Clinical trial Recruiting at 1 site Interventional Ages 10 to 19

A sleep-health program to help teens recover faster from concussion

Official title: Multidimensional Sleep Health Intervention to Optimize Concussion Recovery: A Randomized Clinical Trial

Run by University of Colorado, Denver · NCT07082218 · Data updated 2026-11-12

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

Study typeInterventional
Ages10 Years to 19 Years
SexAll
Enrollment54 (estimated)
SponsorUniversity of Colorado, Denver
Academic / other
Locations1 site (Aurora, Colorado)
StatusRecruiting
StartedSeptember 10, 2025
Main results expectedMay 1, 2027
Study endsJune 15, 2027
Registry record updatedJune 18, 2026
Trial IDNCT07082218 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Colorado Denver
    Aurora, Colorado, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.