RecruitingNAINTERVENTIONAL

Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.

This study is investigating a possible link between sleep problems and 'flares' in people with Inflammatory Bowel Disease (IBD), which includes conditions like Crohn's disease and ulcerative colitis. IBD often has periods when symptoms are well-controlled (remission) and times when they worsen (flares). Pinpointing when a flare might happen is very important for managing IBD. We believe that sleep issues, which are closely connected to our immune system and gut health, could be an early sign that a flare is coming. The main goal is to show that people's sleep quality tends to get worse before their IBD symptoms return. For one year, we will check on people who are currently in remission, monitoring both their IBD symptoms and their sleep patterns.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

216

Start

08 Apr 2025

Estimated completion

08 Jun 2028

Disease Bowel Crohn Disease Ulcerative Colitis

What is this study about?

If you have Inflammatory Bowel Disease (IBD), you know that your condition can have ups and downs. Sometimes your symptoms are well-controlled, and you're feeling good – this is called remission. Other times, your symptoms might get worse, which is known as a flare-up. Predicting these flare-ups and identifying people who are at a higher risk, even when they feel well, is a big challenge for doctors and for you.

This study explores an interesting idea: could your sleep patterns give us clues about upcoming IBD flares? We know that sleep, your immune system, and inflammation in your gut are all connected. So, it's possible that problems with sleep might show up before your IBD symptoms get worse. Researchers want to see if they can prove that sleep quality tends to decrease just before an IBD flare occurs.

To do this, we'll be looking at people with IBD who are currently in remission. For a year, we'll be keeping a close eye on their IBD symptoms and how well they're sleeping. This information could help us understand flares better and potentially find new ways to manage IBD in the future.

Key takeaways

This study investigates if sleep changes predict IBD flares.
It focuses on people with IBD who are currently in remission.
Participation involves monitoring IBD symptoms and sleep for one year.
No new medications are given as part of the study.
Findings could improve how IBD flares are predicted and managed.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 65 years old. You should have been diagnosed with Inflammatory Bowel Disease (IBD) for at least three months, and crucially, your IBD must currently be in remission. This means your symptoms have been well-controlled for at least three months, confirmed by both what you feel and certain blood or stool tests.

There are also some reasons why you might not be able to join. For instance, if you've recently had IBD complications like blockages or abscesses, or if you've had a lot of your bowel removed. People with an ostomy (bag for waste) or those already diagnosed with a sleep disorder cannot take part. Additionally, individuals who are pregnant, breastfeeding, in prison, or under certain legal or psychiatric care would not be eligible. This is to ensure the study is safe and fair for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you been diagnosed with IBD for at least 3 months?
Has your IBD been in remission (well-controlled) for at least 3 months?
Do you not have an ostomy (ileostomy or colostomy)?
Have you not been diagnosed with a sleep disorder?
Are you currently not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, your involvement would last for one year. Throughout this time, researchers will be regularly checking your IBD symptoms using simple scores and looking at blood or stool samples to measure inflammation. A key part of the study involves monitoring your sleep. You'll wear a small device, possibly like a watch, that tracks your activity (actigraphy). You'll also use a special headband (DREEM®) and fill out some questionnaires to help us understand your sleep patterns in detail. No specific medications will be given as part of the study; it focuses on symptom and sleep observation.

Potential risks and benefits

Taking part in this study may not directly benefit you, but it could help us understand IBD better and potentially lead to improved care for others in the future. The main 'risk' is the time commitment for assessments and wearing sleep-tracking devices. You might also find some of the questionnaires personal. However, all your information will be kept private and confidential. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

CHU Clermont-Ferrand, Hôpital d'Estaing
Verified postcode
Clermont-Ferrand, France· Not yet recruiting
CHU Grenoble Hôpital Michallon-Site Nord
Verified postcode
Grenoble, France· Not yet recruiting
Lyon Sud hospital
Verified postcode
Pierre-Bénite, France· Recruiting
CHU Saint Etienne
Verified postcode
Saint-Etienne, France· Not yet recruiting

Common questions

What is an IBD 'flare'?

An IBD 'flare' is when your Inflammatory Bowel Disease symptoms, like stomach pain or diarrhoea, suddenly get worse after a period of feeling well.

What does 'remission' mean for IBD?

Remission means your IBD symptoms are well-controlled, and tests show there's no active inflammation in your body. You're feeling good.

Will I have to take new medication?

No, this study does not involve taking any new or experimental medications. It's about observing your sleep and IBD symptoms.

How will my sleep be measured?

Your sleep will be measured using a small wearable device (like a smartwatch) and a headband you wear while sleeping, plus some questionnaires about your sleep habits.

How long will I be in the study?

Your involvement in this study will last for a period of one year.

How to find out more

Gilles Boschetti, MD,PhD

gilles.boschetti@chu-lyon.fr +33 4 78 86 13 02 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.