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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT06714435
Eligibility Criteria:
Inclusion Criteria:
* Non-excessive coffee drinker (\< 3 espressos / day)
* Non-smoker or weaned for 3 months and total consumption \< 10 packs/year
* With a BMI within \]18 - 25\[ kg/m².
* Benefiting from a Social Security plan or benefiting from one through a third party
* Giving free, informed and signed consent, after receiving clear and fair information about the study.
Non-inclusion Criteria:
* History of respiratory or ENT disease (asthma, chronic bronchitis, COPD, respiratory allergy, swallowing disorders, oropharyngeal malformation, obstructive or central sleep apnea-hypopnea syndrome, alveolar hypoventilation syndrome)
* Respiratory, cardiovascular, muscular, neurological or diabetic pathology or disorders
* Raynaud's disease/syndrome
* History of epilepsy or history of malaise suggestive of epilepsy
* Psychiatric history requiring hospitalization
* Liver failure
* Renal insufficiency
* History of acute mountain sickness (presence during or after a stay at altitude of symptoms of vertigo, headache, nausea/vomiting and incapacitating fatigue: Lake Louise score \> 0)
* History of migraines
* Taking medications that interfere with respiratory function or cardiovascular function, or psychotropic drugs ( anxiolytic, sedative, antidepressant, neuroleptic, muscle relaxant, etc.).
* Alcohol or drug dependence
* Anemia, sickle-cell anemia
* SpO2 \< 97% at rest in room air
* Currently participating in another clinical study
* Protected persons within the meaning of article L1121-5 to 8 (persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, pregnant or breast-feeding women, persons staying in a health or social establishment, adults under legal protection, and patients in emergency situations). - Women with childbearing capacity who do not have effective contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
* Incidental finding of acute mountain sickness (Lake Louise score \>0)
* Pregnant woman (incidental finding)
* Persistence of average sleep time \< 6h
* Non-reversible deterioration in volunteer's state of health within study period
* Electroencephalogram signal unusable
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
40 Years
Study:
NCT06714435
Study Brief:
Protocol Section:
NCT06714435