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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
21
Oregon Health & Science University
Portland, Oregon, United States
Sleep Disturbances Scale for Children
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.
Time frame: 1-month
Recruitment
Quantitative number of patients consented per patients approached
Time frame: through study completion, an average of 6-months
Retention
Quantitative number of participants completing trial procedures per patients consented
Time frame: through study completion, an average of 30 days
Adherence Quantitative
pill counts, report of using study medication at least 5/7 days per week
Time frame: 1-month
Adherence Qualitative
participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention
Time frame: 1-month
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale
Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS); 18 item parent proxy report of fatigue using a likert scale. Responses to each question receive a score of 0, 25,50,75, or 100. The measure provides a total score and three subscale scores- General, Sleep/rest, and Cognitive fatigue subscales based on the average response to each question for the total score and the average response to each subscale's questions for the subscale scores. All scores (total and subscale) range 0-100 with higher scores indicating better function and less fatigue.
Time frame: 1-month
Chronotype
Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness)
Time frame: 1-month
Sleep Latency
actigraphy measured time in minutes to fall asleep
Time frame: 1-month
Total Sleep Time
actigraphy measured total time asleep in minutes
Time frame: 1-month
Wake After Sleep Onset
actigraphy measured time in minutes awake after sleep onset
Time frame: 1-month
Number of Night Awakenings
actigraphy measured number of instances awoken after sleep onset
Time frame: 1-month
Sleep Efficiency
actigraphy measure percentage of nighttime period spent asleep
Time frame: 1-month
Sleep Onset Time
time of day fell asleep presented as hours corresponding the the time of day from midnight as 0 hours (e.g., 22.5 hours means they fell asleep at 10:30 pm)
Time frame: 1-month
Sleep Offset Time
time of day waking from nighttime sleep presented in hours from midnight as time 0 (e.g., 7.5 hours means they woke up at 7:30 am)
Time frame: 1-month
Adverse Events Time 0
Evaluation of adverse events asking participants to report any side effects of study interventions; Number of patients with any adverse event reported or noted on symptom screening checklist
Time frame: hospital discharge assessed up to 7 days
Adverse Events Time 1
Evaluation of adverse events asking participants to report any side effects of study interventions
Time frame: 1-month
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