[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stressor-individual\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stressor-individual":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100615506","neurobehavioral-changes-following-spaceflight-stressors-100615506",false,"NCT07293494","Neurobehavioral Changes Following Spaceflight Stressors","NeuroSTAR","Inclusion Criteria:\n\n* Age between 25-60 years.\n* Free of psychological, psychiatric or physical conditions that preclude participation.\n* BMI between 18.5 and 35.\n* Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.\n* Self-reported sleep duration of 6-8.5 h per night (verified by daily logs).\n* Ability to read\u002Fwrite English.\n* Able to stand unassisted for up to 10 minutes at a time and able to lift arms above head.\n\nExclusion Criteria:\n\n* Alcohol or drug abuse in the past year based upon history and urine toxicology screen.\n* Potential alcohol abuse or heavy drinking in the past year, based on self-report (AUDIT-C Q2 score above 1 or Q3 score above 2).\n* Alcohol-naive based on self-report (AUDIT-C Q1 score of 0).\n* Allergies, conditions or circumstances that preclude alcohol consumption, including use of medication or supplements (prescription or over the counter) that could interfere with study participation or make it hazardous for a subject to partake (e.g., anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified), or for which alcohol consumption should be limited or avoided (e.g. items identified on NIAAA's 'Harmful Interactions' list).\n* Cultural or personal beliefs that preclude alcohol consumption.\n* Body Mass Index ≤18.5 or ≥ 35.\n* Current smoker\u002Ftobacco user or using nicotine replacement therapy. Those that have been nicotine-free for ≥ 30 days may be included.\n* Excessive caffeine consumption (\\> 650mg\u002Fday combining all caffeinated drinks regularly consumed during the day).\n* Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries; or self-reported history of neurological, psychiatric, or other medical condition that precludes participation, such as nervous system disorders, dementia, chronic migraines, or epilepsy; panic, bipolar or schizoaffective disorder; sleep disorders including insomnia, narcolepsy and obstructive sleep apnea; liver, kidney or heart disease, hypertension; infectious diseases; diabetes; or any other conditions for which medical monitoring is advised and which may require medications and\u002For lifestyles that preclude alcohol consumption and\u002For sleep disruption.\n* Current depression as determined on the Beck Depression Inventory (Beck, 1996), by either a total score of 19 or higher or a response greater than 0 on Q9 (suicidality).\n* Cardiovascular, gastrointestinal, or musculoskeletal problems, or other major conditions such as organ failure, cancer or patients requiring oxygen.\n* Prior history or diagnosis of any sleep disorder including Obstructive Sleep Apnea (AHI ≥15 events\u002Fhour) - from ambulatory or in lab polysomnography; Restless legs syndrome or periodic limb movement disorder; Insomnia; Parasomnia; High Risk of OSA based on STOP-BANG Questionnaire (\"yes\" on at least 4 of 8 questions); High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire; High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher).\n* Current use or use within the past month of a prescription or over-the-counter sleep medication or stimulant (based on self-report or review with a study clinician).\n* History of potential MRI contraindications, including: tinnitus; sensorineural hearing loss \\> 30 dB; pace maker or internal defibrillator; metallic implants (e.g. orthopedic plates after bone fractures, joint replacements, surgical staples or clips, artificial heart valves, stents, cava filters); metallic splinters (e.g. after an accident or due to war injury); non-removable dental brace; Tattoo (some tattoo inks contain metallic particles); permanent make-up; non-MRI compatible intrauterine contraceptive device; cochlear implant (implanted hearing device); medication pump; acupuncture needle; other foreign bodies\u002Fobjects which are non-removable; pregnancy (or its possibility); previous brain and\u002For heart surgery.\n* History of severe motion sickness, based on self-report or driving simulator response.\n* Pregnant or currently breast feeding. People that menstruate will have a pregnancy test performed via urine sample during screening, as those that are currently pregnant are unable to participate in the study.\n* Individuals who self-report severe contact dermatitis or allergy to bandages, silicone, nickel or silver.\n* Currently working night, swing, split or rotating shift.\n* Planned travel across more than one time zone within 7 days of the scheduled study start date.\n* Habitual daytime napping.",true,"ALL","25 Years","60 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to investigate the impairing effects of known central nervous system (CNS) stressors in a controlled environment in order to predict and mitigate analogous risks in spaceflight. Up to 56 healthy individuals aged 25-60 will spend approx. 110 hours in a laboratory, where they will be exposed to 27 hours of sleep deprivation and will consume alcohol to reach a BAC of 0.08 on a separate day. They will perform cognitive and sensorimotor tasks and undergo MRIs and blood draws.",[28,29,30,31],"Stressor, Individual","Alcohol Impairment","Sleep Deprivation","Impairment, Cognitive","NOT_YET_RECRUITING","2025-12-19",{"date":35,"type":36},"2025-12-29","ACTUAL",{"date":38,"type":22},"2026-06",{"date":40,"type":22},"2029-12",{"name":42,"class":43},"University of Pennsylvania","OTHER"]