Post-Concussion Sleep and Brain-heart Functions (NCT07636408) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Concussion Sleep and Brain-heart Functions
70 participantsStarted 2026-06
Plain-language summary
This project is designed as a randomized controlled trial (RCT), with an active control group. Sleep and heart rate will be monitored at home for 1 week before and after the intervention. Questionnaires will be completed from home before, during and 8 weeks after the end of the Intervention. The Cognitive Behavioural Therapy for Insomnia, adapted for post-concussed individuals (CBT-pI) and control interventions, will be delivered on a digital online platform over an 8-week period. Participants in the control arm will be offered CBT-pI after the follow-up period. All intervention arms will be delivered as adjuncts to standard clinical care. All other treatments received during the intervention will be documented.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults 18 years and older
. 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)
. Having a Sleep Condition Indicator score suggestive of insomnia (SCI =/\< 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month)
. Meeting diagnostic criteria for insomnia disorder on the SCID
. Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on sleep problems after a concussion — given my specific symptoms, does my doctor think insomnia is a significant enough part of my recovery that joining a sleep-focused study would make sense for me?
2Since this trial isn't recruiting yet, how long might I realistically wait before I could even enroll, and is there anything I should be doing to manage my post-concussion sleep problems in the meantime?
3The trial is listed as 'Phase NA,' which often means it's not testing a new drug but rather studying a condition or intervention in a different way — can my doctor explain what kind of intervention or monitoring is actually involved so I understand what participation would require?
4Since the main thing being measured is changes in insomnia symptoms, would joining this study mean I might be delaying or replacing other proven treatments for my post-concussion syndrome, or could I pursue standard care at the same time?
5What does my doctor think about how my brain and heart function might be connected to my sleep after a concussion, given that the trial seems to be looking at both — and is that something already being tracked in my current care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in insomnia symptoms
Timeframe: From baseline (week 0) to post-intervention (week 10)
. Having undergone another CBT-I program within the past 6 months
. Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I.
. 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)
. Body mass index \> 45
. Shift work or rotating shifts within 1 month of study entry
. Recent travel to a different time zone (leaving 1 week of recovery per time zone difference)
. Any clinically significant neurological disorder aside from concussion (including seizure disorder)
. Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale