Cognitive ImpairmentALTIBRAINNCT06121206
Effects of Altitude-like Cognition Training on Neuroplasticity and Cognitive Functions
A study testing Altitude-like hypoxia (12% O2), Normoxia (20% O2) and Cognitive training in people with Cognitive Impairment and Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate the effects of a three-week altitude-like cognition training intervention in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Bipolar Disorder, Depression
- What is being tested?
- Altitude-like hypoxia (12% O2), Normoxia (20% O2) and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 30 Jul 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-50 years
- No psychiatric history
- Fluency in Danish
- 18-65 years
- International Classification of Diseases (ICD)-10 diagnosis of Bipolar Disorder or depression confirmed with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
- Fluency in Danish
Show all 31Show fewer
- Partial or full remission (defined as a score of ≤14 on the Hamilton Depression Rating Scale 17-items (HDRS-17) and the Young Mania Rating Scale (YMRS)
- Objectively-verified cognitive impairment according to Screen for Cognitive Impairment in Psychiatry (SCIP) and/or self-reported cognitive impairment measured with Cognitive Complaints in Bipolar disorder Rating Assessment (COBRA). For SCIP, their performance must be ≥0.5 standard deviations (SD) below their demographically adjusted expected total SCIP score or on minimum 2 SCIP subtest scores. For COBRA, patients must report substantial cognitive impairment defined as a score ≥14.
- Common Exclusion Criteria:
- Schizophrenia or schizoaffective disorder
- Neurological disorder
- Alcohol or substance abuse
- History of serious head trauma
- Previous altitude sickness
- Heart disease
- Diabetes
- Renal failure
- Untreated/insufficiently treated hypertension
- Thromboses or thromboembolic events
- First-degree family with thromboembolic events before age 60
- Pregnancy
- Breastfeeding
- Smoking or use other nicotine products regularly
- BMI>30
- Electroconvulsive therapy (ECT) 3 months prior to participation
- Dyslexia
- Claustrophobia (MRI scans)
- Pacemaker and/or other MRI incompatible metal implants (MRI scans)
- Participation in experiments with radioactivity (>10 mSv) within the last year (PET scans)
- Significant occupational exposure to radioactivity (PET scans)
- Medication incompatible with study aims (e.g., SV2A binding agents; PET scans)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Neurocognition and Emotion in Affective Disorders (NEAD) Centre, University of Copenhagen and Psychiatric Centre Copenhagen, Frederiksberg hospital
Copenhagen, Capital Region of Copenhagen, 1353
About this study
Official title: Altitude-like Cognition Training to Target Brain Erythropoietin as a Novel Mechanism of Long-lasting Neuroplasticity and Cognitive Functions
The goal of this clinical trial is to investigate the effects of a three-week altitude-like cognition training intervention in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2). This multi-modal intervention consists of an adaptive cognitive training programme that participants complete while they're inside an altitude-training room with 12% O2, corresponding to 4400 meters altitude.
Across substudy 1 and 2, the investigators hypothesize that altitude-like cognition training has a beneficial effect on cognition after three-weeks treatment completion measured with a global cognition composite score (primary outcome measure). Further, the investigators hypothesize that hypoxia and cognition training will yield improved executive functioning after treatment completion and changes in brain activity during working memory in the dorsal prefrontal cortex 4 weeks after treatment completion (secondary outcome measures). In the patient study, the investigators further hypothesize that the intervention will have beneficial effects on daily-life cognition measured in virtual reality (VR) 4 weeks after treatment completion (secondary outcome measure in substudy 2). For exploratory purposes, the study will examine effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes).
The investigators will compare the combination of altitude-like hypoxia (12%) and cognitive training with (1) hypoxia with no training, (2) cognitive training under normal oxygen levels (normoxia; 20%), and (3) normoxia with no training in healthy individuals (substudy 1). For patients with mood disorders (substudy 2) the effects of altitude-like hypoxia (12%) and cognitive training are compared to treatment as usual (TAU).
Read the detailed description
ALTIBRAIN aims to test a novel model, linking altitude-like oxygen manipulations, endogenous erythropoietin (EPO) in the brain, neuroplasticity and cognition. Specifically, ALTIBRAIN will determine whether upregulation of endogenous brain EPO by altitude-like hypoxia cognition training is a fundamental mechanism of enduring neuroplasticity and long-lasting cognitive improvement in humans. This will be investigated in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2).
