Consequences of Caffeine Intake in Sleep Restricted Teenagers

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. The main questions it aims to answer are: The effects of caffeine under conditions of SR and SE: - on sleep pressure and sleep continuity. - on BOLD activity differences in reward related areas during a reward task (monetary incentive delay task) and on reaction times (behavioral aspect) in the same task. - on BOLD activity differences during a risk taking task (wheel of fortune task) and on risky decision-making (behavioral aspect) in the same task. Participants will be either in the SR or SE condition (between-subject). The protocol consists of 2x of approximately one week in which a participant will receive caffeine or placebo (within-subject) at the last two evenings. The experiment consists of an ambulatory and a laboratory phase: - The ambulatory phase consists of 5 nights, including 3 stabilization nights (8h sleep opportunity) prior to 2 nights consisting of either SR with 6h sleep opportunity or SE with 9.5h sleep opportunity. Participants will wear an actiwatch and fill out sleep diaries during this period. - The laboratory phase will be the 6th evening, night and morning of the protocol and will be spent in our lab. Participants will do the following: - treatment (caffeine vs. placebo) intake - saliva sampling - drug screening - cognitive tests, including risk-taking and reward task - filling in questionnaires (sleep diary, sleep quality, sleepiness, mood, expectancy) - waking and sleep with EEG The next day, participants will undergo an fMRI scan, including the following: - resting-state scan - structural scan - arterial spin labeling scan - reward task scan - risk-taking task scan Around the scan, participants will fill out/undergo: - saliva sampling - questionnaires (reward task, mood, sleepiness, expectancy)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05790161
Study type	Interventional
Source	Psychiatric Hospital of the University of Basel
Contact	Carolin Reichert, Dr.
Phone	+41 77 488 42 45
Email	carolin.reichert@upk.ch
Status	Recruiting
Phase	N/A
Start date	March 31, 2023
Completion date	September 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.