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Fitbit tracks sleep to reveal hidden benefits of Crohn's treatments

NCT ID NCT07649408

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, Israel

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