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Your sleep could warn of an IBD attack

NCT ID NCT05835973

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 216 adults with inflammatory bowel disease (IBD) who are in remission. They wear a wrist monitor and fill out sleep questionnaires for one year to see if changes in sleep quality can predict when a flare-up will happen. The goal is to find early warning signs of relapse.

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 sleep changes reliably predict IBD flares, doctors could monitor sleep to catch relapses early and adjust treatment sooner.
What could go wrong
This is an observational study, not a treatment trial. It may find no clear link between sleep and flares, or the results may not 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 216 people

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

Started

Apr 2025

Expected to finish

Jun 2028

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 over 18 and under 65 years of age. * Patient with Inflammatory Bowel Disease diagnosed for at least 3 months. * Patient in remission, for at least 3 months: 1. clinical remission: Harvey-Bradshaw score (HBI) \< 5 for CD and a Mayo score \< 3 for UC 2. and biological remission: absence of objective inflammation defined by CRP \< 5 mg/L and/or fecal calprotectin \< 250 µg/g. * Patient must sign informed consent form to participate to the study. * Patient affiliated to or benefiting from a social security plan. Exclusion Criteria: * Patient with complications (obstructive symptoms, fistulas or intra-abdominal abscesses in the previous three months). * Patient with extensive bowel resection (\> 40 cm of small bowel). * Patient with an ileostomy or colostomy. * Patient diagnosed with sleep disorders. * Patient without legal capacity to consent. * Pregnant, parturient or nursing women. * Persons deprived of liberty by judicial or administrative decision. * Persons under psychiatric care. * Persons admitted to a health or social institution for purposes other than research. * Persons of full age who are subject to a legal protection measure (guardianship, curators).

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease intestinal disorder Recurrence Sleep Deprivation ulcerative colitis

As listed by the trial registrant

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

Crohn disease Disease bowel Ulcerative colitis

How to take part

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

  1. The places running it

    4 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

  • CHU Clermont-Ferrand, Hôpital d'Estaing

    NOT_YET_RECRUITING

    Clermont-Ferrand, 63100, France

  • CHU Grenoble Hôpital Michallon-Site Nord

    NOT_YET_RECRUITING

    Grenoble, 38700, France

  • CHU Saint Etienne

    NOT_YET_RECRUITING

    Saint-Etienne, 42270, France

  • Lyon Sud hospital

    RECRUITING

    Pierre-Bénite, 69310, France

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