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Sleep therapy may ease lingering concussion symptoms

NCT ID NCT07636408

Symptom relief Sponsor: University of Ottawa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether an online sleep improvement program can help people with ongoing concussion symptoms. 70 adults with insomnia after a concussion will use a digital platform for 8 weeks. The goal is to see if better sleep reduces symptoms and improves brain and heart function.

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 70 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Apr 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: 1. Adults 18 years and older 2. Experiencing persisting post-concussion symptoms \> 4 weeks but no more than 12 months post-injury as measured based on home-made screening questions and the Sport Concussion Assessment Tool (SCAT6) 3. Having a Sleep Condition Indicator score suggestive of insomnia (SCI =/\< 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month) 4. Meeting diagnostic criteria for insomnia disorder on the SCID 5. Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it Exclusion Criteria: 1. Having undergone another CBT-I program within the past 6 months 2. Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I. 3. Self-reported substance use disorder (i.e., alcohol, cannabis, or illicit drugs) or =/\> monthly use of illicit drugs reported on item-2 of the WHO-ASSIST (except tobacco, alcohol, and cannabis) 4. Body mass index \> 45 5. Shift work or rotating shifts within 1 month of study entry 6. Recent travel to a different time zone (leaving 1 week of recovery per time zone difference) 7. Any clinically significant neurological disorder aside from concussion (including seizure disorder) 8. Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale 9. Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start) 10. Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires

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Conditions

The condition(s) this trial relates to.

insomnia Post-Concussion Syndrome traumatic encephalopathy

As listed by the trial registrant

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

Concussion post syndrome Insomnia

How to take part

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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