CaffeineNCT05790161
Consequences of Caffeine Intake in Sleep Restricted Teenagers
A study testing Caffeine in people with Caffeine and Insufficient Sleep, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Insufficient Sleep
- What is being tested?
- Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 14 and ≤ 17
- Clinically healthy
- Signed consent form of participant and legal guardian
Who cannot join
- Inability to operate tasks or understand the study information
- Participation in other clinical trials <3 months prior to any possible study start date
- BMI P3 < BMI-PC < P97
- Any general health concerns or disorders (previous diagnosis of heart/cardiovascular/nephrological/endocrinological/diabetic/metabolic/chronobiologic/ psychiatric/neurological [particularly epilepsy and parasomnia] conditions) which may make participants vulnerable to potential negative effects of SR or caffeine or which may affect outcome measures
- Unavailability to complete the two study protocol weeks within a three-month period
- Trans meridian travel (>2 time zones) <1 month before any possible study start date
Show all 24Show fewer
- Shift work <3 months prior to any possible study start date
- Extreme chronotype MSFSC < 3:00 / MSFSC > 6:00 according to MCTQ
- Subjective sleep duration on school days <7h or >9h according to MCTQ
- Metallic prosthesis, metallic implants, or non-removable objects in the body (e.g., splinters, piercings) which affect MRI safety
- Tattoos with larger diameter than 10cm or above shoulder area, affecting MRI safety
- Claustrophobia
- Difficulties or problems in physical well-being and mental health based on the Swiss norm (T< 35) for all genders aged 12-18 according to KIDSCREEN-27
- Daily nicotine use
- Use of medications or drugs that have contraindications and/or effects on outcome measures or use of specific drugs indicated in drug test
- Use of alcohol to an extent that it is likely to have contraindications and/or effects on outcome measures
- Any indication of previous withdrawal or oversensitivity to caffeine
- Sleep quality >5 according to PSQI
- Problems of EEG compatibility
- Sleep efficiency <70%
- Identification of sleep disorders
- Pregnancy
- Deviation from the stabilisation sleep-wake schedule by +-60 mins
- Deviation from protocol sleep-wake schedule by +-30 mins
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre for Chronobiology
Basel, 4002
Carolin Reichert, Dr., + 41 77 488 42 45, carolin.reichert@upk.ch
Noëmi Capdevila, MSc, +41 79 489 11 64, noemi.capdevila@upk.ch
About this study
Official title: Consequences of Caffeine Intake in Teenagers: Effects on Sleep, Reward Processing, Risk Taking, and Underlying Cerebral Mechanisms Under Conditions of Sleep Restriction
The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. The main questions it aims to answer are:
The effects of caffeine under conditions of SR and SE:
Read more
- on sleep pressure and sleep continuity.
- on BOLD activity differences in reward related areas during a reward task (monetary incentive delay task) and on reaction times (behavioral aspect) in the same task.
- on BOLD activity differences during a risk taking task (wheel of fortune task) and on risky decision-making (behavioral aspect) in the same task.
Participants will be either in the SR or SE condition (between-subject). The protocol consists of 2x of approximately one week in which a participant will receive caffeine or placebo (within-subject) at the last two evenings.
The experiment consists of an ambulatory and a laboratory phase:
- The ambulatory phase consists of 5 nights, including 3 stabilization nights (8h sleep opportunity) prior to 2 nights consisting of either SR with 6h sleep opportunity or SE with 9.5h sleep opportunity. Participants will wear an actiwatch and fill out sleep diaries during this period.
