Consequences of Caffeine Intake in Sleep Restricted Teenagers

Psychiatric Hospital of the University of Basel

Status: Enrolling

Conditions: Caffeine; Insufficient Sleep

Treatments: Drug: Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT05790161

CaReTeens

Details and patient eligibility

About

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)

Enrollment: 54 estimated patients

Sex: All

Ages: 14 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 14 and ≤ 17
• Clinically healthy
• Signed consent form of participant and legal guardian

Exclusion criteria

• Inability to operate tasks or understand the study information
• Participation in other clinical trials <3 months prior to any possible study start date
• BMI P3 < BMI-PC < P97
• Any general health concerns or disorders (previous diagnosis of heart/cardiovascular/nephrological/endocrinological/diabetic/metabolic/chronobiologic/ psychiatric/neurological [particularly epilepsy and parasomnia] conditions) which may make participants vulnerable to potential negative effects of SR or caffeine or which may affect outcome measures
• Unavailability to complete the two study protocol weeks within a three-month period
• Trans meridian travel (>2 time zones) <1 month before any possible study start date
• Shift work <3 months prior to any possible study start date
• Extreme chronotype MSFSC < 3:00 / MSFSC > 6:00 according to MCTQ
• Subjective sleep duration on school days <7h or >9h according to MCTQ
• Metallic prosthesis, metallic implants, or non-removable objects in the body (e.g., splinters, piercings) which affect MRI safety
• Tattoos with larger diameter than 10cm or above shoulder area, affecting MRI safety
• Claustrophobia
• Difficulties or problems in physical well-being and mental health based on the Swiss norm (T< 35) for all genders aged 12-18 according to KIDSCREEN-27
• Daily nicotine use
• Use of medications or drugs that have contraindications and/or effects on outcome measures or use of specific drugs indicated in drug test
• Use of alcohol to an extent that it is likely to have contraindications and/or effects on outcome measures
• Any indication of previous withdrawal or oversensitivity to caffeine
• Sleep quality >5 according to PSQI
• Problems of EEG compatibility
• Sleep efficiency <70%
• Identification of sleep disorders
• Pregnancy
• Deviation from the stabilisation sleep-wake schedule by +-60 mins
• Deviation from protocol sleep-wake schedule by +-30 mins

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

54 participants in 2 patient groups

Sleep Restriction

Experimental group

Description:

3 nights with 6h sleep opportunity each.

Treatment:

Drug: Caffeine

Sleep Extension

Experimental group

Description:

3 nights with 9,5h sleep opportunity each.

Treatment:

Drug: Caffeine