Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT05790161
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consequences of Caffeine Intake in Sleep Restricted Teenagers
Sponsor:
Psychiatric Hospital of the University of Basel
Organization:
Study Overview
Official Title:
Consequences of Caffeine Intake in Teenagers: Effects on Sleep, Reward Processing, Risk Taking, and Underlying Cerebral Mechanisms Under Conditions of Sleep Restriction
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: