Impact of Advanced Crohn's Disease Therapies on Sleep Quality

NCT07649408 | Recruiting

• 2 other identifiers: 0167-25-TLVMOH_2025-06-19_014152
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease (CD)

Keywords

CD; Fitbit; Sleep qulity; Response to treatment

Outcome Measures

Primary Outcomes (1)

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

  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.

  Week 8

Secondary Outcomes (21)

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

  Week 4

• Change in sleep onset latency

  Week 4

• Change in sleep onset latency

  Week 8

• Change in wake after sleep onset (WASO)

  Week 4

• Change in wake after sleep onset (WASO)

  Week 8

Study Arms (1)

Crohn disease patients

Patients starting advanced treatment as part of routine medical care

Other: Wearable activity and sleep tracker

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)

Also known as: Fitbit inspire 3

Crohn disease patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CD patients receiving care at the IBD Clinic at Tel Aviv Sourasky Medical Center (TASMC)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shmuel Kivity, MD: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 26 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 16, 2026
• Study Start: August 6, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-05

Locations

IL (1)