- The laboratory phase will be the 6th evening, night and morning of the protocol and will be spent in our lab. Participants will do the following:
- treatment (caffeine vs. placebo) intake
- saliva sampling
- drug screening
- cognitive tests, including risk-taking and reward task
- filling in questionnaires (sleep diary, sleep quality, sleepiness, mood, expectancy)
- waking and sleep with EEG
The next day, participants will undergo an fMRI scan, including the following:
- resting-state scan
- structural scan
- arterial spin labeling scan
- reward task scan
- risk-taking task scan
Around the scan, participants will fill out/undergo:
- saliva sampling
- questionnaires (reward task, mood, sleepiness, expectancy)
- Conditions
- Caffeine, Insufficient Sleep
- Being tested
- Caffeine
- Keywords
- adolescence, sleep, caffeine, Risk-Taking, reward
- Medical subject headings
- Sleep Deprivation, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
2mg/kg, once before night 6 and once before the scan (either on week 1 or 2, alternating with placebo)
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction | Experimental | 3 nights with 6h sleep opportunity each. Receives: Drug: Caffeine |
| Sleep Extension | Experimental | 3 nights with 9,5h sleep opportunity each. Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nighttime Sleep SWA
Sleep at night will be quantified by polysomnographic recordings. Data will be scored epoch by epoch according to standard criteria to assign sleep stages. Spectral analysis will be performed by applying fast Fourier transformation. The key marker of sleep pressure will be slow wave activity (SWA) during NREM sleep (i.e., stage 2+3) defined as EEG power density between 0.75-4.5 Hz. To specify potential effects on SWA more precisely the investigators will additionally conduct separate analyses within this band and with separate (0.5 Hz) bins. To characterize the effects of the experimental manipulation on sleep more comprehensively, the investigators will also conduct analyses on different time bins within one night (e.g. time bin of the first 5 hours of sleep), and on different sleep stages (including wakefulness and latency to sleep), and bands other than SWA. If our resources allow, the investigators will also explore the effects of our experimental manipulation on slow wave energy.
Measured: Laboratory night week 1
Nighttime Sleep SWA
Sleep at night will be quantified by polysomnographic recordings. Data will be scored epoch by epoch according to standard criteria to assign sleep stages. Spectral analysis will be performed by applying fast Fourier transformation. The key marker of sleep pressure will be slow wave activity (SWA) during NREM sleep (i.e., stage 2+3) defined as EEG power density between 0.75-4.5 Hz. To specify potential effects on SWA more precisely the investigators will additionally conduct separate analyses within this band and with separate (0.5 Hz) bins. To characterize the effects of the experimental manipulation on sleep more comprehensively, the investigators will also conduct analyses on different time bins within one night (e.g. time bin of the first 5 hours of sleep), and on different sleep stages (including wakefulness and latency to sleep), and bands other than SWA. If our resources allow, the investigators will also explore the effects of our experimental manipulation on slow wave energy.
Measured: Laboratory night week 2
BOLD activity during reward processing
BOLD activity will be measured with a 3T MRT scanner. Brain responses will be modeled in an event-related design using a GLM for each subject at each voxel/trial. Regressors of no interest include motion parameters \& amount of gain or loss. At a within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\& vice versa). The investigators focus on BOLD activity differences in reward-related regions between anticipation of reward vs neutral events. At the random effects level, the investigators test for the effects of SR vs SE (\& vice versa) and the interaction with caffeine vs placebo. The investigators report whole-brain results. Corrections for multiple comparisons will be made accordingly. The investigators measure RTs to expected rewards, losses, and neutral trials. Task difficulty is individually adapted throughout the task.
Measured: fMRI session week 1
BOLD activity during reward processing
BOLD activity will be measured with a 3T MRT scanner. Brain responses will be modeled in an event-related design using a GLM for each subject at each voxel/trial. Regressors of no interest include motion parameters \& amount of gain or loss. At a within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\& vice versa). The investigators focus on BOLD activity differences in reward-related regions between anticipation of reward vs neutral events. At the random effects level, the investigators test for the effects of SR vs SE (\& vice versa) and the interaction with caffeine vs placebo. The investigators report whole-brain results. Corrections for multiple comparisons will be made accordingly. The investigators measure RTs to expected rewards, losses, and neutral trials. Task difficulty is individually adapted throughout the task.
