Circadian rhythm changes in people with CAPS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

---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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.