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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
| Biotechnology High Performance Computing Software Applications Institute | UNKNOWN |
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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.
Participants will be asked to:
Researchers 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.
This clinical trial will be examining whether the 2B-Alert Caffeine Optimization algorithm provides greater performance optimization, side effect minimization, and quality of recovery sleep during sleep deprivation compared to the standard published recommendations for caffeine use. The objective of this clinical trial will be to conduct a head-to-head comparison between the 2B-Alert app versus a commonly recommended caffeine dosing regimen for sustaining optimal performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The specific aims are to: Determine the effectiveness of 2B-Alert versus standard caffeine dosing on psychomotor vigilance, subjective sleepiness, and cognition on single and multiple nights of sleep deprivation; Determine the effectiveness of 2B-Alert versus standard caffeine dosing at mitigating physiological and emotional side effects; Determine the effectiveness of 2B-Alert versus standard caffeine dosing at minimizing disruptions in recovery sleep.
This clinical trial will consist of three phases. Phase 1 includes the enrollment visit where participants will come into the lab, complete baseline personality and mood testing, and be given the actigraph watch and phone with the 2B-Alert app. Then the participant will undergo 13-days of at-home psychomotor vigilance testing and sleep data collection.
Phase 2 begins with the participant arrives at the lab for the 4-day in-lab portion of the study. During this phase the participant will complete a night of baseline sleep using polysomnography to collect sleep data. At the end of baseline sleep, the participant will begin the 62-hour sleep deprivation portion. During the deprivation portion, data will be collected periodically on the participants psychomotor vigilance. After 37-49 hours of continuous sleep deprivation participants will be administered either caffeine gum or placebo gum.
There are four different experimental conditions and one control condition that determines the ratio of caffeine gum to placebo gum that is administered to participants:
After the 62-hour period of total sleep deprivation, participants will complete Phase 3, a night of recovery sleep; During this phase, participants' sleep data will be collected using polysomnography. After the night of recovery sleep participants will remain in the lab for further psychomotor vigilance testing. Once this is complete individuals will be released from the lab and their participation will be complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Dose Both Nights | Placebo Comparator | Participants will be administer non-caffeinated, placebo gum during both nights of Phase 2. |
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| Standard Caffeine Dose Both Nights | Active Comparator | Participants will be administer the standard caffeine recommendation (200mg/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during both nights of Phase 2. |
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| Optimized Caffeine Dose Both Nights | Active Comparator | Participants will be administer the optimized caffeine recommendation (0-300mg/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during both nights of Phase 2. |
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| Placebo Dose 1st Night/Standard Caffeine Dose 2nd Night | Active Comparator | 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/2 hr. up to 800mg/24 hr.) using caffeinated and non-caffeinated gum during the second night of Phase 2. |
|
| Placebo Dose 1st Night/Optimized Caffeine Dose 2nd Night |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine Gum | Dietary Supplement | Commercially available caffeinated gum that contains 100mg of caffeine per piece of gum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean psychomotor vigilance test reaction time | The mean response time to psychomotor vigilance tests during the Peak Alertness Window. | Peak Alertness Window: During each overnight sleep deprivation period from 3:00am to 9:00am |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William D Killgore, Ph.D. | Contact | (520) 621-0605 | killgore@psychiatry.arizona.edu | |
| Lindsey Hildebrand, MA | Contact | (520) 626-2203 | hildebrandll@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85719 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16313140 | Background | Kamimori GH, Johnson D, Thorne D, Belenky G. Multiple caffeine doses maintain vigilance during early morning operations. Aviat Space Environ Med. 2005 Nov;76(11):1046-50. | |
| 19238808 | Background | Killgore WD, Kahn-Greene ET, Grugle NL, Killgore DB, Balkin TJ. Sustaining executive functions during sleep deprivation: A comparison of caffeine, dextroamphetamine, and modafinil. Sleep. 2009 Feb;32(2):205-16. doi: 10.1093/sleep/32.2.205. |
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There is no plan to make individual participant data available to other researchers. All data that will be shared from this clinical trial will be shared in summary data sets.
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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There are four different experimental conditions and one control condition that determines the ratio of caffeine gum to placebo gum that is administered to participants.
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Participants will not have any knowledge of which of the five condition groups they are apart of during or after the study.
The investigator will not have any knowledge of which of the five condition groups the participant is apart of during or after the study.
A third party will prepare the caffeine dosing and not participate in the administration to avoid knowledge of what participants are in what categories.
| Active Comparator |
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/2 hr. up to 800mg/24 hr.) potentially using caffeinated and non-caffeinated gum, depending on optimized dosage, during the second night of Phase 2. |
|
|
| Placebo Gum | Other | Commercially available non-caffeinated gum. |
|
| University of Arizona Psychiatry Department | Recruiting | Tucson | Arizona | 85724 | United States |
|
| 33364521 | Background | Killgore WDS, Kamimori GH. Multiple caffeine doses maintain vigilance, attention, complex motor sequence expression, and manual dexterity during 77 hours of total sleep deprivation. Neurobiol Sleep Circadian Rhythms. 2020 May 31;9:100051. doi: 10.1016/j.nbscr.2020.100051. eCollection 2020 Nov. |
| 28436072 | Background | Liu J, Ramakrishnan S, Laxminarayan S, Balkin TJ, Reifman J. Real-time individualization of the unified model of performance. J Sleep Res. 2017 Dec;26(6):820-831. doi: 10.1111/jsr.12535. Epub 2017 Apr 24. |
| 26518594 | Background | Ramakrishnan S, Wesensten NJ, Balkin TJ, Reifman J. A Unified Model of Performance: Validation of its Predictions across Different Sleep/Wake Schedules. Sleep. 2016 Jan 1;39(1):249-62. doi: 10.5665/sleep.5358. |
| 27397562 | Background | Ramakrishnan S, Wesensten NJ, Kamimori GH, Moon JE, Balkin TJ, Reifman J. A Unified Model of Performance for Predicting the Effects of Sleep and Caffeine. Sleep. 2016 Oct 1;39(10):1827-1841. doi: 10.5665/sleep.6164. |
| 27634801 | Background | Reifman J, Kumar K, Wesensten NJ, Tountas NA, Balkin TJ, Ramakrishnan S. 2B-Alert Web: An Open-Access Tool for Predicting the Effects of Sleep/Wake Schedules and Caffeine Consumption on Neurobehavioral Performance. Sleep. 2016 Dec 1;39(12):2157-2159. doi: 10.5665/sleep.6318. |
| 29808510 | Background | Vital-Lopez FG, Ramakrishnan S, Doty TJ, Balkin TJ, Reifman J. Caffeine dosing strategies to optimize alertness during sleep loss. J Sleep Res. 2018 Oct;27(5):e12711. doi: 10.1111/jsr.12711. Epub 2018 May 28. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |