Critical Illness, Sleep, Traumatic Brain Injury
Conditions
Keywords
pediatric, traumatic brain injury, melatonin, sleep, intervention
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.
Interventions
DRUGmelatonin
melatonin supplementation
OTHERplacebo
microcrystalline cellulose filled capsule
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Children age ≥6 years and \<19 years * Traumatic brain injury defined as disruption of the normal function of the brain resulting from blunt force injury with a severity defined as mild complicated, moderate, or severe by the Glasgow Coma Scale with the presence of intracranial injury on imaging * Admission to Oregon Health & Science University Hospitals * Deemed likely to survive hospitalization by clinical care team * Able to tolerate enteral medications within 72 hours of admission * Child participant resides with parent or legal guardian Exclusion: * Lack stable means of communication with study team (phone, email, mailing address) * Abusive trauma suspected or confirmed * Dialysis * Extracorporeal support (e.g. ECMO) * Significant liver injury defined as \>2x normal levels for AST or ALT * Clinical team safety concerns with use of intervention * Pregnancy * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbances Scale for Children | 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 | through study completion, an average of 30 days | Quantitative number of participants completing trial procedures per patients consented |
| Recruitment | through study completion, an average of 6-months | Quantitative number of patients consented per patients approached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Latency | 1-month | actigraphy measured time in minutes to fall asleep |
| Wake After Sleep Onset | 1-month | actigraphy measured time in minutes awake after sleep onset |
| Number of Night Awakenings | 1-month | actigraphy measured number of instances awoken after sleep onset |
| Sleep Efficiency | 1-month | actigraphy measure percentage of nighttime period spent asleep |
| Sleep Onset Time | 1-month | 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) |
| Sleep Offset Time | 1-month | 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) |
| Adverse Events Time 0 | hospital discharge assessed up to 7 days | 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 |
| Adverse Events Time 1 | 1-month | Evaluation of adverse events asking participants to report any side effects of study interventions |
| Adherence Quantitative | 1-month | pill counts, report of using study medication at least 5/7 days per week |
| Adherence Qualitative | 1-month | participant report of compliance with treatment regimen evaluated by survey question estimating percentage of study days compliant with intervention |
| Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | 1-month | 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. |
| Chronotype | 1-month | Children's Chronotype Questionnaire, parent reported survey of circadian rhythm characteristics. Morningness/Eveningness Scale Score summed from responses, range 10 (morningness) to 49 (eveningness) |
| Total Sleep Time | 1-month | actigraphy measured total time asleep in minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 1-month | Patient Reported Outcome Measurement Information System (PROMIS) anxiety short form T-score with higher scores indicating worse outcome. T-scores range from 0 - 100, with a mean of 50 and standard deviation of 10. |
| Depression | 1-month | Patient Reported Outcome Measurement Information System (PROMIS) depression short form T-score with higher scores indicating worse outcome. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. |
| PROMIS Pain Behavior | 1-month | Patient Reported Outcome Measurement Information System (PROMIS) pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes |
| Reason for Non-adherence | 1-month | qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan |
| Cognitive Functioning | 1-month | Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10. |
| Health Related Quality of Life | 1-month | Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life. |
| Physical Functioning | 1-month | Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup |
Countries
United States
Participant flow
Recruitment details
21 of 53 eligible and approached participants recruited between January 2, 2023 and March 1, 2025. All participants were recruited during hospitalization for traumatic brain injury.
