- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05603780
DEEPTIME: Human Adaptation in Time Underground Isolation (DEEPTIME)
Cognitive, Emotional, Physiological, Chronobiological and Genetic Effects of a Time Underground Isolation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This exceptional period has shown a significant desynchronization and loss of notion of time in a large number of people as well as important questions about human abilities to live in confined conditions. It is partly for this reason, but also to answer more fundamental questions on the perception of time that the extraordinary research expedition Deep Time was conceived: 40 days underground to know the links of our brain to time and synchronization within a group. A fundamental need for our future. This scientific expedition will take place entirely in France to ensure the feasibility and safety of the subjects and experimenters, under the direction of Christian Clot and the Institute of Human Adaptation, placed under the high patronage of the Ministry of Education, Research and Innovation.
The project addresses the fundamental question of human adaptation to the physical environment and the crucial role of the brain's neuroplasticity properties.
The present "Deep-Time" protocol naturally echoes the "out-of-time" isolation experiments conducted by the speleologist Michel Siffre starting in 1962 and its various components in the years that followed.
These "out of time" experiments led to certain conclusions. As curious as it may seem, in the absence of the time givers (synchronizers or Zeitgebers in German) that are the social rhythms and the day-night alternations, the spontaneous rhythm would settle on a rhythm of about 25 hours.
However, these experiments remained limited to isolated individuals, in conditions of spatial unity (no displacement outside of the work camps), leaving a whole field of research and questioning that the year 2021 has strongly emphasized.
The objectives of this scientific expedition are: a/ Evaluation of temporal cognitive perception and collective synchronization in a temporally anomalous universe (underground environment), b/ Influence of group living on the endogenous circadian rhythmicity of the central biological clock and peripheral clocks in a "free-running" situation (absence of light/natural darkness), c/Evaluation of cognitive and physiological performance in response to exposure to an extreme environment in a natural underground cavity (cave) without access to a time indicator for 40 days, d/Correlation of cognitive, behavioral, psychological, social, neurophysiological and physiological parameters, e/ Determination of adaptation or maladaptation criteria (biological, genetic, physiological, neurophysiological, psychological and cognitive) in an isolation environment (underground) f/ Study of the evolution of collective organization, decision making and leadership in an extreme isolation and management situation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Caen, France
- CHU Caen
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Strictly right-handed Good health without any medical and psychiatric diseases No contraindications to MRI French or European nationality Not to be included in another biomedical protocol
Exclusion Criteria:
Being pregnant Minor, under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: group 1
one cohort
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physiological and cognitive evaluations
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: every ten days up to 40 days
|
- Evaluation of time perception perceived by subjects (minute and days) every 10 days up to 40 days
|
every ten days up to 40 days
|
|
chronobiology
Time Frame: every 5 days up to 40 days
|
-Influence of group living on the endogenous circadian rhythmicity of the central biological clock and peripheral clocks in a "free-running" situation (absence of light / natural darkness): measurments of body core temperature, cortisol and melatonine salivary concentration circadian rythms
|
every 5 days up to 40 days
|
|
Human Factors: ethological measurments with video 24/24, actimetric circadian rythms
Time Frame: all along the cavern experiment for 40 days
|
- Evaluation of the capacity of a group to find a synchronicity and a way of life in a new context, extreme in its environmental and temporal dimensions and out of the initial competences of each group member.
Measurments of social interaction, comparison of actimetric circadien rythm
|
all along the cavern experiment for 40 days
|
|
Physiology
Time Frame: every ten days up to 40 days
|
Physiological parameters (HRV, lean and fat mass by impedancemtry, weight in kg, core body temperature) in response to exposure to an extreme environment in a natural underground cave for 40 days.
|
every ten days up to 40 days
|
|
Cognition, Emotion and personnality
Time Frame: every ten to 15 days up to 40 days
|
Evaluation of cognitive (taking decision, emotion, spatial cognition) through differents paradigms displayed on screen of Headset in 2D and 3D virtual reality. Mesurements of time reaction, risk score, number of strategy or procedural errors, time to achieve the tasks. Questionnaires (STAI, POMS, big five inventory, IP9) |
every ten to 15 days up to 40 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: stephane besnard, MD, CaenHU
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A00747-37
- 27/21_2 (Other Identifier: Ethical Committee)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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