Recruiting

CNS Stressors

Sponsor:

University of Pennsylvania

Code:

NCT07293494

Conditions

Stressor, Individual

Alcohol Impairment

Sleep Deprivation

Impairment, Cognitive

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

Alcohol Administration

Sleep Deprivation

Control

Study Details

Brief 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.

Conditions

Stressor, Individual

Alcohol Impairment

Sleep Deprivation

Impairment, Cognitive

Study ID

NCT07293494

Start date

Aug 4, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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).

Interventions

Alcohol Administration

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

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

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).

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 and Locations

Central contacts

Sierra Park-Chavar, BA

2158989667sierrap@pennmedicine.upenn.edu

Locations

University of Pennsylvania Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sierra Park-Chavar

2155735855uepstudy@pennmedicine.upenn.edu

Mathias Basner, MD, PhD, MScEpi

215-573-5866basner@pennmedicine.upenn.edu

Principal Investigator:

Mathias Basner, MD, PhD, MScEpi

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-06.