Effects of Caffeine on Sleep-wake Regulation in Teenagers

March 25, 2020 updated by: Carolin Reichert

Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence - a Randomised, Placebo-controlled, Double-blind Clinical Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Basel, Switzerland
        • Centre for Chronobiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo capsule (mannitol)
Experimental: Caffeine
caffeine capsule (80 mg of caffeine plus mannitol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Nighttime sleep recordings start around 4 hours after caffeine/placebo intake
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.
Start of measurements around 45 minutes once after placebo, once after caffeine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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)
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.
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)
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).
Per condition around 480 minutes after bedtime
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)
Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment)
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
Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment)
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)
Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after 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.
Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes)
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.
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)
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.
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 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.
once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of caffeine levels and its metabolites
Time Frame: 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)
Levels of caffeine and its metabolites are measured in sweat and saliva. Higher values represent higher levels.
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)
Expectancy Questions
Time Frame: After each laboratory part (around 810 minutes after treatment)
Questions regarding the participant's guess in which condition (caffeine vs placebo) they assume to have taken part (categorical: correct [1] vs incorrect [0]), how sure they are (scores range from 1-10, higher scores indicate higher certainty) and open question on reasons/indications for guess.
After each laboratory part (around 810 minutes after treatment)
Craving for caffeine
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)
Craving for caffeine is measured using a visual analogue scale. Scores range from 0-100. Higher scores inidicate higher craving.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carolin Reichert, Centre for Chronobiology, Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2018

Primary Completion (Actual)

December 15, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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