Effects of Caffeine on Sleep-wake Regulation in Teenagers

NCT04321785 | Completed

• 1 other identifier: 2017-02118
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adolescence; Caffeine

Outcome Measures

Primary Outcomes (2)

• Change of sleep after caffeine intake (vs. placebo)

  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)

  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 Outcomes (10)

• 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 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 subjective sleep quality after caffeine intake (vs. placebo)

  Per condition around 480 minutes after bedtime

• 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 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)

Other Outcomes (3)

• Course of caffeine levels and its metabolites

  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

  After each laboratory part (around 810 minutes after treatment)

• Craving for caffeine

  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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

Caffeine

EXPERIMENTAL

Other: Caffeine

Interventions

Placebo OTHER

placebo capsule (mannitol)

Placebo

Caffeine OTHER

caffeine capsule (80 mg of caffeine plus mannitol)

Caffeine

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Carolin Reichert: lead
• Swiss National Science Foundation: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• University of Liege: collaborator

Study Sites (1)

Centre for Chronobiology

Basel, Switzerland

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Carolin Reichert

  Centre for Chronobiology, Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 25, 2020
• Study Start: April 13, 2018
• Primary Completion: December 15, 2018
• Study Completion: December 15, 2018
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

CH (1)