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NCT07636408
Post-Concussion Sleep and Brain-heart Functions
Conditions: Insomnia, Concussion Post Syndrome
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: University of Ottawa
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07636408). StuddyBuddy aggregates publicly available trial information.