Brain Changes in Response to Long-Duration Isolation and Confinement (NCT04532866) | Clinical Trial Compass
UnknownNot Applicable
Brain Changes in Response to Long-Duration Isolation and Confinement
Russia16 participantsStarted 2021-09-14
Plain-language summary
This study investigates the time course and magnitude of eight months of isolation and confinement in a spaceflight analog facility on brain changes and cognitive performance. The study also assesses the feasibility of an immersive and interactive virtual environment (VE) to enhance positive affect and mental well-being during prolonged isolation and confinement.
Who can participate
Age range
28 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Candidates who are professionals in the aerospace industry or related fields are eligible at a lower age limit of 28
* Height not to exceed 180 cm.
* Willing to be confined and isolated for up to 8 months.
* English and Russian verbal and written proficiency not lower than intermediate
* Absence of chronic disease or psychological deviations
Exclusion Criteria:
* Everybody who does not meet listed above requirements
* Past mental, cardiovascular, musculoskeletal and/or neurovestibular disorders or diseases
* Pronounced orthostatic intolerance or vestibular balance disorders (kinetosis)
* Abuses of drugs, medication or alcohol
* Claustrophobia
* Malnutrition up to 6 months before the start of the study
* Intake of anabolic steroids up to 6 months before study initiation
* Metal implants or other osteosynthesis materials
* Bisphosphonate therapy
* Taking medication that could influence the results of the examination.
* Taking hormonal contraceptives in the last 6 months before the start of the study
* Menstrual disorders
* Delivery up to 6 months before the start of studies
* clinically manifest abnormalities in the resting ECG that preclude participation in the study
* Hypertension (\> 130/85 mmHg)
* Increased risk of thrombosis
* Increased risk of stroke
* Infection with HIV or HBV
* HIV, hepatitis A, B, or tuberculosis infection
* clinically manifest changes in the differential blood count
* Clinically manifest changes according to the Comprehensive …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in brain structure
Timeframe: pre-intervention, immediately after the intervention, up to 30 days after study completion
2
Change in brain function
Timeframe: pre-intervention, immediately after the intervention, up to 30 days after study completion
3
Change in cognitive performance
Timeframe: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
4
Change in biochemical parameters
Timeframe: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion
5
Change in stress response
Timeframe: pre-intervention, monthly during the intervention, immediately after the intervention, up to 30 days after study completion