Substudy 1 involves four intervention groups: (1) altitude-like hypoxia (12%) combined with cognitive training, (2) hypoxia with no training, (3) cognitive training under normoxia (20%), and (4) normoxia with no training. Participants are randomised in blocks of four and undergo interventions in these groups for practical reasons. During the 3-weeks treatment, participants breathe 12% ambient oxygen (≈4400 meters altitude) or normal sea-level oxygen (20%) in a treatment room, 3.5 hours daily, six days per week. On iPads, they perform cognitive training or matched control games without cognitive benefits. Cognitive training is interleaved by short breaks, during which the participants can relax or walk on a treadmill inside the room. Participants undergo cognition assessments in weeks 1 (baseline), 4 and 8 and functional and structural MRI in weeks 1 and 8, when red blood cells are comparable between groups. A subgroup will also undergo PET scanning in week 4.
In substudy 2, patients are randomized to either (1) altitude-like hypoxia (12%) combined with cognitive training, 3.5 hours daily, five-six days per week for three weeks or (2) treatment as usual (TAU). After completed testing, patients in the TAU group undergo the 3-week active intervention, followed by an additional session of neurocognitive testing in the week after treatment completion. All remaining study procedures are identical to substudy 1.
The power calculation was based on the primary hypothesis that altitude-like hypoxia combined with cognitive training produces robust sustained cognitive improvement compared with normoxia and no training. To accommodate for up to a 15% drop-out, we will include 30 participants per group; i.e., 120 healthy individuals and 60 patients to obtain complete data for minimum 26 participants per group, i.e., 104 healthy individuals and 52 patients.
- Conditions
- Cognitive Impairment, Bipolar Disorder, Depression
- Being tested
- Altitude-like hypoxia (12% O2), Normoxia (20% O2), Cognitive training, Sham training
- Keywords
- Cognition, Neuroplasticity, Hypoxia, Cognitive training, Depression, Bipolar Disorder, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction, Bipolar Disorder, Depression, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altitude-like hypoxia (12% O2)Other
Fresh air with 12% O2, is blown into a sealed 20 m³ room by a 4kW air compressor with a safety-approved system developed by HöhenBalance, Austria. After participants enter the room, the O2 levels will be reduced from 16% to 12% (≈ 4,400 meters altitude) in a 30 minutes lead-in phase. The target O2 level of 12% will be maintained over three hours
Normoxia (20% O2)Other
Fresh air with 20% O2, is blown into a sealed 20 m³ room by a 4kW air compressor with a safety-approved system developed by HöhenBalance, Austria. The target O2 level of 20% will be maintained over 3.5 hours
Cognitive trainingBehavioural
The web-based cognitive training (Happy Neuron Pro) is grounded on principles of neuroplasticity-based learning by being intensive, neuroadaptive, engaging and rewarding. The active training involves parametric task adjustment by decreasing stimuli presentation time, increasing working memory load, decreasing time to respond, and increasing the number of non-target items (distractors).
Sham trainingBehavioural
Participants in the no training control condition receive computer games similar to Happy Neuron Pro but with low cognitive demand that produce no cognitive benefits. Specifically, this sham procedure involves the exact same stimuli as the active condition but with changes from trial to trial only in the appearance of the tasks.
| Study group | Role | What they receive |
|---|---|---|
| Altitude-like hypoxia (12%) combined with cognitive training | Experimental | Participants breathe 12% ambient oxygen in an altitude-training room, 3.5 hours daily, 5-6 days per week for 3 weeks. On iPads, they perform cognitive training, which is interleaved by short breaks. Receives: Other: Altitude-like hypoxia (12% O2); Behavioral: Cognitive training |
| Altitude-like hypoxia (12%) with no training | Active comparator | Participants breathe 12% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform matched control games without cognitive benefits, which is interleaved by short breaks. Receives: Other: Altitude-like hypoxia (12% O2); Behavioral: Sham training |
| Normoxia (20%) combined with cognitive training | Active comparator | Participants breathe 20% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform cognitive training, which is interleaved by short breaks. Receives: Other: Normoxia (20% O2); Behavioral: Cognitive training |
| Normoxia (20%) combined with no training | Sham comparator | Participants breathe 20% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform matched control games without cognitive benefits, which is interleaved by short breaks. Receives: Other: Normoxia (20% O2); Behavioral: Sham training |
| Treatment as usual | No intervention | Participants receive no additional care or intervention between baseline and end-of-treatment assessment points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive composite score
A cognitive composite based on an average of Z-transformed scores from the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter "D", WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) speed for correct responses from Cambridge Cognition (CANTAB). No score range. Higher scores mean a better outcome.
