Last updated: May 7, 2024
Sponsor: University of Arizona
Overall Status: Active - Recruiting
Phase
N/A
Condition
Insomnia
Sleep Disorders
Treatment
Placebo Gum
Caffeine Gum
Clinical Study ID
NCT05588934
STUDY00001953
Ages 18-39 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-39 years of age
- Must demonstrate adequate comprehension of the protocol by achieving a score of atleast 80% correct on a short multiple-choice quiz
Exclusion
Exclusion Criteria:
- Self-reported habitual nightly sleep amounts outside the target range of approximately 6-9 hours (i.e., less than 6 hours per night or more than 9 hours per night, onaverage)
- Self-reported nighttime bedtimes earlier than approximately 2100 hours on averageduring weeknights (Sunday through Thursday)
- Self-reported morning wake-up times later than approximately 0900 on average duringweekdays (Monday through Friday)
- Self-reported habitual napping (> 3 times per week)
- Self-reported symptoms suggestive of a sleep disorder (to include but not limited tosleep disordered breathing/sleep apnea, narcolepsy, idiopathic hypersomnia, restlessleg syndrome, parasomnias, rapid eye movement (REM) behavior disorder, etc.)
- History of a sleep disorder (to include all of the above)
- Any use of prescription or over-the-counter sleep aids during the 6-month period priorto screening indicative of a potential sleep disorder as determined by the examiningstudy physician
- History of neurologic disorder (e.g., seizure disorder, amnesia for any reason,hydrocephalus, multiple sclerosis)
- Self-reported caffeine use > 400 mg per day on average
- Score of 14 or above on the Beck Depression Inventory (BDI)
- Score of 41 or above on the Spielberger Trait Anxiety Inventory (STAI-T)
- Score below 31 or above 69 on the Morningness-Eveningness Questionnaire
- Self-reported regular nicotine use (> 1 cigarette or equivalent per week) within thelast 1 year) or positive nicotine/cotinine result during screening visit
- Self-reported heavy alcohol use (≥14 drinks per week or as determined by the examiningstudy physician) or positive saliva alcohol result during screening visit
- History of cardiovascular disease (to include but not limited to arrhythmias, valvularheart disease, congestive heart failure, history of sudden cardiac death or myocardialinfarction)
- Underlying acute or chronic pulmonary disease requiring daily inhaler use
- Kidney disease or kidney abnormalities
- Liver disease or liver abnormalities
- Self-reported history of psychiatric disorder requiring hospitalization or use ofpsychiatric medication for any length of time
- Self-reported use of products or drugs that cannot be safely discontinued duringin-laboratory phases (determined on a case-by-case basis by the examining studyphysician)
- Self-reported current use of other illicit drugs (to include but not limited tobenzodiazepines, amphetamines, cocaine, marijuana) or positive urine drug screen
- (Females only) positive urine pregnancy result
- (Females only) self-reported or suspected current breast-feeding or collecting breastmilk
- Resting blood pressure above 140/90 or resting pulse > 110 beats per minute (if aphysician performs a repeat measurement, ~20 minutes after original measure, and it iswithin range, volunteer will not be excluded)
- BMI ≥ 30 (Obese Class I or greater)
- Clinically significant values (as determined by the reviewing study physician) for anyhematology or chemistry parameter
- Inability to read and sign consent
- (Military only) failure to obtain required approved official leave to participate
- Failure to cooperate with requirements of the study, e.g. failure to complete 80% ofSmart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)
Study Design
Total Participants: 180
Treatment Group(s): 2
Primary Treatment: Placebo Gum
Phase:
Study Start date:
June 09, 2023
Estimated Completion Date:
March 31, 2026
Study Description
Connect with a study center
University of Arizona
Tucson, Arizona 85719
United StatesActive - Recruiting
University of Arizona Psychiatry Department
Tucson, Arizona 85724
United StatesActive - Recruiting
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