Measured: fMRI session week 2
BOLD activity during risk-decision making (RDM)
BOLD activity/brain responses will be measured as above. Regressors of no interest additionally include risk probability, indicated amount of gain \& difference in expected value between safe and risky option. At within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\&vice versa). If number of events is sufficient, the investigators focus on BOLD activity differences in regions related to RDM between safe/risky choices. At the random effects level, the investigators test for effects of SR vs SE (\&vice versa) \& the interaction with caffeine vs placebo. The investigators report whole-brain results Connectivity analyses to characterize brain activity underlying RDM are planned.
Measured: fMRI session week 1
BOLD activity during risk-decision making (RDM)
BOLD activity/brain responses will be measured as above. Regressors of no interest additionally include risk probability, indicated amount of gain \& difference in expected value between safe and risky option. At within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\&vice versa). If number of events is sufficient, the investigators focus on BOLD activity differences in regions related to RDM between safe/risky choices. At the random effects level, the investigators test for effects of SR vs SE (\&vice versa) \& the interaction with caffeine vs placebo. The investigators report whole-brain results Connectivity analyses to characterize brain activity underlying RDM are planned.
Measured: fMRI session week 2
Secondary outcomes (9)
Resting state(rs) functional connectivity (FC)
Rs-FC will be ascertained via BOLD measured with MRI in a 3T Siemens scanner (Prisma; Siemens AG, Erlangen, Germany) using a 24-channel head coil. The standard three-dimensional magnetization-prepared rapid acquisition (MPRAGE) sequence with gradient echo (1x1x1mm, TR=2000ms, TI= 1000ms, TE=3.37ms, FA=8°) will obtain T1-weighted images to depict morphological aspects of the brain. To depict BOLD activity during resting T2*-weighted echo-planar image (EPI) sequences (TR = 2000, TE = 35ms, FOV = 216mm, voxel size = 2.4 mm3, matrix size 90*90, 50 slices) will be performed twice for 6-minutes. Foam and inflatable pads will be used to reduce head motion. Participants will be required to have eyes open and stare at a fixation cross to provide greater reliability of within-network connections and reduce experimental variability. Heart rate and respiration will be recorded by Siemens MRI scanner installed hardware.
Measured: fMRI session week 1; fMRI session week 2
BOLD activity during reward feedback
BOLD activity will be measured with a 3T MRT scanner. Brain responses will first be modeled in an event-related design using a GLM for each subject at each voxel and each trial. Regressors of no interest include motion parameters and indicated amount of gain or loss (high vs low) and the type of feedback. At a within-subject level, the investigators contrast BOLD activity in caffeine vs placebo (and vice versa). The investigators focus on differences in reward-related regions between feedback of successful reward trials vs successful neutral trials. The investigators may run analyses contrasting feedback of successful reward trials vs feedback of neutral trials. At the 2nd (random effects) level, the investigators test for effects of SR vs SE (and vice versa) and interaction with caffeine vs placebo. The investigators correct for multiple comparisons within reward-related regions. The investigators report whole-brain results, corrected for whole brain multiple comparisons.
Measured: fMRI session week 1; fMRI session week 2
Vigilance
Vigilance performance will be quantified by mean 1/RT for all reaction times in the Psychometric Vigilance Task. The investigators may also report the number of lapses (trials with RT > 500ms) if meaningful and may explore the effects of our experimental manipulation on other typical outcome variables of the PVT.
Measured: Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 2
Working Memory
Working Memory will be quantified by RT, number of n-back reached, and accuracy (number of missings, number of hits) in an adaptive n-back task. The n-back task is a computer-based task to assess working memory performance. The participant is presented with a sequence of stimuli and must indicate when the current stimulus matches the one from n steps earlier in the sequence. The investigators will use an adaptive n-back version where the n steps adapt to individual performance
Measured: LaboratoryLaboratory evening (1 time) and morning (1 time) week 1; Laboratory evening (1 time) and morning (1 time) week 2
Inihibition
Inhibition performance will be quantified by the number of commission and omission errors in a go/nogo task. The investigators will also report RTs. The participants will be asked to press a button in response to visually presented stimuli, but to avoid responding to a rarer nontarget.
