NCT07649408Recruiting
Impact of Advanced Crohn's Disease Therapies on Sleep Quality
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 28 May 2026
- Start date
- 6 Aug 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Shmuel Kivity, MD
- Diseases
- Crohn's disease
- NCT number
- NCT07649408
What you commit to
- Study type: Observational
- Planned participants: 30
- From 6 Aug 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of sleep medication - such as benzodiazepines or cannabis.
- Recent abdominal surgery - previous 4 weeks.
Other illness
- Other sleep disorders Obstructive sleep apnea overactive bladder insomnia shift work disorder restless leg syndrome Periodic limb movement of sleep Narcolepsy
- Severe systemic disease - CVD, Kidney, liver - as jugged by physician's discretion.
- Patients with ileostomy or short bowl syndrome.
Other
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.