Using melatonin to improve sleep in kids recovering from traumatic brain injury
Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
This study is testing if giving melatonin can help kids with sleep problems after a traumatic brain injury feel better as they recover.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT04932096 on ClinicalTrials.gov |
What this trial studies
This pilot intervention evaluates the effectiveness of melatonin in managing sleep disturbances in pediatric patients recovering from traumatic brain injury. The study involves a randomized controlled trial where participants will receive either melatonin or a placebo during their hospital stay and after discharge. The primary focus is to assess the feasibility, acceptability, and effectiveness of this intervention in reducing sleep wake disturbances, measured one month post-discharge. All participants will also receive sleep education to support their recovery.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 19 years who have experienced a traumatic brain injury and are admitted to Oregon Health & Science University Hospitals.
Not a fit: Patients with severe complications such as significant liver injury or those requiring dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall recovery in children who have suffered traumatic brain injuries.
How similar studies have performed: While there is limited research specifically on melatonin for pediatric traumatic brain injury, similar interventions have shown promise in managing sleep disturbances in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: * Children age ≥6 years and \<19 years * Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging * Admission to Oregon Health \& Science University Hospitals * Deemed likely to survive hospitalization by clinical care team * Able to tolerate enteral medications within 72 hours of admission * Child participant resides with parent or legal guardian Exclusion: * Lack stable means of communication with study team (phone, email, mailing address) * Abusive trauma suspected or confirmed * Dialysis * Extracorporeal support (e.g. ECMO) * Significant liver injury defined as \>2x normal levels for AST or ALT * Clinical team safety concerns with use of intervention * Pregnancy * Prisoners
Where this trial is running
Portland, Oregon
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Cydni Williams, MD — Oregon Health and Science University
- Study coordinator: Cydni N Williams, MD
- Email: willicyd@ohsu.edu
- Phone: 503-494-5522
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.