Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a nurse or an app fix sleep after brain injury?

NCT ID NCT05402761

Symptom relief Sponsor: Taipei Medical University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a brief behavioral treatment for insomnia (BBTi) — guided by a nurse or through a mobile app — can improve sleep, mood, and thinking in people recovering from traumatic brain injury (TBI). About 93 participants with chronic TBI and insomnia will be assigned to nurse-guided BBTi, app-based BBTi, or a control group. The goal is to see if these non-drug approaches can help TBI survivors sleep better and feel better without medication.

What this could mean

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

Active substance
brief behavioral treatment for insomnia (BBTi) delivered by a nurse or via a mobile app
What this could lead to
If successful, this could provide an effective, non-drug treatment for insomnia in TBI survivors, improving sleep, mood, and thinking skills without medication.
What could go wrong
This is a relatively small, early-stage trial (93 participants) comparing two behavioral approaches. Results may not apply to all TBI patients, and the mobile version may prove less effective than in-person guidance.

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 93 people

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

Started

Aug 2022

Expected to finish

Dec 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

20 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * have received a diagnosis of TBI at least 3 months before enrollment (TBI in chronic stage), * yield an initial (i.e., rated in the emergency room) GCS score of 3-15 (mild to severe) and have GCS score of 15 when enrolling into the study, * report lying awake for ≥30 min a night for ≥3 nights per week for ≥3 months, * have post-TBI insomnia with a total score \> 7 on the Chinese version of the insomnia severity scale (CISI) at screening, * be able to communicate in Mandarin Chinese, and be able to complete cognitive tasks (having Rancho Los Amigos Levels of Cognitive Functioning scale score \> 9) Exclusion Criteria: * include premorbid diagnoses of seizure, * sleep disorders (e.g., sleep apnea, screened by using the STOP-Bang questionnaire with a score \> 3), * psychiatric diseases, * substance abuse, * alcoholism * Shift workers and women who are pregnant, breastfeeding, or in the menopausal transition

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Insomnia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic insomnia traumatic brain injury

As listed by the trial registrant

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

Insomnia Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. 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

    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

  • Skin Kong International Health Center

    RECRUITING

    Taipei, 111, Taiwan

  • Taipei Medical University

    RECRUITING

    Taipei, 110, Taiwan

More trials for these conditions

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