AdolescenceNCT04321785
Effects of Caffeine on Sleep-wake Regulation in Teenagers
A study testing Caffeine in people with Adolescence and Caffeine, run by Carolin Reichert at 1 site in Switzerland.
Trial summary
The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescence, Caffeine
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Apr 2018to 15 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Self-reported habitual caffeine consumption: min. 80 mg per month until max 300 mg per week as estimated from mean caffeine content per serving of caffeine containing beverages and food
- Body-Mass-Index: 16.2-25.4
- Informed Consent as documented by signature of participant
- Informed Consent as documented by signature of legal representative
Who cannot join
- Previous enrollment into the current study
- Investigators' family members, employees or other dependent persons
- Left-handedness
- No normal current health as based on questionnaires, screenings of urine, and examination by the physician in charge
- Drug use: Volunteers must be drug-free for the entire duration of the study, with no history of drug or alcohol dependency.
- Participation in other clinical trials <3 months prior to study begin
Show all 14Show fewer
- Shift work <3 months prior to study begin
- Transmeridian travel (>2 time zones) <1 month prior to study begin
- Extreme Chronotype (Munich Chronotype Questionnaire [17], MCTQ <2 or >7)
- Short or long sleep duration: subjective sleep duration during schooldays not between 6-10 h (based on MCTQ)
- Inability to follow procedures
- Insufficient knowledge of project language (German)
- Circumstances endangering MRI safety
- Non-compliance with sleep/wake times during ambulatory part (deviation of more than ±1.5 hour from scheduled times)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence - a Randomised, Placebo-controlled, Double-blind Clinical Study
The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.
- Conditions
- Adolescence, Caffeine
- Being tested
- Placebo, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
placebo capsule (mannitol)
CaffeineOther
caffeine capsule (80 mg of caffeine plus mannitol)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Caffeine | Experimental | Not described Receives: Other: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sleep after caffeine intake (vs. placebo)
Structure and intensity of sleep is measured by polysomnography. We focus on changes in deep sleep.
Measured: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake
Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)
Using magnetic resonance imaging (MRI), we measure blood-oxygen-level-dependent activity in the brain during a working memory task. How higher blood-oxygen-level-dependent activity can be interpreted depends on behavioral performance.
Measured: Start of measurements around 45 minutes once after placebo, once after caffeine
Secondary outcomes (10)
Change in hormonal profile after caffeine intake (vs. placebo)
Hormonal levels are measured in saliva samples. We focus on time of melatonin onset (higher values indicate later time).
Measured: Per condition (caffeine and placebo) 8 saliva samples (taken around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in subjective sleepiness after caffeine intake (vs. placebo)
Sleepiness is measured by a questionnaire (Karolinska Sleepiness Scale, KSS). Higher scores on KSS (range between 1 and 9) represent higher sleepiness.
Measured: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in subjective sleep quality after caffeine intake (vs. placebo)
Subjective sleep quality is measured by the Leeds Sleep Evaluation Questionnaire (LSEQ). Four different scales are evaluated: a) Getting to Sleep (range: 1-100, where lower values represent more difficulties to fall asleep), b) Quality of Sleep (range: 1-100, where lower values represent lower quality), c) Awake Following Sleep (range: 1-100, where lower values represent problems to wake up), and d) Behavior Following Wakening (range: 1-100, where lower values represent more sleepiness after awakening).
Measured: Per condition around 480 minutes after bedtime
Change in working memory performance after caffeine intake (vs. placebo)
Working performance is measured by accuracy in an n-back task (%of correct responses in 2-back versus 0-back)
Measured: Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment)
Change in viglance performance after caffeine intake (vs. placebo)
Vigilance performance is measured by reaction time patterns in a psychomotor vigilance task
Measured: Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment)
Change in declarative memory performance after caffeine intake (vs. placebo)
Performance is quantified by assessing the course of the number of words recalled from a list of words (learned before treatment)
Measured: Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after treatment)
Change in pattern separation performance after caffeine intake (vs. placebo)
Cognitive performance is measured by the lure discrimination index and the recognition performance for repeat items.
Measured: Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes)
Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)
Mental effort is measured by visual analogue scales targeting satisfaction, concentration, exhaustion and motivation. Scores range from 0-100. Higehr scores indicate higher levels on these scales.
Measured: Mental effort is measured 3 times in each condition (around 70 minutes, 200 minutes and 800 minutes after treatment)
Change in well-being after caffeine intake (vs. placebo)
Well-being is quantified as mean of three visual analogue scales targeting tension, mood and physical comfort. Scores range from 0-100. Higher scores indicate better well-being.
Measured: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in cerebral blood flow
Using magnetic resonance imaging (MRI), we measure levels of cerebral blood flow in the brain during rest.
Measured: once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start13 Apr 2018
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolin Reichert
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Pontificia Universidad Catolica de Chile, University of Liege
- Responsible party
- Sponsor-investigator, Carolin Reichert, Psychiatric Hospital of the University of Basel
- Investigators
- Carolin Reichert, Principal investigator, Centre for Chronobiology, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321785
- Sponsor's protocol ID
- 2017-02118
- Other IDs
- 2017
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeine-induced Effects on Sleep, Cognitive Performance, and Underlying Cerebral Correlates During Adolescence - a Randomised, Placebo-controlled, Double-blind Clinical Study
- ClinicalTrials.gov ID
- NCT04321785
- Acronym / sponsor ID
- 2017-02118
- Conditions
- Adolescence, Caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Carolin ReichertUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Pontificia Universidad Catolica de Chile, University of Liege
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to quantify the effects of one dose of caffeine (compared to placebo) on sleep and wakefulness in adolescents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo |
| Caffeine | Experimental | Other: Caffeine |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Self-reported habitual caffeine consumption: min. 80 mg per month until max 300 mg per week as estimated from mean caffeine content per serving of caffeine containing beverages and food
- Body-Mass-Index: 16.2-25.4
- Informed Consent as documented by signature of participant
- Informed Consent as documented by signature of legal representative
Key exclusion criteria (14 listed)
- Previous enrollment into the current study
- Investigators' family members, employees or other dependent persons
- Left-handedness
- No normal current health as based on questionnaires, screenings of urine, and examination by the physician in charge
- Drug use: Volunteers must be drug-free for the entire duration of the study, with no history of drug or alcohol dependency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placeboplacebo capsule (mannitol) | Other | Placebo |
| Caffeinecaffeine capsule (80 mg of caffeine plus mannitol) | Other | Caffeine |
Primary outcome
Change of sleep after caffeine intake (vs. placebo)
Time frame: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake
Structure and intensity of sleep is measured by polysomnography. We focus on changes in deep sleep.
Change of brain blood-oxygen-level-dependent activity after caffeine intake (vs. placebo)
Time frame: Start of measurements around 45 minutes once after placebo, once after caffeine
Using magnetic resonance imaging (MRI), we measure blood-oxygen-level-dependent activity in the brain during a working memory task. How higher blood-oxygen-level-dependent activity can be interpreted depends on behavioral performance.
10 secondary outcomes
Change in hormonal profile after caffeine intake (vs. placebo)
Time frame: Per condition (caffeine and placebo) 8 saliva samples (taken around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in subjective sleepiness after caffeine intake (vs. placebo)
Time frame: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in subjective sleep quality after caffeine intake (vs. placebo)
Time frame: Per condition around 480 minutes after bedtime
Change in working memory performance after caffeine intake (vs. placebo)
Time frame: Performance is measured 3 times in each condition (around 45 minutes, 180 minutes and 780 minutes after treatment)
Change in viglance performance after caffeine intake (vs. placebo)
Time frame: Performance is measured 3 times in each condition (around 85 minutes, 200 minutes and 730 minutes after treatment)
Change in declarative memory performance after caffeine intake (vs. placebo)
Time frame: Performance is measured 3 times in each condition (around before 40 minutes before treatment and 210 and 760 minutes after treatment)
Change in pattern separation performance after caffeine intake (vs. placebo)
Time frame: Performance is measured 3 times in each condition (around 20 minutes before treatment and 220 minutes and 770 minutes)
Change in mental effort during cognitive performance (working memory) after caffeine intake (vs. placebo)
Time frame: Mental effort is measured 3 times in each condition (around 70 minutes, 200 minutes and 800 minutes after treatment)
Change in well-being after caffeine intake (vs. placebo)
Time frame: Per condition (caffeine and placebo) 8 times (around 250 minutes, 230 minutes, 165 minutes, 115 minutes, 65 minutes and 15 minutes before bedtime, and 490 minutes and 520 minutes after bedtime)
Change in cerebral blood flow
Time frame: once after placebo, once after caffeine (start of measurements around 60 minutes after treatment once after placebo, once after caffeine)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolin Reichert principal investigator
Centre for Chronobiology, Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Adolescence and Caffeine, run by Carolin Reichert at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of sleep after caffeine intake (vs. placebo) (time frame: Nighttime sleep recordings start around 4 hours after caffeine/placebo intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.