Measured: Laboratory evening (2 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (2 times) and morning (1 time SE & 2 times SR) week 2
Subjective Sleepiness
Subjective sleepiness will be quantified by the Karolinska Sleepiness Scale (KSS). This is a 9-point scale (1 = extremely, alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep) which the participants are asked to fill in.
Measured: Laboratory evening (7 times) and morning (2 times SE & 4 times SR ) week 1; Laboratory evening (7 times) and morning (2 times SE & 4 times SR ) week 2
Circadian timing (DLMO)
The investigators will measure melatonin levels in saliva samples using biochemical analysis. The investigators will report melatonin levels and melatonin suppression. Dim-light melatonin onset (DLMO) will be the indicator for the onset of the biological night and quantified using the hockey-stick method.
Measured: laboratory phase week 1 (9 samples SE & 11 samples SR) & fMRI Session week 1 (3 samples) ;laboratory phase week 2 (9 samples SE & 11 samples SR) & fMRI Session week 2 (3 samples)
Objective Sleepiness
The investigators will quantify sleepiness objectively via EEG delta and theta activity (ranges ~0.5-8 Hz) in a 3-minute Waking-EEG where participants will be asked to stare at a fixation cross or during task performance.
Measured: Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (2 times) and morning (1 time) week 2
Subjective Sleep Quality
To measure subjective sleep quality, the investigators use the Leeds Sleep Evaluation Questionnaire (LSEQ) administered in the morning after wake-up. The questionnaire results in values on the four dimensions: Getting to Sleep, Quality of Sleep, Awake Following Sleep, and Behaviour Following Wakening.
Measured: Laboratory morning week 1 (1 time); Laboratory morning (1 time) week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start31 Mar 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Within-Design regarding treatment (caffeine vs. placebo). Between-Design regarding sleep manipulation (sleep restriction vs. sleep manipulation)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University of Basel, University Hospital, Basel, Switzerland, University of Pittsburgh, University of Liege
- Responsible party
- Principal investigator, Carolin Reichert, Psychiatric Hospital of the University of Basel
- Investigators
- Carolin Reichert, Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790161
- Sponsor's protocol ID
- CaReTeens
- Status last verified
- May 2023
- First submitted
- 4 Mar 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of Caffeine Intake in Teenagers: Effects on Sleep, Reward Processing, Risk Taking, and Underlying Cerebral Mechanisms Under Conditions of Sleep Restriction
- ClinicalTrials.gov ID
- NCT05790161
- Acronym / sponsor ID
- CaReTeens
- Conditions
- Caffeine, Insufficient Sleep
- Keywords
- adolescence, sleep, caffeine, Risk-Taking, reward
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Psychiatric Hospital of the University of BaselUniversity, hospital or other
- Collaborators
- University of Zurich, University of Basel, University Hospital, Basel, Switzerland, University of Pittsburgh, University of Liege
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. The main questions it aims to answer are:
The effects of caffeine under conditions of SR and SE:
- on sleep pressure and sleep continuity.
- on BOLD activity differences in reward related areas during a reward task (monetary incentive delay task) and on reaction times (behavioral aspect) in the same task.
- on BOLD activity differences during a risk taking task (wheel of fortune task) and on risky decision-making (behavioral aspect) in the same task.
Participants will be either in the SR or SE condition (between-subject). The protocol consists of 2x of approximately one week in which a participant will receive caffeine or placebo (within-subject) at the last two evenings.
The experiment consists of an ambulatory and a laboratory phase:
- The ambulatory phase consists of 5 nights, including 3 stabilization nights (8h sleep opportunity) prior to 2 nights consisting of either SR with 6h sleep opportunity or SE with 9.5h sleep opportunity. Participants will wear an actiwatch and fill out sleep diaries during this period.
