Consequences of Caffeine Intake in Sleep Restricted Teenagers

NCT05790161 | Unknown DMC

• 1 other identifier: CaReTeens
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Caffeine; Insufficient Sleep

Keywords

adolescence; sleep; caffeine; Risk-Taking; reward

Outcome Measures

Primary Outcomes (6)

• 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.

  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

Secondary Outcomes (9)

• Resting state(rs) functional connectivity (FC)

  fMRI session week 1; fMRI session week 2

• BOLD activity during reward feedback

  fMRI session week 1; fMRI session week 2

• Vigilance

  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

  LaboratoryLaboratory evening (1 time) and morning (1 time) week 1; Laboratory evening (1 time) and morning (1 time) week 2

• Inihibition

  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

Study Arms (2)

Sleep Restriction

EXPERIMENTAL

3 nights with 6h sleep opportunity each.

Drug: Caffeine

Sleep Extension

EXPERIMENTAL

3 nights with 9,5h sleep opportunity each.

Drug: Caffeine

Interventions

Caffeine DRUG

2mg/kg, once before night 6 and once before the scan (either on week 1 or 2, alternating with placebo)

Sleep Extension; Sleep Restriction

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 14 and ≤ 17
• Clinically healthy
• Signed consent form of participant and legal guardian

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Psychiatric Hospital of the University of Basel: lead
• University of Zurich: collaborator
• University of Basel: collaborator
• University Hospital, Basel, Switzerland: collaborator
• University of Pittsburgh: collaborator
• University of Liege: collaborator

Study Sites (1)

Centre for Chronobiology

Basel, 4002, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Deprivation; Risk-Taking

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Carolin Reichert, Dr.

  University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolin Reichert, Dr.

CONTACT

+41 77 488 42 45; carolin.reichert@upk.ch

Noëmi Capdevila, MSc

CONTACT

+41 79 489 11 64; noemi.capdevila@upk.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: doubleblind regarding treatment no blinding regarding sleep manipulation
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head

Model Details: Within-Design regarding treatment (caffeine vs. placebo). Between-Design regarding sleep manipulation (sleep restriction vs. sleep manipulation)

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 30, 2023
• Study Start: March 31, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CH (1)