NCT04321785CompletedNot Applicable
Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence - a Randomised, Placebo-controlled, Double-blind Clinical Study
Carolin Reichert1 site in 1 country18 target enrollmentStarted: April 13, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)
Study Overview
Brief Summary
The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 14 Years to 17 Years (Child)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)
Time Frame: Start of measurements around 45 minutes once after placebo, once after caffeine
Using magnetic resonance imaging (MRI), we measure blood-oxygen-level-dependent activity in the brain during a working memory task. How higher blood-oxygen-level-dependent activity can be interpreted depends on behavioral performance.
Change of sleep after caffeine intake (vs. placebo)
Time Frame: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake
Structure and intensity of sleep is measured by polysomnography. We focus on changes in deep sleep.
Secondary Outcomes
- Change in hormonal profile after caffeine intake (vs. placebo)(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))
- Change in viglance performance after caffeine intake (vs. placebo)(Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment))
- Change in subjective sleepiness after caffeine intake (vs. placebo)(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))
- Change in pattern separation performance after caffeine intake (vs. placebo)(Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes))
- Change in working memory performance after caffeine intake (vs. placebo)(Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment))
- Change in subjective sleep quality after caffeine intake (vs. placebo)(Per condition around 480 minutes after bedtime)
- Change in cerebral blood flow(once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine))
- Change in declarative memory performance after caffeine intake (vs. placebo)(Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after treatment))
- Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)(Mental effort is measured 3 times in each condition (around 70 minutes, 200 minutes and 800 minutes after treatment))
- Change in well-being after caffeine intake (vs. placebo)(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))
Investigators
Carolin Reichert
Principal Investigator
Psychiatric Hospital of the University of Basel
Study Sites (1)
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