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Stressor, IndividualNeuroSTARNCT07293494

Neurobehavioral Changes Following Spaceflight Stressors

A study testing Alcohol Administration and Sleep Deprivation in people with Stressor, Individual and Alcohol Impairment, run by University of Pennsylvania at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
What is being tested?
Alcohol Administration and Sleep Deprivation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
4 Aug 2026to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sierra Park-Chavar, BA contact

2158989667

sierrap@pennmedicine.upenn.edu

United States1 site, 1 recruiting

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19104

    Sierra Park-Chavar, 2155735855, uepstudy@pennmedicine.upenn.edu

    Mathias Basner, MD, PhD, MScEpi, 215-573-5866, basner@pennmedicine.upenn.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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 six days and five nights (24 hours a day) 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 also have an adaptation night, a control condition with no daytime or nighttime interventions, and a recovery night following the sleep deprivation condition. All subjects in a group will receive the three conditions (sleep deprivation, alcohol administration and control) in the same order, but this order will vary between study runs.

Subjects will perform cognitive tests and sensorimotor tasks throughout the waking periods. They will undergo one MRI and two blood draws for each of the three conditions, for a total of three MRIs and six blood draws per subject. The scans and blood draws are timed to occur near the highest predicted level of impairment in order to capture the dose-response relationship between the stressor and performance. Combined with research from parallel rodent studies performed at a partner institution where rodents are exposed to alcohol administration, sleep deprivation and radiation, these data may allow us to estimate the performance decrements associated with exposure to radiation in humans to assess the radiation risks of spaceflight.

Being tested
Alcohol Administration, Sleep Deprivation, Control
Medical subject headings
Stress, Psychological, Sleep Deprivation, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcohol AdministrationOther

    Also called Alcohol, Intoxication

    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 DeprivationBehavioural

    Also called Sleep Restriction, Wakefulness

    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.

  • ControlOther

    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 groups in NCT07293494
Study groupRoleWhat they receive
Group A: CTRL - ALC - SD1&2ExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control
Group B: ALC - CTRL - SD1&2ExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control
Group C: SD1&2 - CTRL - ALCExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control
Group D: CTRL - SD1&2 - ALCExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control
Group E: ALC - SD1&2 - CTRLExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control
Group F: SD1&2 - ALC - CTRLExperimentalGroup 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).
Receives: Other: Alcohol Administration; Behavioral: Sleep Deprivation; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychomotor Vigilance Task (PVT) lapses

    The number of lapses in the Psychomotor Vigilance Task (PVT) in the Cognition battery, a 3-minute task that records reaction times to visual stimuli and has been validated as a sensitive measure of vigilant attention. Subjects are instructed to monitor a blank box on the screen, and to hit the space bar once a millisecond counter appears in the box and starts incrementing. The box displays the reaction time for one second then resets, with random interstimulus intervals between 2-5 seconds. Lapses are defined as response times greater than or equal to 355 milliseconds. The results are reported as the number of lapses with a standard deviation for the impaired condition and the non-impaired control state. More lapses suggest greater impairment.

    Measured: From Study Day 2 through Study Day 6 (to include each of the three conditions: ALC, CTRL, SD1&2).

Secondary outcomes (2)

  1. Cognition Test Battery Speed

    A single variable representing response time across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Subjects complete this approximately every three hours during wake. Test scores are adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Speed across cognitive domains is calculated by averaging z-scores across the 10 tests. Higher scores reflect faster speed. The final measure is reported as the least square means of the z-score.

    Scores between -0.2 and +0.2 suggest no effect on speed (0=population mean). More negative scores suggest larger negative effects (i.e. scores between -0.2 to -0.5 mean slightly slower; -0.5 to -0.8 moderately slower; scores beyond -0.8 significantly slower).

    Greater positive scores suggest larger positive effects (i.e. scores between +0.2 to +0.5 mean slightly faster; +0.5 to +0.8 moderately faster; above +0.8 significantly faster).

