[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659012":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":40,"armGroups":36,"interventions":41,"overallOfficials":36,"centralContacts":45,"locations":36,"responsibleParty":55,"collaborators":57,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":36,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":36,"briefSummary":79,"conditions":80,"keywords":36,"overallStatus":83,"whyStopped":36,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":36},{"fullName":5,"class":6},"Vrije Universiteit Brussel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":36},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in experiential C-tactile (CT) sensitivity assessed by pleasantness and intensity ratings on a Visual Analog Scale ranging from -10 to +10 using the Manual Tactile Stimulator.","Experiential CT sensitivity will be assessed using standardized stroking touch, delivered with a mechanic Manual Tactile Stimulator tool to the forearm and palm at three velocities (0.3, 3, and 30 cm\u002Fs), using smooth and ribbed probe surfaces. Participants rate perceived pleasantness and intensity on a Visual Analog Scale ranging from -10 to +10. Changes in VAS scores across repeated assessments will be used to characterize experiential CT sensitivity over time.","Baseline (approximately 2-3 months before departure); Month 1, Month 4, Month 7, Month 10, and Month 12 during the Antarctic winter-over; 6 months post-mission; and 2 years post-mission.",{"measure":14,"description":15,"timeFrame":12},"Change in vicarious C-tactile (CT) sensitivity assessed by pleasantness and intensity ratings on a Visual Analog Scale ranging from -10 to +10 using the Vicarious Touch Task","Vicarious CT sensitivity will be assessed using standardized 6-second videos depicting interpersonal touch at different body locations and velocities. Participants rate the perceived pleasantness and intensity of the observed touch on a Visual Analog Scale ranging from -10 to +10. Changes in ratings across repeated assessments will be used to characterize vicarious CT sensitivity over time.",[17,20,24,27,30,33],{"measure":18,"description":19,"timeFrame":12},"Change in behavioral C-tactile (CT) sensitivity assessed by interpersonal space boundary using the Footstep Task with response time in milliseconds (ms).","Interpersonal space boundary will be assessed using an auditory stop-distance paradigm. Participants listen to approaching footsteps and press a key when the approaching person makes them feel uncomfortable. The outcome measure is the response time in milliseconds (ms) from stimulus onset to the stop response. Changes in response time across repeated assessments will be used as an indirect behavioral measure associated with CT sensitivity.",{"measure":21,"description":22,"timeFrame":23},"Change in neurobiophysiological C-tactile (CT) sensitivity assessed by salivary cortisol concentration (µg\u002FL) measured by saliva sampling and analyses","Salivary cortisol concentration concentration will be measured as a neuroendocrine marker of HPA-axis stress regulation associated with C-tactile (CT)-mediated touch. Saliva samples are collected on one combined sampling evening and morning per month. One sample is collected before bedtime and three samples are collected in the following morning: immediately after awakening, 30 minutes after awakening, and 60 minutes after awakening. Cortisol concentrations (µg\u002FL) and the cortisol awakening response (CAR) will be evaluated across repeated assessments over time.","Baseline (approximately 2-3 months before departure); monthly during the Antarctic winter-over; 6 months post-mission; and 2 years post-mission.",{"measure":25,"description":26,"timeFrame":12},"Change in neurobiophysiological C-tactile (CT) sensitivity assessed by plasma oxytocin concentration (pg\u002Fml) measured by blood sampling and analyses","Plasma oxytocin concentration will be measured from blood samples as a neuroendocrine marker associated with affiliative social touch and the rewarding neurobiology of C-tactile (CT)-mediated touch. Changes in plasma oxytocin concentration (pg\u002Fml) will be evaluated across repeated assessments over time.",{"measure":28,"description":29,"timeFrame":12},"Change in psychosocial and behavioral characteristics associated with C-tactile (CT) sensitivity assessed using standardized questionnaires with total and\u002For subscale questionnaire scores.","Psychosocial and behavioral characteristics will be assessed using the Touch Experiences and Attitudes Questionnaire - short version (TEAQ-s), Brief COPE, UCLA Loneliness Scale, Experiences in Close Relationships - Short Form (ECR-S), and State-Trait Anxiety Inventory (STAI). These questionnaires assess social touch experiences and attitudes, coping strategies, loneliness and social isolation, attachment anxiety and avoidance, and state\u002Ftrait anxiety, respectively. The outcome measures are the total and\u002For subscale questionnaire scores, calculated according to the scoring procedures of each instrument. Changes in these scores will be assessed across repeated measurements over time.",{"measure":31,"description":32,"timeFrame":23},"Change in behavioral and psychosocial adaptation associated with C-tactile (CT) sensitivity assessed using the 15-item ICE-Psychosocial Monitoring Scale with scores on a Visual Analog Scale (VAS-score 0-10).","Psychosocial adaptation during isolation and confinement will be assessed using the 15-item VAS-based ICE-Psychosocial Monitoring Scale. The scale assesses physical touch deprivation\u002Fcontact need, social contact