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Online sleep program could help TBI patients get better rest

NCT ID NCT05683145

Symptom relief Sponsor: VA Eastern Colorado Health Care System 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a guided online version of cognitive behavioral therapy for insomnia in 80 people who have had a moderate or severe traumatic brain injury at least a year ago and currently have insomnia. Participants will either receive the online therapy (6 modules over 6-9 weeks with support from a mental health professional) or continue with their usual care. The goal is to see if the online therapy improves sleep and quality of life, especially for those who may not have easy access to in-person treatment.

What this could mean

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

Active substance
guided online cognitive behavioral therapy for insomnia
What this could lead to
If it works, this could provide an accessible, effective treatment for insomnia in people with moderate/severe traumatic brain injury, improving recovery and quality of life.
What could go wrong
This is a relatively small early-stage study (80 participants) comparing the therapy to usual care, so results may not apply to everyone. The therapy requires internet access and self-motivation, which may limit its effectiveness for some.

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 80 people

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

Started

Jul 2022

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 60 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: * History of post-acute (i.e., at least one year after injury) moderate to severe traumatic brain injury * Current insomnia * Reliable access to the internet * Ability to provide informed consent Exclusion Criteria: * Active substance dependence, excluding cannabis * Current psychosis * Bipolar disorder * Current sleep disorders other than insomnia, including sleep apnea * Irregular work schedule, shift work, and/or life changes (e.g., newborn) interfering with regular sleep patterns. * Currently receiving psychological treatment for insomnia * Pregnancy * Currently involved in another research interventional trial targeting insomnia

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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

    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

    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

  • Rocky Mountain Regional VAMC

    RECRUITING

    Aurora, Colorado, 80045, United States

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