- The laboratory phase will be the 6th evening, night and morning of the protocol and will be spent in our lab. Participants will do the following:
- treatment (caffeine vs. placebo) intake
- saliva sampling
- drug screening
- cognitive tests, including risk-taking and reward task
- filling in questionnaires (sleep diary, sleep quality, sleepiness, mood, expectancy)
- waking and sleep with EEG
The next day, participants will undergo an fMRI scan, including the following:
- resting-state scan
- structural scan
- arterial spin labeling scan
- reward task scan
- risk-taking task scan
Around the scan, participants will fill out/undergo:
- saliva sampling
- questionnaires (reward task, mood, sleepiness, expectancy)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Within-Design regarding treatment (caffeine vs. placebo). Between-Design regarding sleep manipulation (sleep restriction vs. sleep manipulation)
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction | Experimental | Drug: Caffeine3 nights with 6h sleep opportunity each. |
| Sleep Extension | Experimental | Drug: Caffeine3 nights with 9,5h sleep opportunity each. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age ≥ 14 and ≤ 17
- Clinically healthy
- Signed consent form of participant and legal guardian
Key exclusion criteria (24 listed)
- Inability to operate tasks or understand the study information
- Participation in other clinical trials <3 months prior to any possible study start date
- BMI P3 < BMI-PC < P97
- Any general health concerns or disorders (previous diagnosis of heart/cardiovascular/nephrological/endocrinological/diabetic/metabolic/chronobiologic/ psychiatric/neurological [particularly epilepsy and parasomnia] conditions) which may make participants vulnerable to potential negative effects of SR or caffeine or which may affect outcome measures
- Unavailability to complete the two study protocol weeks within a three-month period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine2mg/kg, once before night 6 and once before the scan (either on week 1 or 2, alternating with placebo) | Drug | Sleep Extension, Sleep Restriction |
Primary outcome
Nighttime Sleep SWA
Time frame: Laboratory night week 1
Sleep at night will be quantified by polysomnographic recordings. Data will be scored epoch by epoch according to standard criteria to assign sleep stages. Spectral analysis will be performed by applying fast Fourier transformation. The key marker of sleep pressure will be slow wave activity (SWA) during NREM sleep (i.e., stage 2+3) defined as EEG power density between 0.75-4.5 Hz. To specify potential effects on SWA more precisely the investigators will additionally conduct separate analyses within this band and with separate (0.5 Hz) bins. To characterize the effects of the experimental manipulation on sleep more comprehensively, the investigators will also conduct analyses on different time bins within one night (e.g. time bin of the first 5 hours of sleep), and on different sleep stages (including wakefulness and latency to sleep), and bands other than SWA. If our resources allow, the investigators will also explore the effects of our experimental manipulation on slow wave energy.
Nighttime Sleep SWA
Time frame: Laboratory night week 2
Sleep at night will be quantified by polysomnographic recordings. Data will be scored epoch by epoch according to standard criteria to assign sleep stages. Spectral analysis will be performed by applying fast Fourier transformation. The key marker of sleep pressure will be slow wave activity (SWA) during NREM sleep (i.e., stage 2+3) defined as EEG power density between 0.75-4.5 Hz. To specify potential effects on SWA more precisely the investigators will additionally conduct separate analyses within this band and with separate (0.5 Hz) bins. To characterize the effects of the experimental manipulation on sleep more comprehensively, the investigators will also conduct analyses on different time bins within one night (e.g. time bin of the first 5 hours of sleep), and on different sleep stages (including wakefulness and latency to sleep), and bands other than SWA. If our resources allow, the investigators will also explore the effects of our experimental manipulation on slow wave energy.
