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Fitbit tracks sleep to reveal hidden benefits of Crohn's treatments
NCT ID NCT07649408
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study investigates whether advanced treatments for Crohn's disease also improve sleep quality. Adults with active Crohn's who are about to start a new advanced therapy will wear a Fitbit Inspire 3 for five days at three different times: before treatment, at week 4, and at week 8. They will also complete sleep diaries and questionnaires. The goal is to see if better disease control leads to better sleep, which could offer a simple way to monitor treatment success.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fitbit Inspire 3 wearable tracker
- What this could lead to
- If sleep improves with treatment, this could point toward using sleep tracking as a simple way to measure how well Crohn's therapy is working.
- What could go wrong
- This is a small, observational study with only 30 participants, so results may not apply to everyone. Sleep changes could be due to other factors, not just the treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
CD patients receiving care at the IBD Clinic at Tel Aviv Sourasky Medical Center (TASMC)
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
RECRUITINGTel Aviv, Israel
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Other studies related to the condition(s) this trial covers.
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