Neurobehavioral Changes Following Spaceflight Stressors

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07293494
Status
Recruiting
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Conditions

  • Alcohol Impairment
  • Impairment, Cognitive
  • Sleep Deprivation
  • Stressor, Individual

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Alcohol Administration — OTHER
    For the alcohol administration condition (ALC), subjects will consume alcohol within a window of approximately fifteen minutes in the morning in order to induce a blood alcohol content (BAC) level of 0.08%, in the form of 80-proof vodka mixed with fruit juice or clear, noncaffeinated soda at a 1:3 ratio. The specific dosage is determined by the Widmark formula, factoring in each individual's body weight and sex. BAC will be measured by a NHTSA-approved evidential breath testing (EBT) device, which measures breath alcohol content (BrAC, in grams per 210 liters of breath) and converts it to BAC (in g/100ml or g/dl). BAC will be measured before and after every task until subjects go to bed at 11 PM, at which point their BAC is expected to be at or close to 0.00%. Subjects will undergo an MRI (shortly after alcohol consumption at what is anticipated to be their highest level of intoxication to capture the impairing effects) and two blood draws (in the morning and afternoon).
  • Sleep Deprivation — BEHAVIORAL
    For the sleep deprivation condition (SD1\&2), subjects will remain awake for 27 hours from 8 AM until 11 AM the following morning (SD1). They will perform testing at regular intervals throughout the day and overnight, and they have two blood draws during the extended wake period. Subjects will undergo an MRI after approximately 25 hours of wakefulness, followed by a three-hour nap opportunity from 11 AM until 2 PM. They will then remain awake from 2 PM until 11 PM for testing and meals before returning to the standard sleep period of 11 PM to 8 AM (SD2). Caffeine will not be available to subjects during this period nor will it be available at any other time during the study.
  • Control — OTHER
    During the control condition (CTRL), subjects will have no stressor intervention. They will not consume alcohol and they will sleep during the standard period of 11 PM to 8 AM. They will perform testing at regular intervals throughout the day. They will undergo an MRI in the morning, and have two blood draws (in the morning and afternoon).

Study Details

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.

Key Dates

First listed
Dec 19, 2025
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group A: CTRL - ALC - SD1&2
    Group A will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Control (CTRL); Alcohol Administration (ALC); Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2).
  • Experimental: Group B: ALC - CTRL - SD1&2
    Group B will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Alcohol Administration (ALC); Control (CTRL); Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2).
  • Experimental: Group C: SD1&2 - CTRL - ALC
    Group C will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2); Alcohol Administration (ALC); Control (CTRL).
  • Experimental: Group D: CTRL - SD1&2 - ALC
    Group D will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Control (CTRL); Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2); Alcohol Administration (ALC).
  • Experimental: Group E: ALC - SD1&2 - CTRL
    Group E will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Alcohol Administration (ALC); Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2); Control (CTRL).
  • Experimental: Group F: SD1&2 - ALC - CTRL
    Group F will experience the interventions in the following order, following an adaptation night sleep from 11 PM to 8 AM: Sleep Deprivation for 27 hours (SD1) with Sleep Recovery (SD2); Alcohol Administration (ALC); Control (CTRL).

Primary Outcome Measure

Psychomotor Vigilance Task (PVT) lapses [ Time Frame: From Study Day 2 through Study Day 6 (to include each of the three conditions: ALC, CTRL, SD1&2). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Perelman School of MedicinePhiladelphiaPennsylvania19104
Sierra Park-Chavar
[email protected]
2155735855
Mathias Basner, MD, PhD, MScEpi
[email protected]
215-573-5866
Mathias Basner, MD, PhD, MScEpi (PRINCIPAL_INVESTIGATOR)

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