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NOT YET RECRUITING
NCT07636408
NA

Post-Concussion Sleep and Brain-heart Functions

Sponsor: University of Ottawa

View on ClinicalTrials.gov

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.

Official title: Enhancing Sleep to Improve Brain-heart Functions in People With Persistent Post-concussion Symptoms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-06

Completion Date

2027-04

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

CBT-pI

A digital CBT-pI program co-developed with lived experts with a history of post-concussion insomnia and inspired from published recommendations and existing evidence-based CBT-pI programs.

BEHAVIORAL

Sleep Hygiene

This condition will leverage a digital sleep hygiene program that will mirror the CBT-I intervention