Effects of Caffeine on Sleep-wake Regulation in Teenagers

Carolin Reichert18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Adolescence Caffeine

Interventions

PlaceboOTHER

placebo capsule (mannitol)

CaffeineOTHER

caffeine capsule (80 mg of caffeine plus mannitol)

Eligibility

Sex: MALEMin age: 14 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Centre for Chronobiology

Basel, Switzerland

Outcomes

Primary Outcomes

Change of sleep after caffeine intake (vs. placebo)

Structure and intensity of sleep is measured by polysomnography. We focus on changes in deep sleep.

Time frame: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake

Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)

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.

Time frame: Start of measurements around 45 minutes once after placebo, once after caffeine

Secondary Outcomes

Change in hormonal profile after caffeine intake (vs. placebo)

Hormonal levels are measured in saliva samples. We focus on time of melatonin onset (higher values indicate later time).

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)

Change in subjective sleepiness after caffeine intake (vs. placebo)

Sleepiness is measured by a questionnaire (Karolinska Sleepiness Scale, KSS). Higher scores on KSS (range between 1 and 9) represent higher sleepiness.

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)

Change in subjective sleep quality after caffeine intake (vs. placebo)

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).

Data from ClinicalTrials.gov

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