[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484506":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":44,"centralContacts":45,"locations":55,"responsibleParty":88,"collaborators":90,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":44,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":57,"whyStopped":44,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University of Arizona","OTHER",[8,14,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Dose Both Nights","PLACEBO_COMPARATOR","Participants will be administer non-caffeinated, placebo gum during both nights of Phase 2.",[13],"Other: Placebo Gum",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Caffeine Dose Both Nights","ACTIVE_COMPARATOR","Participants will be administer the standard caffeine recommendation (200mg\u002F2 hr. up to 800mg\u002F24 hr.) using caffeinated and non-caffeinated gum during both nights of Phase 2.",[19,13],"Dietary Supplement: Caffeine Gum",{"label":21,"type":16,"description":22,"interventionNames":23},"Optimized Caffeine Dose Both Nights","Participants will be administer the optimized caffeine recommendation (0-300mg\u002F2 hr. up to 800mg\u002F24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during both nights of Phase 2.",[19,13],{"label":25,"type":16,"description":26,"interventionNames":27},"Placebo Dose 1st Night\u002FStandard Caffeine Dose 2nd Night","Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the standard caffeine recommendation (200mg\u002F2 hr. up to 800mg\u002F24 hr.) using caffeinated and non-caffeinated gum during the second night of Phase 2.",[19,13],{"label":29,"type":16,"description":30,"interventionNames":31},"Placebo Dose 1st Night\u002FOptimized Caffeine Dose 2nd Night","Participants will be administer non-caffeinated, placebo gum during the first night of Phase 2. Then, participants will be administer the optimized caffeine recommendation (0-300mg\u002F2 hr. up to 800mg\u002F24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during the second night of Phase 2.",[19,13],[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DIETARY_SUPPLEMENT","Caffeine Gum","Commercially available caffeinated gum that contains 100mg of caffeine per piece of gum.",[21,29,25,15],[39],"Military Energy Gum",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Placebo Gum","Commercially available non-caffeinated gum.",[21,29,25,9,15],null,[46,51],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"William D Killgore, Ph.D.","CONTACT","(520) 621-0605","killgore@psychiatry.arizona.edu",{"name":52,"role":48,"phone":53,"phoneExt":44,"email":54},"Lindsey Hildebrand, MA","(520) 626-2203","hildebrandll@arizona.edu",[56,76],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Tucson","Arizona","85719","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-110.92648,32.22174,{"lat":67,"lon":66},[70,73],{"name":71,"role":48,"phone":72,"phoneExt":44,"email":50},"William DS Killgore","520-621-0605",{"name":74,"role":48,"phone":44,"phoneExt":44,"email":75},"Camryn Wellman","camrynwellman@arizona.edu",{"facility":77,"status":57,"city":58,"state":59,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"University of Arizona Psychiatry Department","85724",{"type":64,"coordinates":80},[66,67],{"lat":67,"lon":66},[83,85],{"name":84,"role":48,"phone":72,"phoneExt":44,"email":50},"William D Killgore, PhD",{"name":86,"role":87,"phone":44,"phoneExt":44,"email":44},"William Killgore, Ph.D.","PRINCIPAL_INVESTIGATOR",{"type":89,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[91,94],{"name":92,"class":93},"U.S. Army Medical Research Acquisition Activity","FED",{"name":95,"class":96},"Biotechnology High Performance Computing Software Applications Institute","UNKNOWN","100484506","caffeine-optimization-versus-standard-caffeine-dosage-2b-2-100484506",false,"NCT05588934","Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)","A Head-to-Head Comparison of the 2B-Alert Caffeine Optimization Algorithm Versus Standard Caffeine Dosing on Performance During Sleep Deprivation (2B-2)","2B-2","Inclusion Criteria:\n\n* Age 18-39 years of age\n* Must demonstrate adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz\n\nExclusion Criteria:\n\n* 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, on average)\n* Self-reported nighttime bedtimes earlier than approximately 2100 hours on average during weeknights (Sunday through Thursday)\n* Self-reported morning wake-up times later than approximately 0900 on average during weekdays (Monday through Friday)\n* Self-reported habitual napping (\\> 3 times per week)\n* Self-reported symptoms suggestive of a sleep disorder (to include but not limited to sleep disordered breathing\u002Fsleep apnea, narcolepsy, idiopathic hypersomnia, restless leg syndrome, parasomnias, rapid eye movement (REM) behavior disorder, etc.)