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:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT06544018
Eligibility Criteria:
---Inclusion Criteria:
Patient with CAPS group :
* Patients aged 6 and over
* Participant with CAPS confirmed by NLRP3 genetic analysis
* Weight greater than or equal to 25 Kg
* Parents/guardians who have been informed of the study and have signed a consent form.
* Patient affiliated to a social security scheme
Control group (healthy participant):
* Participant aged 6 and over
* Weight greater than or equal to 25 Kg
* Participant living in the same household as a subject with CAPS genetically confirmed by NLRP3 analysis and included in the protocol
* Participant with no CAPS (a priori) who consents to NLRP3 genetic analysis
* Parents/guardians who have been informed of the study and have signed a consent form.
* Participant who has been informed of the study and has agreed to take part
* Participant affiliated to a social security scheme
* Exclusion Criteria :
Patient with CAPS group :
* Patients with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin).
* Patients with sleep apnea syndrome
* Patients working regular night shifts or alternating day and night shifts
* Pregnant or breast-feeding women
* Parents with an infant under 6 months of age
* Patient participating in another interventional drug study
* Deprivation of civil rights (curators, guardianship, safeguard of justice)
Control group (healthy participant):
* Participants with a chronic illness (ALD beneficiaries)
* Participants with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin)
* Participants working regular night shifts or alternating day and night shifts
* Pregnant or breast-feeding women
* Parents with an infant under 6 months of age
* Participant participating in another interventional drug study
* Deprivation of civil rights (curators, guardianship, safeguard of justice)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT06544018
Study Brief:
Protocol Section:
NCT06544018