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DEEPTIME: Human Adaptation in Time Underground Isolation (DEEPTIME)

Primary Purpose

Physiological Stress, Cognitive Dysfunction, Sleep

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exploratory protocol
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physiological Stress focused on measuring Cognition, exploration, mission, endogenous biological clock, circadian rhythm, adaptation, temporal isolation, free-running, group influence, sleep, temporal anomie

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU CAEN

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

group 1

Arm Description

one cohort

Outcomes

Primary Outcome Measures

Time
- Evaluation of time perception perceived by subjects (minute and days) every 10 days up to 40 days
chronobiology
-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
Human Factors: ethological measurments with video 24/24, actimetric circadian rythms
- 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
Physiology
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.
Cognition, Emotion and personnality
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)

Secondary Outcome Measures

Full Information

First Posted
December 1, 2021
Last Updated
October 27, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT05603780
Brief Title
DEEPTIME: Human Adaptation in Time Underground Isolation
Acronym
DEEPTIME
Official Title
Cognitive, Emotional, Physiological, Chronobiological and Genetic Effects of a Time Underground Isolation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
September 11, 2021 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physiological Stress, Cognitive Dysfunction, Sleep
Keywords
Cognition, exploration, mission, endogenous biological clock, circadian rhythm, adaptation, temporal isolation, free-running, group influence, sleep, temporal anomie

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Follow-up of one group of healthy participant to 40days in a contraint underground environment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Other
Arm Description
one cohort
Intervention Type
Behavioral
Intervention Name(s)
exploratory protocol
Intervention Description
physiological and cognitive evaluations
Primary Outcome Measure Information:
Title
Time
Description
- Evaluation of time perception perceived by subjects (minute and days) every 10 days up to 40 days
Time Frame
every ten days up to 40 days
Title
chronobiology
Description
-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
Time Frame
every 5 days up to 40 days
Title
Human Factors: ethological measurments with video 24/24, actimetric circadian rythms
Description
- 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
Time Frame
all along the cavern experiment for 40 days
Title
Physiology
Description
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.
Time Frame
every ten days up to 40 days
Title
Cognition, Emotion and personnality
Description
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)
Time Frame
every ten to 15 days up to 40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
stephane besnard, MD
Organizational Affiliation
CaenHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU CAEN
City
Caen
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.deeptime.fr
Description
website of the scientific expedition

Learn more about this trial

DEEPTIME: Human Adaptation in Time Underground Isolation

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