How Advanced Crohn's Disease Treatments Affect Sleep Quality
Tracks sleep with a wearable device in adults starting Crohn disease treatment.
Plain-language title generated from the registry record
Registry title: Impact of Advanced Crohn's Disease Therapies on Sleep Quality
Key facts
- Where
- Tel Aviv, IsraelSee the site
Where in Israel
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical CenterTel Aviv, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shmuel Kivity, MD
- Trial code
- NCT07649408
- Record updated
- 16 June 2026
- Original description
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.Read full original descriptionShow less
Impact of Advanced Crohn's Disease Therapies on Sleep Quality
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.
Inclusion: 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: Use of sleep medication - such as benzodiazepines or cannabis; Recent abdominal surgery - previous 4 weeks; 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; 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.