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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT03992651
Eligibility Criteria:
Inclusion Criteria:
* Males or females between 18 and 50 year old
* Individual having health insurance
* Individual able to provided informed consent
* Subjects with no known pathology and not taking any medical treatment a priori capable of interfering with controlled hypoxia at levels required in the protocol
Exclusion Criteria:
* Body mass index \>27 kg/m²
* History of acute mountain sickness
* Chronic diseases know to be associated with high methemoglobinemia
* Known allergy to one of the materials used in the devices (lycra, polyamide...), or to the adhesive plaster.
* Active smoker (\>3 cigarets/day)
* Alcohol consumption (\>10g/day)
* Individual with high skin sensitivity due to skin diseases
* Mental disorders
* Persons who refuse to sign the information sheet and participation agreement
* Persons under guardianship or not subject to a social security system
* Pregnant woman, parturient, breastfeeding mother
* Person deprived of liberty by judicial or administrative decision
* A person who is subject to a legal protection measure that cannot be included in clinical trials.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03992651
Study Brief:
Protocol Section:
NCT03992651