Impact of Advanced Crohn's Disease Therapies on Sleep Quality
Recruiting · NCT07649408 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shmuel Kivity, MD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed.
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center - Tel Aviv, Israel