    Measured: From Study Day 2 through Study Day 6 (to include each of the three conditions: ALC, CTRL, SD1&2).

  2. Cognition Test Battery Accuracy

    A single variable representing accuracy across 10 Cognitive tasks that cover a range of cognitive domains with known cerebral representation. Test scores are adjusted for practice and stimulus set effects, and z-transformed based on average and standard deviation across all tests taken. Accuracy across cognitive domains is calculated by averaging z-scores across the 10 tests. Higher scores reflect better accuracy. The final measure is reported as the least square means of the z-score.

    Scores between -0.2 and +0.2 suggest no effect on accuracy (0=population mean). More negative scores suggest larger negative effects (i.e. scores between -0.2 to -0.5 mean slightly less accurate; -0.5 to -0.8 moderately less accurate; scores beyond -0.8 significantly less accurate).

    Greater positive scores suggest larger positive effects (i.e. scores between +0.2 to +0.5 mean slightly more accurate; +0.5 to +0.8 moderately more accurate; above +0.8 significantly more accurate).

    Measured: From Study Day 2 through Study Day 6 (to include each of the three conditions: ALC, CTRL, SD1&2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start4 Aug 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
After an adaptation night, subjects will be exposed to the following three scenarios in various orders across the following four nights: 1. Control night (CTRL), without any intervention; 2. Alcohol administration (ALC), where subjects will be dosed to approximately 0.08% BAC and monitored as their BAC descends to near 0.0% before sleep; 3. Acute total sleep deprivation (SD1\&2), where subjects will remain awake for 27 hours (SD1) until a daytime 3-hour nap opportunity, followed by a recovery night sleep opportunity of 9 hours (SD2). Each of these three conditions occurs in a randomized and balanced fashion across the study. There are six different possible orders that a subject can be assigned to. All subjects in one group will receive the same condition at the same time.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293494
Sponsor's protocol ID
858402
Other IDs
80JSC024NA001-NSCOR
Acronym
NeuroSTAR
Status last verified
Aug 2026
First submitted
5 Dec 2025
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kiffer F, Boerma M, Allen A. Behavioral effects of space radiation: A comprehensive review of animal studies. Life Sci Space Res (Amst). 2019 May;21:1-21. doi: 10.1016/j.lssr.2019.02.004. Epub 2019 Feb 19.

    PubMed 31101151

  • Davis CM, Allen AR, Bowles DE. Consequences of space radiation on the brain and cardiovascular system. J Environ Sci Health C Toxicol Carcinog. 2021;39(2):180-218. doi: 10.1080/26896583.2021.1891825.

    PubMed 33902387

  • Basner M, Hermosillo E, Nasrini J, Saxena S, Dinges DF, Moore TM, Gur RC. Cognition test battery: Adjusting for practice and stimulus set effects for varying administration intervals in high performing individuals. J Clin Exp Neuropsychol. 2020 Jul;42(5):516-529. doi: 10.1080/13803395.2020.1773765. Epub 2020 Jun 15.

    PubMed 32539487

  • Cekanaviciute E, Rosi S, Costes SV. Central Nervous System Responses to Simulated Galactic Cosmic Rays. Int J Mol Sci. 2018 Nov 20;19(11):3669. doi: 10.3390/ijms19113669.

    PubMed 30463349

  • Basner M, Moore TM, Hermosillo E, Nasrini J, Dinges DF, Gur RC, Johannes B. Cognition Test Battery Performance Is Associated with Simulated 6df Spacecraft Docking Performance. Aerosp Med Hum Perform. 2020 Nov 1;91(11):861-867. doi: 10.3357/AMHP.5602.2020.

    PubMed 33334406

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol Administration and Sleep Deprivation in people with Stressor, Individual and Alcohol Impairment, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sierra Park-Chavar, BA (2158989667, sierrap@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07293494, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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