Sleep Management And Recovery After Traumatic Brain Injury in Kids (SMARTKids): Evidence for Targeting Sleep to Improve Outcomes
Overview
- Phase
- Phase 2
- Intervention
- melatonin
- Conditions
- Traumatic Brain Injury
- Sponsor
- Oregon Health and Science University
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Sleep Disturbances Scale for Children
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Cydni Williams
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Melatonin
(melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
Intervention: melatonin
Placebo
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Sleep Disturbances Scale for Children
Time Frame: 1-month
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 significant dysfunction in the total score and all 6 subscale scores. The subscales include Initiation and Maintenance, Arousal, Breathing, Transition, Somnolence, and Hyperhidrosis.
Retention
Time Frame: through study completion, an average of 30 days
Quantitative number of participants completing trial procedures per patients consented
Recruitment
Time Frame: through study completion, an average of 6-months
Quantitative number of patients consented per patients approached
Secondary Outcomes
- Adherence Quantitative(1-month)
- Adherence Qualitative(1-month)
- Pediatric Quality of Life Inventory Multidimensional Fatigue Scale(1-month)
- Sleep Latency(1-month)
- Total Sleep Time(1-month)
- Chronotype(1-month)
- Wake After Sleep Onset(1-month)
- Number of Night Awakenings(1-month)
- Adverse Events Time 0(hospital discharge assessed up to 7 days)
- Adverse Events Time 1(1-month)
- Sleep Efficiency(1-month)
- Sleep Onset Time(1-month)
- Sleep Offset Time(1-month)