RecruitingNot Applicable

Impact of Advanced Crohn's Disease Therapies on Sleep Quality

Israel30 participantsStarted 2025-08-06

Plain-language summary

The goal of this observational study is to measure changes in sleep quality before and after starting treatment with advance therapy in adult with Crohn disease. The main question it aims to answer is: what is the association between response to therapy and sleeping patterns? Participants who are about to begin advanced treatment will be asked to wear a Fitbit device before end after treatment initiation to monitor sleep patterns and sleep quality, complete a sleep diary and a sleep quality questionnaire. The follow-up period will last 26 weeks, during which disease severity and response to treatment will be assessed.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Week 8

Trial details

NCT IDNCT07649408

SponsorShmuel Kivity, MD

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-10

View on ClinicalTrials.gov More Crohn Disease (CD) trials