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Could your body clock affect rare inflammatory disease?

NCT ID NCT06544018

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether people with CAPS (a rare genetic inflammatory condition) have disrupted circadian rhythms—the body's natural day-night cycle. Researchers will measure melatonin levels and track activity with a watch in 30 participants (patients and healthy household members). The goal is to understand how the internal clock may influence CAPS symptoms, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could reveal how the body's internal clock influences CAPS symptoms, pointing toward new ways to manage the disease.
What could go wrong
This is a small observational study (30 participants) that measures biomarkers, not a treatment trial. It may not lead to direct therapies or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

---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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Claude Huriez (CHU de Lille)

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Hôpital Edouard Herriot (HCL)

    NOT_YET_RECRUITING

    Lyon, 69437, France

  • Hôpital Femme-Mère-Enfant (HCL)

    RECRUITING

    Bron, 69677, France

  • Hôpital Kremlin-Bicêtre (AP-HP)

    NOT_YET_RECRUITING

    Paris, 94270, France

  • Hôpital Tenon (AP-HP)

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Hôpital de la Croix-Rousse (HCL)

    NOT_YET_RECRUITING

    Lyon, 69004, France

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