Effects of Caffeine on Sleep-wake Regulation in Teenagers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2018-12-15

Brief Summary

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

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Detailed Description

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Conditions

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Adolescence Caffeine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo capsule (mannitol)

Caffeine

Group Type EXPERIMENTAL

Caffeine

Intervention Type OTHER

caffeine capsule (80 mg of caffeine plus mannitol)

Interventions

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Placebo

placebo capsule (mannitol)

Intervention Type OTHER

Caffeine

caffeine capsule (80 mg of caffeine plus mannitol)

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes