A sleep-health program to help teens recover faster from concussion
Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial
This project tests whether a personalized, multidimensional sleep-health program helps adolescents (ages 10–19) recover faster from concussion and sleep better than standard guidance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 10 Years to 19 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT07082218 on ClinicalTrials.gov |
What this trial studies
This is a prospective randomized trial that delivers a targeted, prescriptive sleep-health intervention to adolescents within the first month after a concussion and compares outcomes to standard post-concussion sleep guidance. The intervention was developed from prior pilot work and addresses multiple sleep domains with personalized recommendations. Outcomes include time to symptom resolution, self-reported sleep quality and duration, objective sleep measured by actigraphy, and secondary measures of mental health and academic engagement. The goal is to determine whether improving sleep leads to faster and more complete concussion recovery.
Who should consider this trial
Good fit: Symptomatic adolescents aged 10–19 diagnosed with a concussion (PCSI score ≥9) and able to enroll within the first month after injury are the intended participants.
Not a fit: People with a prior history of treatment for sleep disorders, those outside the 10–19 age range, or individuals with more severe brain injuries are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, the program could shorten recovery time and improve sleep, mood, and school functioning for adolescents after concussion.
How similar studies have performed: This approach is relatively novel: small pilot data from the study team and a few limited studies suggest promise, but large randomized evidence is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be symptomatic at the time of enrollment (Post-Concussion Symptom Inventory \[PCSI\] score ≥9) * Diagnosed with a concussion by a healthcare provider using the American Congress of Rehabilitation Medicine diagnostic criteria * 10-19 years of age (aligned with World Health Organization definition of 'adolescent') Exclusion Criteria: * History of treatment for pre-concussion sleep-related disorders
Where this trial is running
Aurora, Colorado
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: David R Howell, PhD — University of Colorado Denver | Anschutz
- Study coordinator: David R Howell, PhD
- Email: David.Howell@CUAnschutz.edu
- Phone: 7207771502
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.