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Smarter caffeine dosing could beat standard gum for All-Nighters

NCT ID NCT05588934

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a personalized caffeine dosing algorithm to standard caffeine gum for maintaining performance during 62 hours of total sleep deprivation. About 180 healthy adults aged 18-39 will complete at-home monitoring and a 4-day lab stay with no sleep. Researchers will measure reaction time, sleepiness, and side effects to see which approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
caffeine gum
What this could lead to
If it works, this could provide a smarter way to use caffeine to stay alert during sleep loss, with fewer side effects and better recovery sleep.
What could go wrong
This is an early-stage study with 180 participants, so results may not apply to everyone. The personalized algorithm may not outperform standard dosing, and caffeine can still cause jitters or sleep disruption.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 39 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-39 years of age * Must demonstrate adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz 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, on average) * Self-reported nighttime bedtimes earlier than approximately 2100 hours on average during weeknights (Sunday through Thursday) * Self-reported morning wake-up times later than approximately 0900 on average during weekdays (Monday through Friday) * Self-reported habitual napping (\> 3 times per week) * Self-reported symptoms suggestive of a sleep disorder (to include but not limited to sleep disordered breathing/sleep apnea, narcolepsy, idiopathic hypersomnia, restless leg 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 prior to screening indicative of a potential sleep disorder as determined by the examining study 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 the last 1 year) or positive nicotine/cotinine result during screening visit * 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 * 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) * 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 of psychiatric medication for any length of time * 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) * Self-reported current use of other illicit drugs (to include but not limited to benzodiazepines, 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 breast milk * Resting blood pressure above 140/90 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) * BMI ≥ 30 (Obese Class I or greater) * Clinically significant values (as determined by the reviewing study physician) for any hematology 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% of Smart-Psychomotor Vigilance Tests (PVTs) during Phase 1 (Days 2-13)

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Conditions

The condition(s) this trial relates to.

Sleep Deprivation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Arizona Psychiatry Department

    RECRUITING

    Tucson, Arizona, 85724, United States

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