Post-Concussion Sleep and Brain-heart Functions

Sponsor
University of Ottawa
Study ID
NCT07636408
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CBT-pI — BEHAVIORAL
    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.
  • Sleep Hygiene — BEHAVIORAL
    This condition will leverage a digital sleep hygiene program that will mirror the CBT-I intervention

Study Details

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 Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cognitive Behavioural Therapy for Insomnia
    Four bi-weekly sessions lasting about 30-45 minutes covering all core elements of CBT-I, with some adaptations tailored to better serve people with post-concussion symptoms. For instance, the app design will account for light, sound, and visual field motion sensitivity (e.g. light enlarged text fonts on dark background colors, amber filters, sound processing to lower high pitch tones, minimized scrolling, and slow screen transitions). Also, the traditional psychoeducation module will be supplemented with information about sleep changes following concussion, interactions between sleep and chronic pain, expected course of recovery, the benefits of improving sleep for memory, concentration and mood.
  • Placebo Comparator: Placebo
    A digital sleep hygiene program will mirror the CBT-I intervention. It will be delivered over the same number/length of bi-weekly sessions using the same digital infrastructure as the CBT-PI program. The content will consist of educational information regarding sleep stages, normal sleep architecture, and healthy sleep practices (e.g., reducing caffeine and alcohol, avoiding exercise and other physical activity just before bed, having a light snack before bed, and keeping the bedroom quiet, and at a comfortable temperature).

Primary Outcome Measure

Changes in insomnia symptoms [ Time Frame: From baseline (week 0) to post-intervention (week 10) ]

Central Contacts

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