Effects of Caffeine on Sleep-wake Regulation in Teenagers

Caffeine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321785
• Other study ID #: 2017-02118
• Status: Completed
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: March 2020
• Source: Psychiatric Hospital of the University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 15, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescence
• Caffeine

Intervention

Other:
• Placebo
placebo capsule (mannitol)
• Caffeine
caffeine capsule (80 mg of caffeine plus mannitol)

Locations

Country	Name	City	State
Switzerland	Centre for Chronobiology	Basel

Sponsors (4)

Lead Sponsor	Collaborator
Carolin Reichert	Pontificia Universidad Catolica de Chile, Swiss National Science Foundation, University of Liege

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Course of caffeine levels and its metabolites	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)
Other	Expectancy Questions	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)
Other	Craving for caffeine	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)
Primary	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
Primary	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	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).	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)
Secondary	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.	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)
Secondary	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).	Per condition around 480 minutes after bedtime
Secondary	Change in working memory performance after caffeine intake (vs. placebo)	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)
Secondary	Change in viglance performance after caffeine intake (vs. placebo)	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)
Secondary	Change in declarative memory performance after caffeine intake (vs. placebo)	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)
Secondary	Change in pattern separation performance after caffeine intake (vs. placebo)	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)
Secondary	Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)	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)
Secondary	Change in well-being after caffeine intake (vs. placebo)	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)
Secondary	Change in cerebral blood flow	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)