Measured: Baseline, week 4 (end of treatment. Primary outcome assessement time point), and week 8 (+end of treatment follow-up for patients in treatment as usual group)
Secondary outcomes (3)
"Mean choices to correct" in One Touch Stockings of Cambridge (OTS) from Cambridge Cognition (CANTAB)
Neuropsychological test assessing executive functions. No score range. Lower scores mean a better outcome.
Measured: Baseline, week 4 (end of treatment. Secondary outcome assessement time point), and week 8 (+end of treatment follow-up for patients in treatment as usual group)
Dorsal prefrontal cortex activity during spatial N-back
Functional magnetic resonance imaging (fMRI) measure of brain activity during a working memory task.
Measured: Baseline, week 8
ONLY IN PATIENTS (SUBSTUDY 2): Cognition Assessement in Virtual Reality (CAVIR) test: Composite score
Self-administered 360º immersive virtual reality test in a kitchen, where the participant's abilities to plan and prepare a meal are assessed. The test involves five subtasks probing verbal memory, executive functions, processing speed, working memory and sustained attention, which are summarized in a composite score. No score range. Higher scores mean a better outcome.
Measured: Baseline, week 8 (secondary outcome assessment time point) (+end of treatment follow-up for patients in treatment as usual group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Feb 2023
- Primary completion1 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Kamilla Woznica Miskowiak, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Kamilla W Miskowiak, DMSc, DPhil, Principal investigator, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121206
- Sponsor's protocol ID
- H-22028111
- Other IDs
- P-2022-354
- Acronym
- ALTIBRAIN
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen KHR, Ostergaard IP, Damgaard V, Schandorff JM, Macoveanu J, Pernet C, Julsgart HW, Johansen A, Brendstrup-Brix K, Kessing LV, Jorgensen MB, Ehrenreich H, Knudsen GM, Miskowiak K. Prefrontal and hippocampal microstructural gray matter following cognitive training under moderate hypoxia in mood disorders: a randomized controlled trial. Front Neurosci. 2026 Apr 8;20:1798024. doi: 10.3389/fnins.2026.1798024. eCollection 2026.
PubMed 42027683Miskowiak KW, Damgaard V, Schandorff JM, Macoveanu J, Knudsen GM, Johansen A, Plaven-Sigray P, Svarer C, Fussing CB, Cramer K, Jorgensen MB, Kessing LV, Ehrenreich H. Effects of cognitive training under hypoxia on cognitive proficiency and neuroplasticity in remitted patients with mood disorders and healthy individuals: ALTIBRAIN study protocol for a randomized controlled trial. Trials. 2024 Oct 3;25(1):648. doi: 10.1186/s13063-024-08463-5.
PubMed 39363230
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altitude-like Cognition Training to Target Brain Erythropoietin as a Novel Mechanism of Long-lasting Neuroplasticity and Cognitive Functions
- ClinicalTrials.gov ID
- NCT06121206
- Acronym / sponsor ID
- ALTIBRAIN / H-22028111
- Conditions
- Cognitive Impairment, Bipolar Disorder, Depression
- Keywords
- Cognition, Neuroplasticity, Hypoxia, Cognitive training, Depression, Bipolar Disorder, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- European Research Council, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 7 Nov 2023 (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.
The goal of this clinical trial is to investigate the effects of a three-week altitude-like cognition training intervention in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2). This multi-modal intervention consists of an adaptive cognitive training programme that participants complete while they're inside an altitude-training room with 12% O2, corresponding to 4400 meters altitude.
Across substudy 1 and 2, the investigators hypothesize that altitude-like cognition training has a beneficial effect on cognition after three-weeks treatment completion measured with a global cognition composite score (primary outcome measure). Further, the investigators hypothesize that hypoxia and cognition training will yield improved executive functioning after treatment completion and changes in brain activity during working memory in the dorsal prefrontal cortex 4 weeks after treatment completion (secondary outcome measures). In the patient study, the investigators further hypothesize that the intervention will have beneficial effects on daily-life cognition measured in virtual reality (VR) 4 weeks after treatment completion (secondary outcome measure in substudy 2). For exploratory purposes, the study will examine effects on additional measures of cognition, functioning and self-ratings scales (tertiary outcomes).
