NCT04932096

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge. Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.

Conditions

• Traumatic Brain Injury
• Critical Illness
• Sleep

Interventions

Type	Name	Description
DRUG	melatonin	melatonin supplementation
OTHER	placebo	microcrystalline cellulose filled capsule

Timeline

• Start date: 2023-01-02
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-06-18
• Last updated: 2025-08-20
• Results posted: 2025-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study