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AI coaching may help ostomy patients sleep better

NCT ID NCT07805226

Symptom relief Sponsor: Koç University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests a four-week digital nursing program designed to improve sleep in adults living with a colostomy, ileostomy, or urostomy. The program includes modules on stoma care, sleep hygiene, relaxation, body image, and physical activity, supported by a chatbot. Researchers will compare sleep quality and quality of life between those who receive the program plus standard care and those who receive standard care alone. The goal is to see if this approach can ease the sleep disruptions that often come with having an ostomy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Artificial Intelligence-Supported Multimodal Nursing Intervention (AI-MNI), a four-week digital program with modules on stoma care, sleep hygiene, relaxation, body image, and physical activity, plus a rule-based chatbot
What this could lead to
If it works, this program could offer a practical, home-based way to improve sleep and quality of life for people living with an ostomy.
What could go wrong
This is a small early-stage trial with 42 participants, so results may not apply to everyone. The program relies on self-reported sleep measures and a consumer wrist device, which may not capture full sleep accuracy.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 42 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Aged 18 years or older * Living with a colostomy, ileostomy or urostomy for at least three months * Pittsburgh Sleep Quality Index global score greater than 5, indicating poor sleep quality * Owns a smartphone with internet access and is able to use the digital modules and the chatbot * Cognitively able to complete self-report questionnaires and to participate actively in the intervention * Literate and able to communicate in Turkish * Provides written informed consent Exclusion Criteria: * Clinically diagnosed and/or currently treated primary sleep disorder * Sensory, cognitive or communication impairment that would prevent compliance with study procedures * Regular use of hypnotics, sedatives, antidepressants or antipsychotics * Any clinical or social condition that would prevent regular participation in the intervention

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSTOMY Quality of life Sleep quality

How to take part

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  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.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Koc University Hospital

    Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

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