The investigators will compare the combination of altitude-like hypoxia (12%) and cognitive training with (1) hypoxia with no training, (2) cognitive training under normal oxygen levels (normoxia; 20%), and (3) normoxia with no training in healthy individuals (substudy 1). For patients with mood disorders (substudy 2) the effects of altitude-like hypoxia (12%) and cognitive training are compared to treatment as usual (TAU).
Detailed description
ALTIBRAIN aims to test a novel model, linking altitude-like oxygen manipulations, endogenous erythropoietin (EPO) in the brain, neuroplasticity and cognition. Specifically, ALTIBRAIN will determine whether upregulation of endogenous brain EPO by altitude-like hypoxia cognition training is a fundamental mechanism of enduring neuroplasticity and long-lasting cognitive improvement in humans. This will be investigated in healthy individuals (substudy 1) and symptomatically stable patients with mood disorders (depression or bipolar disorder; substudy 2).
Substudy 1 involves four intervention groups: (1) altitude-like hypoxia (12%) combined with cognitive training, (2) hypoxia with no training, (3) cognitive training under normoxia (20%), and (4) normoxia with no training. Participants are randomised in blocks of four and undergo interventions in these groups for practical reasons. During the 3-weeks treatment, participants breathe 12% ambient oxygen (≈4400 meters altitude) or normal sea-level oxygen (20%) in a treatment room, 3.5 hours daily, six days per week. On iPads, they perform cognitive training or matched control games without cognitive benefits. Cognitive training is interleaved by short breaks, during which the participants can relax or walk on a treadmill inside the room. Participants undergo cognition assessments in weeks 1 (baseline), 4 and 8 and functional and structural MRI in weeks 1 and 8, when red blood cells are comparable between groups. A subgroup will also undergo PET scanning in week 4.
In substudy 2, patients are randomized to either (1) altitude-like hypoxia (12%) combined with cognitive training, 3.5 hours daily, five-six days per week for three weeks or (2) treatment as usual (TAU). After completed testing, patients in the TAU group undergo the 3-week active intervention, followed by an additional session of neurocognitive testing in the week after treatment completion. All remaining study procedures are identical to substudy 1.
The power calculation was based on the primary hypothesis that altitude-like hypoxia combined with cognitive training produces robust sustained cognitive improvement compared with normoxia and no training. To accommodate for up to a 15% drop-out, we will include 30 participants per group; i.e., 120 healthy individuals and 60 patients to obtain complete data for minimum 26 participants per group, i.e., 104 healthy individuals and 52 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Altitude-like hypoxia (12%) combined with cognitive training | Experimental | Other: Altitude-like hypoxia (12% O2), Behavioral: Cognitive trainingParticipants breathe 12% ambient oxygen in an altitude-training room, 3.5 hours daily, 5-6 days per week for 3 weeks. On iPads, they perform cognitive training, which is interleaved by short breaks. |
| Altitude-like hypoxia (12%) with no training | Active comparator | Other: Altitude-like hypoxia (12% O2), Behavioral: Sham trainingParticipants breathe 12% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform matched control games without cognitive benefits, which is interleaved by short breaks. |
| Normoxia (20%) combined with cognitive training | Active comparator | Other: Normoxia (20% O2), Behavioral: Cognitive trainingParticipants breathe 20% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform cognitive training, which is interleaved by short breaks. |
| Normoxia (20%) combined with no training | Sham comparator | Other: Normoxia (20% O2), Behavioral: Sham trainingParticipants breathe 20% ambient oxygen in an altitude-training room, 3.5 hours daily, 6 days per week for 3 weeks. On iPads, they perform matched control games without cognitive benefits, which is interleaved by short breaks. |
| Treatment as usual | No intervention | –Participants receive no additional care or intervention between baseline and end-of-treatment assessment points. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 18-50 years
- No psychiatric history
- Fluency in Danish
- 18-65 years
- International Classification of Diseases (ICD)-10 diagnosis of Bipolar Disorder or depression confirmed with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Altitude-like hypoxia (12% O2)Fresh air with 12% O2, is blown into a sealed 20 m³ room by a 4kW air compressor with a safety-approved system developed by HöhenBalance, Austria. After participants enter the room, the O2 levels will be reduced from 16% to 12% (≈ 4,400 meters altitude) in a 30 minutes lead-in phase. The target O2 level of 12% will be maintained over three hours | Other | Altitude-like hypoxia (12%) combined with cognitive training, Altitude-like hypoxia (12%) with no training |
