Clinical trial Recruiting at 1 site Interventional Ages 21 to 60

Effects of Sleep Loss and Alcohol on Brain and Performance in Healthy Adults

Official title: Neurobehavioral Changes Following Spaceflight Stressors

Run by University of Pennsylvania · NCT07293494 · Data updated 2026-11-12

This study tests how sleep deprivation and moderate alcohol use affect thinking and motor skills in healthy adults to understand risks that could relate to spaceflight.

Quick facts

Study typeInterventional
Ages21 Years to 60 Years
SexAll
Enrollment56 (estimated)
SponsorUniversity of Pennsylvania
Academic / other
Drugs / interventionsradiation
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedAugust 4, 2026
Main results expectedDecember 2029
Study endsDecember 2029
Registry record updatedNovember 5, 2026
Trial IDNCT07293494 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 25-60 without significant health or psychiatric conditions, with stable sleep schedules and alcohol safety suitable for controlled exposure.

Probably not a fit

Individuals with recent substance issues, contraindicating medical conditions, or inability to comply with study procedures may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a controlled lab setting, up to 56 healthy adults aged 25-60 will experience three conditions (sleep deprivation, alcohol administration to a BAC of 0.08, and a control) across six days in a fixed but varied order. Participants will complete cognitive and sensorimotor tasks and undergo one MRI and multiple blood draws per condition, timed to peak impairment. The study aims to map dose-response relationships between CNS stressors and performance, in collaboration with parallel animal studies, to inform spaceflight risk mitigation.

Why it matters

Potential benefit: If successful, the findings could help predict and reduce performance declines in extreme environments, including spaceflight.

How similar studies have gone: Prior work in controlled CNS stressor experiments has shown measurable performance decrements; this study extends to combined stressors and translational aims.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University of Pennsylvania Perelman School of Medicine
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.