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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01070004
Eligibility Criteria:
Inclusion Criteria:
* 20-25-year-old healthy Volunteers or of 40-50 years, male, Caucasian,
* Presenting no disorder of the perception,
* Taking no treatment interfering with the sleep, the attentiveness and the circadian system,
* BMI ≥18 et ≤ 27
* Moderate Drinker of coffee(café) (2-3 cups a day) •
* Presenting no medical history or evolutionary pathology,
* Not presenting syndrome of apneas / hypopnea during the sleep (IAH \< 5 for 20-25 years and 10 for 40-50 years),
* Not presenting syndrome of periodic movements during the sleep (Index of MPS \< 15),
* Not professional Driver, having their driving license for at least 3 years or 2 years for the drivers who followed the learning anticipated and driving between 10000 and 20000 km a year,
* Having looked in writing their consent to participate in the study,
* Having regular schedules of life 3 days before going into the study,
* Registers on the Social Security and on the register of the healthy volunteers.
Exclusion Criteria:
* Night workers,
* Any evolutionary psychiatric affections (psychosis, disorder(confusion) of the mood or the anxiety),
* All the sleeping disorders (sleep apneas, periodic leg movements, narcolepsy, phase delay, advance of phase),
* Any evolutionary neurological affections (brain tumour, epilepsy, Headache, brain vascular accident, calcifies, myoclonia , chorea, neuropathy, muscular dystrophies, myotonic dystrophy),
* Cardiovascular Pathologies (arterial high blood pressure, cardiac insufficiency, coronary disease, vascular disorders(confusions)),
* Lung Pathologies (BPCO, BPR),
* Renal Disorders(Confusions) (renal insufficiency, nephrolithiases),
* Endocrine Pathologies (dysthyroid, diabetes),
* Drug addiction, alcoholic dependence during the last 6 months,
* Having made a trans-meridian journey (± 3 hours) in last 3 months.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01070004
Study Brief:
Protocol Section:
NCT01070004