ClinicalTrials.gov record NCT06544018

Circadian Rhythm Deregulation in Patients With CAPS

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Identification of Circadian Rhythm Deregulation in Patients With Cryopyrin-associated Periodic Syndrome (CAPS)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age6 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study compares people with genetically confirmed CAPS and healthy household controls (age ≥6) to look for circadian rhythm changes. Participants wear a Withings Pulse HR actigraphic watch for 24 hours a day for one month, provide saliva and blood samples, and complete questionnaires; key measures are assessed up to 12 months. The study aims to identify circadian dysregulation in CAPS and investigate links between the circadian clock and NLRP3-related inflammatory pathways.

What it is studying. The study is testing whether people with CAPS (confirmed by NLRP3 genetic analysis) have differences in their circadian rhythms compared with healthy household controls. It measures timing and amount of melatonin secretion, daily activity patterns using a wearable actigraphic watch, chronotype by questionnaire, and blood markers tied to the NLRP3 inflammasome and circadian-clock pathways.

What the researchers hope to learn. Identify circadian rhythm dysregulation in patients with genetically confirmed CAPS; characterize melatonin secretion timing and peak concentration; compare circadian-clock biomarkers and activity patterns between CAPS patients and controls; map circadian clock regulatory pathways linked to NLRP3 inflammasome signaling.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 each cell. At the molecular level, the circadian clock is based on a complex system of cell-autonomous transcription loops. These exert positive and negative feedback on themselves, generating cyclic transcriptional activity.

  • In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1/CLOCK1 transcriptional activity.. The BMAL1/CLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.)..
  • other secondary loops refine the function of the first.

Recent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA/NOMID syndrome. Interestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined. The aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • Saliva sampling
  • Blood sampling
Genetic
  • Genetic analysis of NLRP3
Device
  • Circadian rhythm measurement
Other
  • Questionnaire
  • AIDAI score

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion 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)

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Wear a Withings Pulse HR actigraph wrist device 24 hours a day for one month to record activity and sleep patterns; provide blood for NLRP3 genetic testing and for inflammatory and molecular analyses; give saliva samples for melatonin measurement; and complete questionnaires about chronotype. CAPS patients will also complete the AIDAI disease-activity score. Key study measurements are reported at 6 months and 12 months after inclusion.

How the study is structured. Open-label, non-randomized, parallel groups. Participants are placed in two groups (CAPS patients and healthy household controls). Both groups wear a Withings Pulse HR actigraphic watch continuously for one month, collect saliva for melatonin testing, give blood samples for inflammatory and molecular analyses, and complete questionnaires; some outcomes are evaluated at about 6 and 12 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cryopyrin Associated Periodic Syndrome; Familial Cold Urticaria; Muckle-Wells Syndrome; CINCA Syndrome. Does it apply to my diagnosis?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

This trial is also listed on this site under cryopyrin-associated periodic syndromes.

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 25, 2026
Primary completion
Feb 25, 2029 (estimated)
Study completion
Feb 25, 2029 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Feb 27, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Hospices Civils de Lyon

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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