NCT05603780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
Last Updated

April 2, 2026

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

December 1, 2021

Last Update Submit

March 30, 2026

Conditions

Keywords

Cognitionexplorationmissionendogenous biological clockcircadian rhythmadaptationtemporal isolationfree-runninggroup influencesleeptemporal anomie

Outcome Measures

Primary Outcomes (5)

  • Time

    \- 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

    -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

    \- 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

    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

    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

Study Arms (1)

group 1

OTHER

one cohort

Behavioral: exploratory protocol

Interventions

physiological and cognitive evaluations

group 1

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Being pregnant Minor, under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU CAEN

Caen, France

Location

Related Publications (1)

  • Arbeille P, Zuj KA, Besnard S, Mauvieux B, Hingrand C, Delaunay PL, Hughson RL, Clot C. Ultrasound assessments of organs and blood vessels before and after 40 days isolation in a cavern (deep time experiment 2021). Front Physiol. 2023 Apr 24;14:1174565. doi: 10.3389/fphys.2023.1174565. eCollection 2023.

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • stephane besnard, MD

    CaenHU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Follow-up of one group of healthy participant to 40days in a contraint underground environment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2021

First Posted

November 3, 2022

Study Start

March 11, 2021

Primary Completion

September 11, 2021

Study Completion

March 11, 2022

Last Updated

April 2, 2026

Record last verified: 2022-08

Locations