Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Status:
Not yet recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
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, 2-weeks, 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.