Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Wearable activity and sleep tracker

    Other intervention

    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)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Crohn disease patients1 intervention

Trial outcomes

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.

Time frame
Week 8

Secondary 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.

Time frame
Week 4
2

Change in sleep onset latency

Average change from baseline in sleep onset latency. Sleep onset latency is the length of time it takes to transition from full wakefulness to the lightest stage of sleep. Sleep onset latency will be calculated as the time interval between the bedtime reported by participants in the sleep diary and the time of sleep onset as determined from Fitbit data.

Time frame
Week 4
3

Change in sleep onset latency

Average change from baseline in sleep onset latency. Sleep onset latency is the length of time it takes to transition from full wakefulness to the lightest stage of sleep. Sleep onset latency will be calculated as the time interval between the bedtime reported by participants in the sleep diary and the time of sleep onset as determined from Fitbit data.

Time frame
Week 8
4

Change in wake after sleep onset (WASO)

Average change from baseline in wake after sleep onset. Wake after sleep onset will be calculated as the total time spent awake after sleep onset and before final awakening, as determined from Fitbit data. A low WASO indicates continuous, restorative sleep, whereas a high WASO points to sleep fragmentation.

Time frame
Week 4

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shmuel Kivity, MD

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution

Source ClinicalTrials.gov
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