Post-Concussion Sleep and Brain-heart Functions
Starting soon · Not applicable · Has a placebo group
Conditions studied: Insomnia, Concussion Post Syndrome
In brief
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.
Key facts
- Study ID
- NCT07636408
- Run by
- University of Ottawa
- People needed
- 70
- Starts
- 2026-06-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start)
- Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires
Full record on ClinicalTrials.gov
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