Impact of Advanced Crohn's Therapies on Sleep Quality

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 observational study follows adults with Crohn's disease who are about to begin advanced therapy. Participants will wear a Fitbit to monitor sleep, keep a sleep diary, and complete a sleep quality questionnaire, with follow-up over 26 weeks to see how sleep relates to treatment response. The study aims to describe associations between disease improvement and changes in sleep patterns, rather than testing a specific intervention. Data on disease activity and treatment response will be collected to explore potential links with sleep quality. The research acknowledges the complex interplay between inflammation, sleep, and quality of life in IBD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with established diagnosis of Crohn's Disease
* Patients with active inflammation, defined as HBI score ≥ 5 and either CRP\>5 or stool calprotectin\>250 mcg/gr.
* Patients starting advanced treatment as part of routine medical care (Anti TNFs, vedolizumab, Ustekinumab, IL-23 inhibitors, Jak inhibitors or S1P inhibitors).

Exclusion Criteria:

* Inability to give informed consent and complete the study protocol.
* Pregnant or lactating women
* Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: questionnaires, wearing the watch while sleeping.
* Patients diagnosed with UC or indeterminate IBD.
* Other sleep disorders Obstructive sleep apnea overactive bladder insomnia shift work disorder restless leg syndrome Periodic limb movement of sleep Narcolepsy
* Use of sleep medication - such as benzodiazepines or cannabis.
* Recent abdominal surgery - previous 4 weeks.
* Severe systemic disease - CVD, Kidney, liver - as jugged by physician's discretion.
* Patients with ileostomy or short bowl syndrome.

Where it's running

• Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

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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.