Sleep Clinical Trial
— DEEPTIMEOfficial title:
Cognitive, Emotional, Physiological, Chronobiological and Genetic Effects of a Time Underground Isolation
Verified date | August 2022 |
Source | University Hospital, Caen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 11, 2022 |
Est. primary completion date | September 11, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU CAEN | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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