\n* History of a sleep disorder (to include all of the above)\n* Any use of prescription or over-the-counter sleep aids during the 6-month period prior to screening indicative of a potential sleep disorder as determined by the examining study physician\n* History of neurologic disorder (e.g., seizure disorder, amnesia for any reason, hydrocephalus, multiple sclerosis)\n* Self-reported caffeine use \\> 400 mg per day on average\n* Score of 14 or above on the Beck Depression Inventory (BDI)\n* Score of 41 or above on the Spielberger Trait Anxiety Inventory (STAI-T)\n* Score below 31 or above 69 on the Morningness-Eveningness Questionnaire\n* Self-reported regular nicotine use (\\> 1 cigarette or equivalent per week) within the last 1 year) or positive nicotine\u002Fcotinine result during screening visit\n* Self-reported heavy alcohol use (≥14 drinks per week or as determined by the examining study physician) or positive saliva alcohol result during screening visit\n* History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction)\n* Underlying acute or chronic pulmonary disease requiring daily inhaler use\n* Kidney disease or kidney abnormalities\n* Liver disease or liver abnormalities\n* Self-reported history of psychiatric disorder requiring hospitalization or use of psychiatric medication for any length of time\n* Self-reported use of products or drugs that cannot be safely discontinued during in-laboratory phases (determined on a case-by-case basis by the examining study physician)\n* Self-reported current use of other illicit drugs (to include but not limited to benzodiazepines, amphetamines, cocaine, marijuana) or positive urine drug screen\n* (Females only) positive urine pregnancy result\n* (Females only) self-reported or suspected current breast-feeding or collecting breast milk\n* Resting blood pressure above 140\u002F90 or resting pulse \\> 110 beats per minute (if a physician performs a repeat measurement, \\~20 minutes after original measure, and it is within range, volunteer will not be excluded)\n* BMI ≥ 30 (Obese Class I or greater)\n* Clinically significant values (as determined by the reviewing study physician) for any hematology or chemistry parameter\n* Inability to read and sign consent\n* (Military only) failure to obtain required approved official leave to participate\n* Failure to cooperate with requirements of the study, e.g. failure to complete 80% of Smart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)",true,"ALL","18 Years","39 Years",{"count":110,"type":111},180,"ESTIMATED","INTERVENTIONAL",[114],"NA","This clinical trial will be a comparison between personalized recommended caffeine dosing regimen versus the standard recommended caffeine dosing regimen for sustaining performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The questions this study aims to answer are: Whether the personalized caffeine recommendations improve vigilance, sleepiness, and cognition after total sleep deprivation, compared to standard recommendations; Whether the personalized caffeine recommendation better addresses the physical and emotional side effects of total sleep deprivation, compared to standard recommendations; And whether personalized caffeine recommendations aids in better recovery sleep after total sleep deprivation, compared to standard recommendations.\n\nParticipants will be asked to:\n\n1. Complete a 13-day at-home portion, wearing an actigraph watch to measure activity and sleep, and complete motor vigilance tests up to six times a day.\n2. Complete a 4-day in-lab portion, where participants will have to complete one night of baseline sleep, undergo 62-hours of total sleep deprivation, and then complete one night of recovery sleep.\n3. During the in-lab portion of the study, participants will be asked to complete more motor vigilance tests.\n\nResearchers will be comparing the personalized caffeine recommendation group against the standard caffeine recommendation to see if it is better at addressing each of the main questions.",[117,118],"Sleep Deprivation","Caffeine",[120,121],"SLEEP","CAFFEINE","2025-10-31",{"date":124,"type":125},"2025-11-04","ACTUAL",{"date":127,"type":125},"2023-06-09",{"date":129,"type":111},"2026-03",{"name":5,"class":6},2]