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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00997256
Eligibility Criteria:
Inclusion Criteria:
* Healthy male volunteers aged between 18 and 55 years
* Normal sleeping times (at least 6 hours a night), going to sleep between 22.00 and 1.00 hours, getting up between 6.00 and 9.00 hours
* Written informed consent
* The volunteer is willing and able to cooperate fully
* The volunteer agrees not to drink any alcohol for the duration of the study
Exclusion Criteria:
* Participation in another study in the last 30 days or participation in this study at an earlier date
* Lack of verbal or intellectual ability to communicate adequately and to understand the information to volunteers
* Legal incompetence
* Smoker
* Shift worker
* Transatlantic flight in the last 4 weeks
* Taking psychotropic drugs within the last 4 weeks
* Taking medicines that influence the EEG within the last 4 weeks
* Diseases that influence the sleep EEG
* History of known medication / drug / alcohol misuse according to ICD-10 coding F10 - F19
* Known intolerance/hypersensitivity/allergy to St. John's wort, valerian or passionflower
* Taking inadmissible concomitant medication (anxiolytic, neuroleptic or hypnotic drugs, cyclosporin, sedative, sleep-promoting or mood-enhancing medicines, antidepressants other than the trial medication, coumarin-type anticoagulants, oral contraceptives, tranquillisers, homeopathic remedies, digoxin, theophylline, indinavir, nortriptyline, amitriptyline)
* Known light-sensitivity
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00997256
Study Brief:
Protocol Section:
NCT00997256