Circadian rhythm changes in people with CAPS
Identification of Circadian Rhythm Deregulation in Patients With Cryopyrin-associated Periodic Syndrome (CAPS)
This project will test whether people with CAPS have altered circadian rhythms by measuring sleep timing, saliva melatonin, and NLRP3 genetics and comparing them to healthy household members.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 6 sites (Bron and 5 other locations) |
| Trial ID | NCT06544018 on ClinicalTrials.gov |
What this trial studies
This interventional protocol compares circadian biology in patients with CAPS (confirmed by NLRP3 genetic analysis) to healthy household controls. Participants aged 6 and older provide saliva samples for melatonin measurement, complete sleep and symptom questionnaires including the AIDAI score, and undergo circadian rhythm monitoring. Genetic analysis of NLRP3 will confirm diagnosis and permit exploration of links between genotype and circadian markers. Subjects with chronic medicated sleep disorders are excluded to reduce confounding.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 or older with genetically confirmed CAPS (NLRP3), weight ≥25 kg and consent, together with healthy household members of similar age and weight willing to undergo saliva sampling and genetic testing.
Not a fit: Patients with chronic sleep disorders requiring medication or those without an NLRP3 mutation are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, the work could reveal circadian disruption as a treatable feature of CAPS and suggest timing-based or anti-inflammasome strategies to reduce symptoms.
How similar studies have performed: Preclinical and clinical research links circadian regulation to NLRP3 inflammasome activity, but circadian profiling specifically in genetically confirmed CAPS patients is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bron and 5 other locations
- Hôpital Femme-Mère-Enfant (HCL) — Bron, France (Recruiting)
- Hôpital Claude Huriez (CHU de Lille) — Lille, France (Not_yet_recruiting)
- Hôpital de la Croix-Rousse (HCL) — Lyon, France (Not_yet_recruiting)
- Hôpital Edouard Herriot (HCL) — Lyon, France (Not_yet_recruiting)
- Hôpital Tenon (AP-HP) — Paris, France (Not_yet_recruiting)
- Hôpital Kremlin-Bicêtre (AP-HP) — Paris, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Alexandre Alexandre, PR
- Email: Alexandre.belot@chu-lyon.fr
- Phone: 04 27 85 61 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.