Phase 2
N=21
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
Traumatic Brain Injury · Critical Illness · Sleep
Bottom Line
View on ClinicalTrials.gov: NCT04932096 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Aug 2025
Primary outcome: Primary: Sleep Disturbances Scale for Children — 55; 69; 64; 73 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- melatonin (Drug); placebo (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Disturbances Scale for Children |
55; 69; 64; 73; 51; 58 | — |
| PRIMARY Recruitment |
21 | — |
| PRIMARY Retention |
18; 1; 2 | — |
| SECONDARY Adherence Quantitative |
8; 7 | — |
| SECONDARY Adherence Qualitative |
8; 7 | — |
| SECONDARY Pediatric Quality of Life Inventory Multidimensional Fatigue Scale |
63.9; 54.9; 70.8; 50; 70.8; 58.3 | — |
| SECONDARY Chronotype |
24.5; 25 | — |
| SECONDARY Sleep Latency |
4.6; 5.3 | — |
| SECONDARY Total Sleep Time |
471; 459 | — |
| SECONDARY Wake After Sleep Onset |
4.4; 4.2 | — |
| SECONDARY Number of Night Awakenings |
31.2; 30.5 | — |
| SECONDARY Sleep Efficiency |
88; 88 | — |
| SECONDARY Sleep Onset Time |
23.42; 22.77 | — |
| SECONDARY Sleep Offset Time |
8.28; 7.58 | — |
| SECONDARY Adverse Events Time 0 |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Adverse Events Time 1 |
— | — |
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.
Eligibility Criteria
Inclusion:
- Children age ≥6 years and 2x normal levels for AST or ALT
- Clinical team safety concerns with use of intervention
- Pregnancy
- Prisoners
Data sourced from ClinicalTrials.gov (NCT04932096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.