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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 is a Phase 2 study that has completed, run by Oregon Health and Science University. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04932096
The ClinicalTrials.gov registry entry for NCT04932096 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT04932096 reports 0 study locations.
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.
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