Consequences of Caffeine Intake in Sleep Restricted Teenagers

NCT05790161 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-05-25

No results posted yet for this study

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)

Conditions

  • Caffeine
  • Insufficient Sleep

Interventions

DRUG

Caffeine

2mg/kg, once before night 6 and once before the scan (either on week 1 or 2, alternating with placebo)

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER
  • University of Basel

    collaborator OTHER
  • University Hospital, Basel, Switzerland

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • University of Liege

    collaborator OTHER
  • Psychiatric Hospital of the University of Basel

    lead OTHER

Principal Investigators

  • Carolin Reichert, Dr. · University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05790161 on ClinicalTrials.gov