Not_yet_recruitingNANCT07636408

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

Sponsor: University of Ottawa

Trial Details

ConditionInsomnia, Concussion Post Syndrome
InterventionCBT-pI; Sleep Hygiene
PhaseNA
StatusNot_yet_recruiting
Participants70
Est. Completion1 Apr 2027
Last Updated11 June 2026

Primary Outcome

Changes in insomnia symptoms

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. Adults 18 years and older 2. 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) 3. Having a Sleep Condition Indicator score suggestive of insomnia (SCI =/\< 15, adapted to enable the inclusion of insomnia symptoms over at least 1 month) 4. Meeting diagnostic criteria for insomnia disorder on the SCID 5. Having a smartphone, tablet or computer and willingness to install a sleep intervention application on it Exclusion Criteria: 1. Having undergone another CBT-I program within the past 6 months 2. Current diagnosis of bipolar disorder, psychotic disorder, or substance use disorder confirmed by the M.I.N.I. 3. 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) 4. Body mass index \> 45 5. Shift work or rotating shifts within 1 month of study entry 6. Recent travel to a different time zone (leaving 1 week of recovery per time zone difference) 7. Any clinically significant neurological disorder aside from concussion (including seizure disorder) 8. Signs of sleep apnea as reflected by combined profiles on the Sleep Disorders Symptoms Checklist-25 and Epworth Sleepiness Scale 9. Unstable psychotropic medications (need to be on a stable dose for at least 1 month prior to study start) 10. Insufficient English skills to provide informed consent, understand study instructions, or fill out questionnaires

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