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| Name | Class |
|---|---|
| University of Zurich | OTHER |
| University of Basel | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
| University of Pittsburgh |
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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:
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 next day, participants will undergo an fMRI scan, including the following:
Around the scan, participants will fill out/undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Restriction | Experimental | 3 nights with 6h sleep opportunity each. |
|
| Sleep Extension | Experimental | 3 nights with 9,5h sleep opportunity each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine | Drug | 2mg/kg, once before night 6 and once before the scan (either on week 1 or 2, alternating with placebo) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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=8Ā°) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolin Reichert, Dr. | Contact | +41 77 488 42 45 | carolin.reichert@upk.ch | |
| Noƫmi Capdevila, MSc | Contact | +41 79 489 11 64 | noemi.capdevila@upk.ch |
| Name | Affiliation | Role |
|---|---|---|
| Carolin Reichert, Dr. | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Chronobiology | Recruiting | Basel | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| OTHER |
| University of Liege | OTHER |
Within-Design regarding treatment (caffeine vs. placebo). Between-Design regarding sleep manipulation (sleep restriction vs. sleep manipulation)
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doubleblind regarding treatment no blinding regarding sleep manipulation
| 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. | 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. | 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. | fMRI session week 2 |
| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | Laboratory morning week 1 (1 time); Laboratory morning (1 time) week 2 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |