Effects of Caffeine on Sleep-wake Regulation in Teenagers

Overview

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

Full Title of Study: “Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence – a Randomised, Placebo-controlled, Double-blind Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 15, 2018

Interventions

  • Other: Placebo
    • placebo capsule (mannitol)
  • Other: Caffeine
    • caffeine capsule (80 mg of caffeine plus mannitol)

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Caffeine

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • Change in hormonal profile after caffeine intake (vs. placebo)
    • Time Frame: 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)
    • Hormonal levels are measured in saliva samples. We focus on time of melatonin onset (higher values indicate later time).
  • Change in subjective sleepiness after caffeine intake (vs. placebo)
    • Time Frame: 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)
    • Sleepiness is measured by a questionnaire (Karolinska Sleepiness Scale, KSS). Higher scores on KSS (range between 1 and 9) represent higher sleepiness.
  • Change in subjective sleep quality after caffeine intake (vs. placebo)
    • Time Frame: Per condition around 480 minutes after bedtime
    • Subjective sleep quality is measured by the Leeds Sleep Evaluation Questionnaire (LSEQ). Four different scales are evaluated: a) Getting to Sleep (range: 1-100, where lower values represent more difficulties to fall asleep), b) Quality of Sleep (range: 1-100, where lower values represent lower quality), c) Awake Following Sleep (range: 1-100, where lower values represent problems to wake up), and d) Behavior Following Wakening (range: 1-100, where lower values represent more sleepiness after awakening).
  • Change in working memory performance after caffeine intake (vs. placebo)
    • Time Frame: Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment)
    • Working performance is measured by accuracy in an n-back task (%of correct responses in 2-back versus 0-back)
  • Change in viglance performance after caffeine intake (vs. placebo)
    • Time Frame: Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment)
    • Vigilance performance is measured by reaction time patterns in a psychomotor vigilance task
  • Change in declarative memory performance after caffeine intake (vs. placebo)
    • Time Frame: Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after treatment)
    • Performance is quantified by assessing the course of the number of words recalled from a list of words (learned before treatment)
  • Change in pattern separation performance after caffeine intake (vs. placebo)
    • Time Frame: Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes)
    • Cognitive performance is measured by the lure discrimination index and the recognition performance for repeat items.
  • Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)
    • Time Frame: Mental effort is measured 3 times in each condition (around 70 minutes, 200 minutes and 800 minutes after treatment)
    • Mental effort is measured by visual analogue scales targeting satisfaction, concentration, exhaustion and motivation. Scores range from 0-100. Higehr scores indicate higher levels on these scales.
  • Change in well-being after caffeine intake (vs. placebo)
    • Time Frame: 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)
    • Well-being is quantified as mean of three visual analogue scales targeting tension, mood and physical comfort. Scores range from 0-100. Higher scores indicate better well-being.
  • Change in cerebral blood flow
    • Time Frame: once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine)
    • Using magnetic resonance imaging (MRI), we measure levels of cerebral blood flow in the brain during rest.

Participating in This Clinical Trial

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)

Gender Eligibility: Male

Minimum Age: 14 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Carolin Reichert
  • Collaborator
    • Swiss National Science Foundation
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Carolin Reichert, Principal Investigator – Psychiatric Hospital of the University of Basel
  • Overall Official(s)
    • Carolin Reichert, Principal Investigator, Centre for Chronobiology, Basel

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