Clinical trial NCT04321785: Effects of Caffeine on Sleep-wake Regulation in Teenagers
Official title: Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence - a Randomised, Placebo-controlled, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescence
Caffeine
Lead sponsor: Psychiatric Hospital of the University of Basel
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Pontificia Universidad Catolica de Chile
name: University of Liege
First posted: 2020-03-25
Enrollment: 18
Sex: MALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.


Eligibility criteria: Inclusion Criteria:

* Self-reported habitual caffeine consumption: min. 80 mg per month until max 300 mg per week as estimated from mean caffeine content per serving of caffeine containing beverages and food
* Body-Mass-Index: 16.2-25.4
* Informed Consent as documented by signature of participant
* Informed Consent as documented by signature of legal representative

Exclusion Criteria:

* Previous enrollment into the current study
* Investigators' family members, employees or other dependent persons
* Left-handedness
* No normal current health as based on questionnaires, screenings of urine, and examination by the physician in charge
* Drug use: Volunteers must be drug-free for the entire duration of the study, with no history of drug or alcohol dependency.
* Participation in other clinical trials \<3 months prior to study begin
* Shift work \<3 months prior to study begin
* Transmeridian travel (\>2 time zones) \<1 month prior to study begin
* Extreme Chronotype (Munich Chronotype Questionnaire \[17\], MCTQ \<2 or \>7)
* Short or long sleep duration: subjective sleep duration during schooldays not between 6-10 h (based on MCTQ)
* Inability to follow procedures
* Insufficient knowledge of project language (German)
* Circumstances endangering MRI safety
* Non-compliance with sleep/wake times during ambulatory part (deviation of more than ±1.5 hour from scheduled times)

Primary outcomes:
measure: Change of sleep after caffeine intake (vs. placebo)
timeFrame: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake
measure: Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)
timeFrame: Start of measurements around 45 minutes once after placebo, once after caffeine
Secondary outcomes:
measure: Change in hormonal profile after caffeine intake (vs. placebo)
timeFrame: Per condition (caffeine and placebo) 8 saliva samples (taken around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
measure: Change in subjective sleepiness after caffeine intake (vs. placebo)
timeFrame: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
measure: Change in subjective sleep quality after caffeine intake (vs. placebo)
timeFrame: Per condition around 480 minutes after bedtime
measure: Change in working memory performance after caffeine intake (vs. placebo)
timeFrame: Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment)
measure: Change in viglance performance after caffeine intake (vs. placebo)
timeFrame: Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment)
measure: Change in declarative memory performance after caffeine intake (vs. placebo)
timeFrame: Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after treatment)
measure: Change in pattern separation performance after caffeine intake (vs. placebo)
timeFrame: Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes)
measure: Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)
timeFrame: Mental effort is measured 3 times in each condition (around 70 minutes, 200 minutes and 800 minutes after treatment)
measure: Change in well-being after caffeine intake (vs. placebo)
timeFrame: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
measure: Change in cerebral blood flow
timeFrame: once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine)
Other outcomes:
measure: Course of caffeine levels and its metabolites
timeFrame: Per condition (caffeine and placebo) 8 samples (taken around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
measure: Expectancy Questions
timeFrame: After each laboratory part (around 810 minutes after treatment)
measure: Craving for caffeine
timeFrame: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Locations:
city: Basel
country: Switzerland
facility: Centre for Chronobiology
Study officials:
affiliation: Centre for Chronobiology, Basel
name: Carolin Reichert
role: PRINCIPAL_INVESTIGATOR
References: