Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT05790161
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
17 Years
Study:
NCT05790161
Study Brief:
Protocol Section:
NCT05790161