Post-Concussion Sleep and Brain-heart Functions

NCT07636408 | Not Yet Recruiting

• 1 other identifier: 373
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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

Insomnia; Concussion Post Syndrome

Keywords

Cognitive Behavioral Therapy for Insomnia; digital therapy

Outcome Measures

Primary Outcomes (1)

• Changes in insomnia symptoms

  Changes in insomnia symptoms as indicated by the Insomnia Severity Index-7 (ISI-7) total score from pre-intervention to post-intervention. The ISI-7 is a 7 item questionnaire with total scores ranging from 0 to 28, with higher scores indicating more severe insomnia symptoms.

  From baseline (week 0) to post-intervention (week 10)

Secondary Outcomes (28)

• Satisfaction with treatment effectiveness as measured with the Modified Treatment Satisfaction Questionnaire for Medication

  10 weeks

• Satisfaction with treatment effectiveness as measured by the Modified Treatment Satisfaction Scale

  10 weeks

• Changes in insomnia symptoms

  From baseline (week 0) to the first follow-up (week 14)

• Changes in insomnia symptoms

  From baseline (week 0) to the last follow-up (week 34)

• Treatment acceptability as measured by the Treatment Acceptability/Adherence Scale

  10 weeks

Study Arms (2)

Cognitive Behavioural Therapy for Insomnia

ACTIVE COMPARATOR

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.

Behavioral: CBT-pI

Placebo

PLACEBO COMPARATOR

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).

Behavioral: Sleep Hygiene

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.

Cognitive Behavioural Therapy for Insomnia

Sleep Hygiene BEHAVIORAL

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

Sponsors & Collaborators

• University of Ottawa: lead

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Rebecca Robillard

  University of Ottawa Institute of Mental Health Research at The Royal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Robillard

CONTACT

613-722-6521; Rebecca.Robillard@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: June 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share