NCT06121206Completed
Effects of Altitude-like Cognition Training on Neuroplasticity and Cognitive Functions
Altitude-like Cognition Training to Target Brain Erythropoietin as a Novel Mechanism of Long-lasting Neuroplasticity and Cognitive Functions
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 190 (actual)
- First submitted
- 31 Oct 2023
- Start date
- 1 Feb 2023
- Primary completion date
- 1 Jul 2025
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT06121206
What you commit to
- Study type: Interventional
- Participants enrolled: 190
- From 1 Feb 2023 to the primary completion date, 1 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- 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)
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurocognition and Emotion in Affective Disorders (NEAD) Centre, University of Copenhagen and Psychiatric Centre Copenhagen, Frederiksberg hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.