and interpersonal connection, situational\u002Ftemporal loneliness, attachment and separation distress, and somatic self-soothing\u002Fphysical regulation. Changes in VAS-based scores will be assessed across repeated measurements over time.",{"measure":34,"description":35,"timeFrame":12},"Change in tactile sensory performance associated with C-tactile (CT) sensitivity measured with the Brain Gauge Tactile Reaction Time Test (TRTT) using reaction-time and discrimination outcomes.","Tactile sensory performance will be assessed using the Brain Gauge TRTT, a mouse-like device that delivers gentle tactile vibrations to the fingertips. The test battery includes simple reaction time, amplitude discrimination, temporal order judgment, and duration discrimination. Time-related outcomes will be expressed in milliseconds (ms). Changes in reaction-time and discrimination measures will be assessed across repeated measurements over time.",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","PROSPECTIVE","Winter-over Crew members in Concordia Station in Antarctica",[42],{"type":6,"name":43,"description":44,"armGroupLabels":36,"otherNames":36},"No Intervention: Observational Cohort","TACTICE is considered an observational study because the exposure of interest(i.e., long-term isolation and confinement during an Antarctic winter-over at Concordia Station) is not assigned by the study investigators. Participants are winter-over crew members who will stay at Concordia independently of their participation in TACTICE. The study follows this predefined cohort prospectively and repeatedly over time to observe changes in CT sensitivity, stress-related biological markers, behaviour, attitudes and interpersonal functioning. The protocol therefore describes TACTICE as a \"longitudinal study with a naturalistic design. The standardized touch stimulation, computer-based tasks, questionnaires, saliva sampling and blood sampling are used as study assessments to measure outcomes over time and not as therapeutic or diagnostic interventions.",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":36,"email":50},"Martine Van Puyvelde, Professor","CONTACT","0032 495 239 543","Martine.Van.Puyvelde@vub.be",{"name":52,"role":48,"phone":53,"phoneExt":36,"email":54},"Susannah Walker, Professor","+44 1519046309","S.C.Walker@ljmu.ac.uk",{"type":56,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[58,61,63],{"name":59,"class":60},"Belgium: Belgian Federal Science Policy Office (BELSPO)","UNKNOWN",{"name":62,"class":6},"European Space Agency",{"name":64,"class":6},"Institut Polaire Français Paul-Emile Victor (IPEV)","100659012","the-impact-of-long-term-isolation-in-antarctica-on-social-touch-and-its-underlying-biological-mechanisms-in-winter-over-crew-members-assessed-during-their-stay-using-standardized-touch-stimulation-computer-based-touch-sensitivity-tests-questionnaires-and-biological-markers-100659012",false,"NCT07858240","The Impact of Long-term Isolation in Antarctica on Social Touch and Its Underlying Biological Mechanisms in Winter-over Crew Members, Assessed During Their Stay Using Standardized Touch Stimulation, Computer-based Touch Sensitivity Tests, Questionnaires and Biological Markers.","Touching the Void: An Investigation Into the Role of a Population of Gentle Touch-Sensitive C-Tactile Afferents in Social Isolation and Somatosensory Deprivation During a Long-Duration Antarctic Stay.","TACTICE","Inclusion Criteria:\n\n* Member of the Concordia Station winter-over crew for the 2027 or 2028 Antarctic winter-over season and willing to participate in the study.\n\nExclusion Criteria:\n\n* No study-specific exclusion criteria.","ALL","18 Years",{"count":76,"type":77},28,"ESTIMATED","OBSERVATIONAL","TACTICE investigates how long-term isolation and reduced social touch during an Antarctic winter-over affect the way people perceive and respond to touch. The study will follow winter-over crew members at Concordia Station in Antarctica during the 2027 and 2028 seasons.\n\nThe study focuses on so-called C-tactile (CT) sensitivity. CT afferents are specialized nerve fibers in the skin that are known to be involved in the pleasant and regulatory effects of social touch. They may also play a role in how prolonged social isolation affects people during a long-term mission in an isolated, confined, and extreme (ICE) environment.\n\nParticipants will be assessed repeatedly before, during and after their stay. CT sensitivity will be measured using standardized touch stimulation and computer-based tasks involving touch-related stimuli. Participants will also complete questionnaires on social touch, loneliness, stress, relationships and coping. Saliva and blood samples will be collected to measure biological markers related to stress regulation and social processes, including cortisol and oxytocin.\n\nThe main hypothesis is that prolonged isolation and reduced opportunities for social touch change CT sensitivity and reduce an important source of stress regulation. These changes are expected to become more pronounced with time spent at the station and to be related to changes in stress responses, behaviour, attitudes and interpersonal functioning. The study aims to improve understanding of how people adapt to prolonged isolation and confinement and may help inform the planning of future long-duration missions in remote and extreme environments, including space missions.",[81,82],"Social Isolation","Isolated Confined and Extreme Conditions","NOT_YET_RECRUITING","2026-09-28",{"date":86,"type":87},"2026-10-05","ACTUAL",{"date":89,"type":77},"2026-10",{"date":91,"type":77},"2031-02",{"name":5,"class":6}]