Participants by arm
| Arm | Count |
|---|---|
| Melatonin (melatonin doses of 3mg or 5mg based on patient size given nightly 1 hour prior to bedtime every night for 30 days)
melatonin: melatonin supplementation | 10 |
| Placebo Placebo
placebo: microcrystalline cellulose filled capsule | 11 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Partial completion (did not complete primary outcome survey) | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Melatonin | Total | Placebo |
|---|---|---|---|
| Admission Glasgow Coma Scale Score Mild, score 13-15 | 7 Participants | 16 Participants | 9 Participants |
| Admission Glasgow Coma Scale Score Moderate, score 9-12 | 1 Participants | 1 Participants | 0 Participants |
| Admission Glasgow Coma Scale Score Severe, score 3-8 | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 10.3 years | 10.7 years | 12.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Inpatient Rehabilitation Discharge Disposition | 1 Participants | 1 Participants | 0 Participants |
| Intracranial injury on imaging present at admission | 8 Participants | 14 Participants | 6 Participants |
| Medicaid Insurance Status Medicaid | 6 Participants | 12 Participants | 6 Participants |
| Medicaid Insurance Status Private Insurance | 4 Participants | 9 Participants | 5 Participants |
| Other injuries (non-brain) present at admission | 3 Participants | 9 Participants | 6 Participants |
| Pre-injury medical condition present | 3 Participants | 5 Participants | 2 Participants |
| Pre-injury neurodevelopmental condition present | 3 Participants | 6 Participants | 3 Participants |
| Pre-injury psychological diagnosis present | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 7 Participants |
| Skull fracture present at admission | 9 Participants | 15 Participants | 6 Participants |
| Sleep Disturbances Scale for Children Arousal Subscale | 47 T-score | 47 T-score | 47 T-score |
| Sleep Disturbances Scale for Children Breathing Subscale | 51 T-score | 51 T-score | 51 T-score |
| Sleep Disturbances Scale for Children Hyperhidrosis Subscale | 45 T-score | 45 T-score | 45 T-score |
| Sleep Disturbances Scale for Children Initiation and Maintenance Subscale | 64 T-score | 66 T-score | 76 T-score |
| Sleep Disturbances Scale for Children Sleep Wake Transition Subscale | 62 T-score | 54 T-score | 50 T-score |
| Sleep Disturbances Scale for Children Somnolence Subscale | 50 T-score | 50 T-score | 50 T-score |
| Sleep Disturbances Scale for Children Total score | 60 T-score | 60 T-score | 63 T-score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 4 / 10 | 2 / 11 |
| serious Total, serious adverse events | 1 / 10 | 0 / 11 |
Outcome results
Primary
Recruitment
Quantitative number of patients consented per patients approached
Time frame: through study completion, an average of 6-months
Population: Number of eligible patients approached for consent
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Melatonin | Recruitment | 21 Participants |
Primary
Retention
Quantitative number of participants completing trial procedures per patients consented
Time frame: through study completion, an average of 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Melatonin | Retention | Completion of Sleep Disturbances Scale for Children Survey | 18 Participants |
| Melatonin | Retention | Completion of other procedures but not Sleep Disturbances Scale for Children survey | 1 Participants |
| Melatonin | Retention | Participant withdrawal from study | 2 Participants |
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Melatonin | Sleep Disturbances Scale for Children | Total T-score | 55 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Initiation and Maintenance T-score | 64 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Transition T-score | 50 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Somnolence T-score | 50 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Breathing T-score | 51 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Arousal T-score | 47 T-score |
| Melatonin | Sleep Disturbances Scale for Children | Hyperhidrosis T-Score | 45 T-score |
| Placebo | Sleep Disturbances Scale for Children | Hyperhidrosis T-Score | 45 T-score |
| Placebo | Sleep Disturbances Scale for Children | Total T-score | 69 T-score |
| Placebo | Sleep Disturbances Scale for Children | Arousal T-score | 58 T-score |
| Placebo | Sleep Disturbances Scale for Children | Initiation and Maintenance T-score | 73 T-score |
| Placebo | Sleep Disturbances Scale for Children | Breathing T-score | 58 T-score |
| Placebo | Sleep Disturbances Scale for Children | Transition T-score | 54 T-score |
| Placebo | Sleep Disturbances Scale for Children | Somnolence T-score | 62 T-score |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Melatonin | Adherence Qualitative | 8 Participants |
| Placebo | Adherence Qualitative | 7 Participants |
Secondary
Adherence Quantitative
pill counts, report of using study medication at least 5/7 days per week
Time frame: 1-month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Melatonin | Adherence Quantitative | 8 Participants |
| Placebo | Adherence Quantitative | 7 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Melatonin | Adverse Events Time 0 | EVD placement and hyponatremia, not study related | 1 Participants |
| Melatonin | Adverse Events Time 0 | headaches at discharge | 0 Participants |
| Melatonin | Adverse Events Time 0 | Nausea, vomiting at discharge | 0 Participants |
| Melatonin | Adverse Events Time 0 | None | 8 Participants |
| Melatonin | Adverse Events Time 0 | Readmission to hospital, not study related | 1 Participants |
| Placebo | Adverse Events Time 0 | None | 9 Participants |
| Placebo | Adverse Events Time 0 | Readmission to hospital, not study related | 0 Participants |
| Placebo | Adverse Events Time 0 | EVD placement and hyponatremia, not study related | 0 Participants |
| Placebo | Adverse Events Time 0 | Nausea, vomiting at discharge | 1 Participants |
