Impact of Advanced Crohn's Disease Therapies on Sleep Quality

Condition(s) studied

Investigational drug(s) / intervention(s)

Wearable activity and sleep tracker: 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)

Study summary

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

Primary outcome measure(s)

• Improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI) — Week 8
  Proportion of patients achieving improved sleep quality according to the Pittsburgh Sleep Quality Index (PSQI). Improvement is defined as a decrease of ≥3 points from baseline PSQI global score. Scores range from 0 to 21, with higher scores indicating worse sleep quality and greater sleep disturbance.

Trial sites (1)

More Shmuel Kivity, MD trials in Israel

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