Post-Concussion Sleep and Brain-heart Functions

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.

NCT Number	NCT07636408
Lead Sponsor	University of Ottawa
Conditions	Insomnia, Concussion Post Syndrome
Enrollment	70 participants
Start Date	2026-06
Primary Completion	2027-04 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-11