Status:
COMPLETED
Effects of Caffeine on Sleep-wake Regulation in Teenagers
Lead Sponsor:
Carolin Reichert
Collaborating Sponsors:
Swiss National Science Foundation
Pontificia Universidad Catolica de Chile
Conditions:
Adolescence
Caffeine
Eligibility:
MALE
14-17 years
Phase:
NA
Brief Summary
The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04321785
Start Date
April 13 2018
End Date
December 15 2018
Last Update
March 26 2020
Active Locations (1)
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1
Centre for Chronobiology
Basel, Switzerland