Could a VR AI agent beat a chatbot for treating insomnia?

NCT ID NCT07699042

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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 Results may not be published yet.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
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Status unknown
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First seen Jul 13, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study compares two ways of delivering digital cognitive behavioral therapy for insomnia (dCBT-I): one uses a standard app with an AI chatbot, the other uses a virtual reality (VR) environment with an embodied AI agent. Adults with insomnia are randomly assigned to one of the two groups and complete the therapy program. The goal is to see if the VR-enhanced version leads to better sleep outcomes and higher treatment adherence.

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 (dCBT-I) delivered via virtual reality with an embodied AI agent
What this could lead to
If it works, this could offer a more engaging and effective digital therapy for insomnia, potentially improving sleep without medication.
What could go wrong
This is a relatively small trial comparing two digital approaches, so results may not apply to everyone. The VR component may cause discomfort or be less accessible for some users.

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.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

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 65 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: * Adults of Chinese ethnicity, aged between 18 and 65 years. * Presence of insomnia, as indicated by a score of 10 or higher on the ISI. * Meeting the DSM-IV-TR diagnostic criteria for insomnia disorder. The 1-month duration criterion in DSM-IV-TR rather than the 3-month criterion in DSM-V is adopted to broaden the clinical relevance of the study findings. * Willing to provide online informed consent to participate in the study. * Willing to comply with the requirements outlined in the study protocol. * Possession of a smartphone and consistent internet access for smartphone use. * Acceptance of the terms of service and privacy policies of the mobile apps used for intervention delivery. Exclusion Criteria: * A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome. * A current or history of mental retardation or neuropsychiatric disorders other than depression or anxiety or stress disorders (as they are considered treatment outcomes), including bipolar disorder, schizophrenia, and substance use disorder. * Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt. * Currently receiving long-term pharmacological treatment, including sleep-promoting agents. * Currently undergoing structured psychotherapy. * A current or history of significant visual, auditory, or balance impairment. * A current or history of epilepsy * Subject who is preparing for pregnancy or pregnant * A current or history of any voice, speech, language disorders and learning difficulties. * A current or history of severe health conditions (e.g., stroke, heart attack) * Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study.

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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

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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

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  3. A doctor treating you

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Contacts and locations

Locations

  • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories

    Hong Kong, Hong Kong

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