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Study on the Effects of 100 Days of Isolation and Confinement on Human Health, Performance, and Well-being

Study on the Effects of 100 Days of Isolation and Confinement on Human Health, Performance, and Well-being - SOLIS100

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038466
Enrollment
6
Registered
2025-11-27
Start date
2026-04-06
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of Isolation and Confinement on Human Health, Performance, and Well-being

Interventions

Group 1: Phase 1: 2-day teambuilding training Phase 2: 14 days of technical training and baseline data collection (“days prior to launch” L-14 to L-1) at the :envihab Phase 3: 100 days of isolation

Sponsors

European Space Agency
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 55 Years

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

MeasureTime 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

MeasureTime 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

Public ContactAlexandra Noppe

DLR - Institut für Luft- und Raumfahrtmedizin

alexandra.noppe@dlr.de+49 2203 601 3746

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026