| Normoxia (20% O2)Fresh air with 20% O2, is blown into a sealed 20 m³ room by a 4kW air compressor with a safety-approved system developed by HöhenBalance, Austria. The target O2 level of 20% will be maintained over 3.5 hours | Other | Normoxia (20%) combined with cognitive training, Normoxia (20%) combined with no training |
| Cognitive trainingThe web-based cognitive training (Happy Neuron Pro) is grounded on principles of neuroplasticity-based learning by being intensive, neuroadaptive, engaging and rewarding. The active training involves parametric task adjustment by decreasing stimuli presentation time, increasing working memory load, decreasing time to respond, and increasing the number of non-target items (distractors). | Behavioural | Altitude-like hypoxia (12%) combined with cognitive training, Normoxia (20%) combined with cognitive training |
| Sham trainingParticipants in the no training control condition receive computer games similar to Happy Neuron Pro but with low cognitive demand that produce no cognitive benefits. Specifically, this sham procedure involves the exact same stimuli as the active condition but with changes from trial to trial only in the appearance of the tasks. | Behavioural | Altitude-like hypoxia (12%) with no training, Normoxia (20%) combined with no training |
Primary outcome
Cognitive composite score
Time frame: Baseline, week 4 (end of treatment. Primary outcome assessement time point), and week 8 (+end of treatment follow-up for patients in treatment as usual group)
A cognitive composite based on an average of Z-transformed scores from the Rey Auditory Verbal Learning Test (RAVLT), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding, verbal fluency with the letter "D", WAIS-III Letter-Number Sequencing, Trail Making Test B (TMT B) and Rapid Visual Information Processing (RVP) speed for correct responses from Cambridge Cognition (CANTAB). No score range. Higher scores mean a better outcome.
3 secondary outcomes
"Mean choices to correct" in One Touch Stockings of Cambridge (OTS) from Cambridge Cognition (CANTAB)
Time frame: Baseline, week 4 (end of treatment. Secondary outcome assessement time point), and week 8 (+end of treatment follow-up for patients in treatment as usual group)
Dorsal prefrontal cortex activity during spatial N-back
Time frame: Baseline, week 8
ONLY IN PATIENTS (SUBSTUDY 2): Cognition Assessement in Virtual Reality (CAVIR) test: Composite score
Time frame: Baseline, week 8 (secondary outcome assessment time point) (+end of treatment follow-up for patients in treatment as usual group)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 42027683Jensen KHR, Ostergaard IP, Damgaard V, Schandorff JM, Macoveanu J, Pernet C, Julsgart HW, Johansen A, Brendstrup-Brix K, Kessing LV, Jorgensen MB, Ehrenreich H, Knudsen GM, Miskowiak K. Prefrontal and hippocampal microstructural gray matter following cognitive training under moderate hypoxia in mood disorders: a randomized controlled trial. Front Neurosci. 2026 Apr 8;20:1798024. doi: 10.3389/fnins.2026.1798024. eCollection 2026.
- Derived from this study: PubMed 39363230Miskowiak KW, Damgaard V, Schandorff JM, Macoveanu J, Knudsen GM, Johansen A, Plaven-Sigray P, Svarer C, Fussing CB, Cramer K, Jorgensen MB, Kessing LV, Ehrenreich H. Effects of cognitive training under hypoxia on cognitive proficiency and neuroplasticity in remitted patients with mood disorders and healthy individuals: ALTIBRAIN study protocol for a randomized controlled trial. Trials. 2024 Oct 3;25(1):648. doi: 10.1186/s13063-024-08463-5.
- Individual participant dataSharing planned: No
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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.
Kamilla W Miskowiak, DMSc, DPhil principal investigator
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altitude-like hypoxia (12% O2), Normoxia (20% O2) and Cognitive training in people with Cognitive Impairment and Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 31 inclusion and 0 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: finished, as of the sponsor's last update on 26 Sep 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive composite score (time frame: Baseline, week 4 (end of treatment. Primary outcome assessement time point), and week 8 (+end of treatment follow-up for patients in treatment as usual group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121206, which also lists 2 linked publications.
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 26 Sep 2025.