Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT07293494
Eligibility Criteria:
Inclusion Criteria:
* 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.
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT07293494
Study Brief:
Protocol Section:
NCT07293494