Effects of Isolation and Confinement on Human Health, Performance, and Well-being
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? Physically healthy test subjects (successful completion of the medical screening) ? Body mass index 18.5 to 30 kg/m2 ? Applicants must be willing to provide a complete family and personal (medical) history, including obtaining medical history, including obtaining further information if deemed necessary. ? Applicants must be able to speak and read sufficient English (level B2), as English is the language of the assignment ? Passed psychiatric/psychological assessment (confirmation that behaviour is suitable for use in isolation) ? Passed expert opinion on nutritional status ? Proof of health insurance ? Signed declaration of consent ? Bachelor's degree ? Good physical condition and fitness
Exclusion criteria
Exclusion criteria: ? Any acute or chronic illness that prevents safe participation in the project ? Severe allergic reactions to allergens to which the candidates may be exposed during the project to during the project (e.g. food allergens such as nuts or wheat, medications such as painkillers, environmental allergens such as latex) ? Claustrophobia ? Smoker within six months before the start of the mission ? Abuse of drugs, medication or alcohol ? Ongoing criminal proceedings ? Persons who are currently serving a sentence ? Female persons: Pregnancy, one year after pregnancy, breastfeeding women ? Tuberculosis, hepatitis, HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study is designed as a feasibility and high-validity study rather than a hypothesis driven clinical trial. It represents a 100-day isolation study, conducted without any countermeasures or interventions intended to alleviate or modify the effects of isolation. The primary objective is to demonstrate that the isolation can be carried out successfully and safely over the entire study duration, thereby establishing a reliable basis for future research. For this reason, no primary endpoints are defined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Success will be evaluated through the following measures: - Technical and facility performance data - Effectiveness of communication protocols between mission control and the isolated crew - Adherence to participant tasks outlined in the daily schedule - Participant feedback through interviews and questionnaires - Data quality and completeness - Implementation and monitoring of medical surveillance procedures - Execution and adherence to nutrition plans and dietary monitoring - Monitoring and implementation of exercise protocols and physical activity schedules. In addition to these endpoints which will indicate overall study integrity and mission fidelity, the selected science teams defined individual endpoints that address their scientific questions. | — |
Countries
Germany
Contacts
DLR - Institut für Luft- und Raumfahrtmedizin