Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790161
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2023-03-04
Brief Title:
Consequences of Caffeine Intake in Sleep Restricted Teenagers
Sponsor:
Psychiatric Hospital of the University of Basel
Organization:
Psychiatric Hospital of the University of Basel
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:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
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 95h 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 outundergo
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 95h 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 outundergo
saliva sampling
questionnaires reward task mood sleepiness expectancy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None