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NCT07293494
Neurobehavioral Changes Following Spaceflight Stressors
Conditions: Stressor, Individual, Alcohol Impairment, Sleep Deprivation, Impairment, Cognitive
Sex: All
Ages: 21 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 56
Sponsor: University of Pennsylvania
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age between 21-60 years.
* Free of psychological, psychiatric or physical conditions that preclude participation.
* BMI between 18.5 and 35.
* Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
* Self-reported sleep duration of 6-8.5 h per night (verified by daily logs).
* Ability to read/write English.
* Able to stand unassisted for up to 10 minutes at a time and able to lift arms above head.
Exclusion Criteria:
* Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
* 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).
* Alcohol-naive based on self-report (AUDIT-C Q1 score of 0).
* 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).
* Cultural or personal beliefs that preclude alcohol consumption.
* Body Mass Index ≤18.5 or ≥ 35.
* Current smoker/tobacco user or using nicotine replacement therapy. Those that have been nicotine-free for ≥ 30 days may be included.
* Excessive caffeine consumption (\> 650mg/day combining all caffeinated drinks regularly consumed during the day).
* 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/or lifestyles that preclude alcohol consumption and/or sleep disruption.
* 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).
* Cardiovascular, gastrointestinal, or musculoskeletal problems, or other major conditions such as organ failure, cancer or patients requiring oxygen.
* Prior history or diagnosis of any sleep disorder including Obstructive Sleep Apnea (AHI ≥15 events/hour) - 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).
* 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).
* 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/objects which are non-removable; pregnancy (or its possibility); previous brain and/or heart surgery.
* History of severe motion sickness, based on self-report or driving simulator response.
* 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.
* Individuals who self-report severe contact dermatitis or allergy to bandages, silicone, nickel or silver.
* Currently working night, swing, split or rotating shift.
* Planned travel across more than one time zone within 7 days of the scheduled study start date.
* Habitual daytime napping.
Source: ClinicalTrials.gov (NCT07293494). StuddyBuddy aggregates publicly available trial information.