BOLD activity during reward processing
Time frame: fMRI session week 1
BOLD activity will be measured with a 3T MRT scanner. Brain responses will be modeled in an event-related design using a GLM for each subject at each voxel/trial. Regressors of no interest include motion parameters \& amount of gain or loss. At a within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\& vice versa). The investigators focus on BOLD activity differences in reward-related regions between anticipation of reward vs neutral events. At the random effects level, the investigators test for the effects of SR vs SE (\& vice versa) and the interaction with caffeine vs placebo. The investigators report whole-brain results. Corrections for multiple comparisons will be made accordingly. The investigators measure RTs to expected rewards, losses, and neutral trials. Task difficulty is individually adapted throughout the task.
BOLD activity during reward processing
Time frame: fMRI session week 2
BOLD activity will be measured with a 3T MRT scanner. Brain responses will be modeled in an event-related design using a GLM for each subject at each voxel/trial. Regressors of no interest include motion parameters \& amount of gain or loss. At a within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\& vice versa). The investigators focus on BOLD activity differences in reward-related regions between anticipation of reward vs neutral events. At the random effects level, the investigators test for the effects of SR vs SE (\& vice versa) and the interaction with caffeine vs placebo. The investigators report whole-brain results. Corrections for multiple comparisons will be made accordingly. The investigators measure RTs to expected rewards, losses, and neutral trials. Task difficulty is individually adapted throughout the task.
BOLD activity during risk-decision making (RDM)
Time frame: fMRI session week 1
BOLD activity/brain responses will be measured as above. Regressors of no interest additionally include risk probability, indicated amount of gain \& difference in expected value between safe and risky option. At within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\&vice versa). If number of events is sufficient, the investigators focus on BOLD activity differences in regions related to RDM between safe/risky choices. At the random effects level, the investigators test for effects of SR vs SE (\&vice versa) \& the interaction with caffeine vs placebo. The investigators report whole-brain results Connectivity analyses to characterize brain activity underlying RDM are planned.
BOLD activity during risk-decision making (RDM)
Time frame: fMRI session week 2
BOLD activity/brain responses will be measured as above. Regressors of no interest additionally include risk probability, indicated amount of gain \& difference in expected value between safe and risky option. At within-subject level, the investigators contrast BOLD activity in caffeine vs placebo conditions (\&vice versa). If number of events is sufficient, the investigators focus on BOLD activity differences in regions related to RDM between safe/risky choices. At the random effects level, the investigators test for effects of SR vs SE (\&vice versa) \& the interaction with caffeine vs placebo. The investigators report whole-brain results Connectivity analyses to characterize brain activity underlying RDM are planned.
9 secondary outcomes
Resting state(rs) functional connectivity (FC)
Time frame: fMRI session week 1; fMRI session week 2
BOLD activity during reward feedback
Time frame: fMRI session week 1; fMRI session week 2
Vigilance
Time frame: Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 2
Working Memory
Time frame: LaboratoryLaboratory evening (1 time) and morning (1 time) week 1; Laboratory evening (1 time) and morning (1 time) week 2
Inihibition
Time frame: Laboratory evening (2 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (2 times) and morning (1 time SE & 2 times SR) week 2
Subjective Sleepiness
Time frame: Laboratory evening (7 times) and morning (2 times SE & 4 times SR ) week 1; Laboratory evening (7 times) and morning (2 times SE & 4 times SR ) week 2
Circadian timing (DLMO)
Time frame: laboratory phase week 1 (9 samples SE & 11 samples SR) & fMRI Session week 1 (3 samples) ;laboratory phase week 2 (9 samples SE & 11 samples SR) & fMRI Session week 2 (3 samples)
Objective Sleepiness
Time frame: Laboratory evening (3 times) and morning (1 time SE & 2 times SR) week 1; Laboratory evening (2 times) and morning (1 time) week 2
Subjective Sleep Quality
Time frame: Laboratory morning week 1 (1 time); Laboratory morning (1 time) week 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Reichert, Dr. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Caffeine and Insufficient Sleep, run by Psychiatric Hospital of the University of Basel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolin Reichert, Dr. (+41 77 488 42 45, carolin.reichert@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nighttime Sleep SWA (time frame: Laboratory night week 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.