Neurobehavioral Changes Following Spaceflight Stressors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-60
SponsorUniversity of Pennsylvania
About this trial
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
Qualifiers
Age between 25-60 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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Alcohol Administration
- Sleep Deprivation
- Control
Treatment groups
56 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
University of Florida
Collaborator
Cornell University/Weill Cornell Medical Center
Collaborator
National Aeronautics and Space Administration (NASA)
Collaborator
University of Nevada, Las Vegas
Collaborator
Loma Linda University
Collaborator
Source ClinicalTrials.gov