mental stress levels (Visual Analogue Scale; VAS). Physiological parameters will be assessed by venous blood sampling, pulse oximetry and oxidative stress level measurement before entering the chamber, after three and six hours of exposure. Additionally, symptoms of acute mountain sickness will be assessed by the Lake Louise Score before, after three and six hours of exposure. Follow-up measurements are planned one and seven days after the chamber visit, consisting of venous blood sampling, the Beck Anxiety and Depression Inventory.
A series of univariate analyses of covariance (ANCOVA) for repeated measures will be used to test the three-way (i.e. "group × condition × time") and two-way ("group × condition" and "group × time") interactions. Analyses will be adjusted for possible confounding, by adding age, sex, smoking, prior AMS, and medication status in the models as covariates.
Ethics and dissemination: Ethical approval has been obtained from the ethics committee of the Medical University of Innsbruck (1250/2021).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A double-blind randomized controlled crossover trial with two groups of participants will be conducted. One group will be a group of psychiatric patients and the other group will be a group of healthy controls. The study will follow a crossover design with random allocation of condition order (i.e., normobaric hypoxia or sham hypoxia).
| Arm | Type | Receives |
|---|---|---|
| Normobaric hypoxia | Experimental | Biological: HypoxiaNormobaric hypoxia equivalent to 3800m terrestrial altitude. The chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m. |
| Sham hypoxia | Sham comparator | Biological: HypoxiaThe chamber located on the campus of the University of Innsbruck's Department of Sport Science. The chamber dimension is 5 x 3m. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- sufficient command of the German language
- no psychotic or cognitive disorders
- patients suffering from anxious-depressive symptoms (meeting the cut off points of light-medium in the screening for anxiety and depression symptoms)
Key exclusion criteria (4 listed)
- pregnant or breastfeeding
- permanent residence above 1000m
- overnight stays at altitudes above 2500m in the previous month
- exposure to 2500m or higher two weeks prior to the six-hour hypoxic exposure
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 |
|---|---|---|
| HypoxiaParticipants will be randomly assigned to start with the normobaric hypoxia condition or the sham hypoxia condition. They will swap to the other condition during the second visit, which will be executed at least 14 days after the first visit. Each sojourn will last for six hours and participants will reside in the chamber individually. During the six-hour stay, participants will be allowed to move freely within the chamber. | Biological | Normobaric hypoxia, Sham hypoxia |
Primary outcome
Changes in affective responses
Time frame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Self-reported questionnaire to assess affective valence, perceived activation, positive and negative affect
Changes in state anxiety
Time frame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Self-reported questionnaires to assess state anxiety
Changes in subjective perception of stress
Time frame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention
Self-reported questionnaires to assess subjective perception of stress
4 secondary outcomes
Changes in anxious-depressive symptoms
Time frame: 10 days, including 3 measurements at baseline, day 1 and follow-up day 7
Changes in inflammatory parameters CRP
Time frame: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Changes in inflammatory parameters IL-6
Time frame: 8 days, including 4 measurements pre intervention, after 3 hours of intervention, at the end of intervention (6 hours), and at follow-up after 7 days
Changes in oxidative stress
Time frame: 6 hours, including 3 measurements, measuring pre intervention, after 3 hours of intervention, at the end of intervention (6 hours)
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 10 Dec 2025.
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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.
University of Innsbruck, Department of Sport Science
Innsbruck, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxia in people with Hypoxia and Mental Disorder, run by Universitaet Innsbruck at 1 site in Austria.
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 3 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: looking for participants now, as of the sponsor's last update on 10 Dec 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 Austria. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in affective responses (time frame: up to 6 hours, including 8 measurements, measuring before the start of intervention, every hour during the intervention, and after the end of intervention). 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 10 Dec 2025.