Impact of Advanced Crohn's Disease Therapies on Sleep Quality

ConditionCrohn Disease (CD)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShmuel Kivity, MD

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

Wearable activity and sleep tracker

Treatment groups

30 Participants

are divided into 1 treatment group

Sponsors and collaborators

Shmuel Kivity, MD

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution

Source ClinicalTrials.gov