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Post-Concussion Sleep and Brain-heart Functions

NCT07636408 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-06-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • University of Ottawa

    lead OTHER

Principal Investigators

  • Rebecca Robillard · University of Ottawa Institute of Mental Health Research at The Royal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-04-30
Completion
2027-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07636408 on ClinicalTrials.gov