Status:
NOT_YET_RECRUITING
Circadian Rhythm Deregulation in Patients With CAPS
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Cryopyrin Associated Periodic Syndrome
Familial Cold Urticaria
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within ea...
Eligibility Criteria
Inclusion
- --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)
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06544018
Start Date
September 1 2025
End Date
November 1 2028
Last Update
June 25 2025
Active Locations (6)
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1
Hôpital Femme-Mère-Enfant (HCL)
Bron, France, 69677
2
Hôpital Claude Huriez (CHU de Lille)
Lille, France, 59037
3
Hôpital de la Croix-Rousse (HCL)
Lyon, France, 69004
4
Hôpital Edouard Herriot (HCL)
Lyon, France, 69437