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Can an AI chatbot cure your sleepless nights?

NCT ID NCT06593262

Symptom relief Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an app that provides cognitive behavioral therapy for insomnia, enhanced with an AI chatbot, can help young people (ages 18-25) sleep better. Half of the 168 participants will use the app with the chatbot, and the other half will use the same app without it. The goal is to see if the chatbot makes the therapy more effective for reducing insomnia symptoms.

What this could mean

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

Active substance
digital cognitive behavioral therapy for insomnia with AI chatbot
What this could lead to
If it works, this could provide an accessible, low-cost digital therapy for young people with insomnia.
What could go wrong
This is a relatively small trial (168 participants) and the AI chatbot may not improve outcomes over the standard app. Results may not apply to all ages or severe cases.

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 168 people

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

Started

Jul 2024

Expected to finish

Aug 2026

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 to 25 years

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: i. Youth aged 18 to 25 years (as defined by WHO and evidence on AI mental health chatbots only available for individuals aged 18 years and older) ii. Online informed consent of participation in the study should be provided iii. Willing to comply with the requirements of the study protocol iv. The presence of moderate to severe insomnia measured by a score of 15 or above on the Insomnia Severity Index (ISI) v. difficulties initiating, maintaining or nonrestorative sleep over a 1-month period vi. Having access to a smartphone and consistent internet access for their smartphone vii. Accepting the terms of service and privacy policies of the mobile apps used in the study for the delivery of the intervention Exclusion Criteria: i. A history of any sleep disorder(s) (other than insomnia disorder) such as narcolepsy, obstructive sleep apnea, and restless legs syndrome ii. A history of any mental retardation or neuropsychiatric disorder(s) (other than depression and anxiety disorders as they are the secondary outcomes) such as bipolar disorder, schizophrenia, and substance use disorder iii. Presence of serious suicidality as evidenced by ideation with a plan or an attempt iv. Receiving any pharmacological treatment (including sleep promoting agents) v. Receiving any structured psychotherapy vi. Having shiftwork and trans-meridian travel in the past 3 months and during 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.

Insomnia

Contacts and locations

Locations

  • Department of Psychiatry, the Chinese University of Hong Kong

    Hong Kong, Hong Kong

More trials for these conditions

Other studies related to the condition(s) this trial covers.