Crohn'sRecruiting

Impact of Advanced Crohn's Disease Therapies on Sleep Quality

Observational · No treatment assigned · 1 site · Shmuel Kivity, MD

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 and older
Any sex

Some of the main requirements, copied from the record:

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).

There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 30 participants are expected to take part.
Start date: 2025-08-06.
Main results expected around 2027-10 (estimate from the record).
1 study site listed (1 marked recruiting) in Israel.

Main thing being measured

Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI) (Week 8)

In the researchers’ words

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?

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Crohn Disease (CD)
Lead sponsor	Shmuel Kivity, MD
Enrollment	30 (estimated)
Start date	2025-08-06
Primary completion (est.)	2027-10
First posted	2026-06-16
Last updated	2026-06-16
Official title	Impact of Advanced Crohn's Disease Therapies on Sleep Quality
ClinicalTrials.gov ID	NCT07649408

Interventions

Wearable activity and sleep tracker (Other)
Patients will be asked to wear the Fitbit inspire 3 on their non-dominant hand for consecutive 5 days, in three different time slots (before initiation of new treatment, at week 4 after initiation, and at week 8 after initiation)

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center	Tel Aviv	Israel	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.