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NCT04932096 · ClinicalTrials.gov registry record · Phase 2
Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin
A Phase 2 study, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT04932096: Completed Phase 2 study, sponsored by Oregon Health and Science University.
NCT04932096 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04932096, a Phase 2 study, has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Sleep Disturbances Scale for Children (SDSC): 26-item parent proxy sleep questionnaire with higher scores reflecting greater disturbance and risk for clinically important sleep disorders. Each question is scored 1 through 5 for a range of possible total scores of 26 - 130. Raw scores are converted to measure defined T-scores (mean=50, SD=10) for the total score and 6 subscale scores with higher scores indicating worse dysfunction, and T-scores greater than 60 generally indicating clinically sign
Interventions
- OTHER placebo
- DRUG melatonin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2023-01-02 |
| Est. Completion | 2025-03-01 |
| Phase | Phase 2 |
What the finished NCT04932096 record still lists
NCT04932096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT04932096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04932096 about?
NCT04932096 is a clinical study titled "Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin". 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 ...
What is the current status of trial NCT04932096?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2023-01-02. Estimated completion is 2025-03-01.
What interventions are being tested in trial NCT04932096?
The interventions under investigation include: placebo (OTHER), melatonin (DRUG).
Who is sponsoring clinical trial NCT04932096?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04932096's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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