| Placebo | Adverse Events Time 0 | headaches at discharge | 1 Participants |
Secondary
Adverse Events Time 1
Evaluation of adverse events asking participants to report any side effects of study interventions
Time frame: 1-month
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Chronotype | 24.5 score on a scale |
| Placebo | Chronotype | 25 score on a scale |
Secondary
Number of Night Awakenings
actigraphy measured number of instances awoken after sleep onset
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Number of Night Awakenings | 31.2 number of awakenings |
| Placebo | Number of Night Awakenings | 30.5 number of awakenings |
Secondary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Melatonin | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Total Score | 63.9 score on a scale |
| Melatonin | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | General Fatigue Subscale | 70.8 score on a scale |
| Melatonin | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Sleep/rest Fatigue Subscale | 70.8 score on a scale |
| Melatonin | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Cognitive Fatigue Subscale | 75 score on a scale |
| Placebo | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Cognitive Fatigue Subscale | 54.1 score on a scale |
| Placebo | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Total Score | 54.9 score on a scale |
| Placebo | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | Sleep/rest Fatigue Subscale | 58.3 score on a scale |
| Placebo | Pediatric Quality of Life Inventory Multidimensional Fatigue Scale | General Fatigue Subscale | 50 score on a scale |
Secondary
Sleep Efficiency
actigraphy measure percentage of nighttime period spent asleep
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Sleep Efficiency | 88 percentage of time in bed deemed asleep |
| Placebo | Sleep Efficiency | 88 percentage of time in bed deemed asleep |
Secondary
Sleep Latency
actigraphy measured time in minutes to fall asleep
Time frame: 1-month
Population: Actigraphy usable providing 5/7 days per week of data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Sleep Latency | 4.6 minutes |
| Placebo | Sleep Latency | 5.3 minutes |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Sleep Offset Time | 8.28 hours corresponding to time of day |
| Placebo | Sleep Offset Time | 7.58 hours corresponding to time of day |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Sleep Onset Time | 23.42 hours corresponding to time of day |
| Placebo | Sleep Onset Time | 22.77 hours corresponding to time of day |
Secondary
Total Sleep Time
actigraphy measured total time asleep in minutes
Time frame: 1-month
Population: Actigraphy usable data if 5/7 days per week
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Total Sleep Time | 471 minutes |
| Placebo | Total Sleep Time | 459 minutes |
Secondary
Wake After Sleep Onset
actigraphy measured time in minutes awake after sleep onset
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Wake After Sleep Onset | 4.4 minutes |
| Placebo | Wake After Sleep Onset | 4.2 minutes |
Other Pre-specified
Anxiety
Patient Reported Outcome Measurement Information System (PROMIS) anxiety short form T-score with higher scores indicating worse outcome. T-scores range from 0 - 100, with a mean of 50 and standard deviation of 10.
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Anxiety | 38 T-score on a scale |
| Placebo | Anxiety | 50 T-score on a scale |
Other Pre-specified
Cognitive Functioning
Behavior Rating Inventory of Executive Function, second edition (BRIEF-2); parent proxy report of everyday executive function, reported as standardized Global Executive Composite T-score, with higher scores indicating worse function. T-scores range from 0-100, with a mean of 50 and standard deviation of 10.
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Cognitive Functioning | 52 T-score on a scale |
| Placebo | Cognitive Functioning | 55 T-score on a scale |
Other Pre-specified
Depression
Patient Reported Outcome Measurement Information System (PROMIS) depression short form T-score with higher scores indicating worse outcome. T-scores range from 0-100, with a mean of 50 and standard deviation of 10.
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Depression | 45 T-score on a scale |
| Placebo | Depression | 47 T-score on a scale |
Other Pre-specified
Health Related Quality of Life
Pediatric Quality of Life Inventory (PedsQL): parent reported measure of quality of life. Scores range 0-100 with higher scores indicating better quality of life.
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Health Related Quality of Life | 71.7 score on a scale |
| Placebo | Health Related Quality of Life | 59.8 score on a scale |
Other Pre-specified
Physical Functioning
Functional Status Scale, range 6-30, with higher scores indicating worse function; measured at followup
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | Physical Functioning | 6 score on a scale |
| Placebo | Physical Functioning | 6 score on a scale |
Other Pre-specified
PROMIS Pain Behavior
Patient Reported Outcome Measurement Information System (PROMIS) pain behavior (T-score with mean of 50 and standard deviation of 10) parent report forms; Higher scores indicate worse pain outcomes
Time frame: 1-month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Melatonin | PROMIS Pain Behavior | 47 T-score on a scale |
| Placebo | PROMIS Pain Behavior | 10 T-score on a scale |
Other Pre-specified
Reason for Non-adherence
qualitative response to survey question about reasons for non-compliance with treatment regimen or sleep plan
Time frame: 1-month
Population: Reasons given for not using study medication every night or sleep plan resources at any frequency
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Melatonin | Reason for Non-adherence | Patient wanted to stop medication | 0 Participants |
| Melatonin | Reason for Non-adherence | Fell asleep before taking medication | 1 Participants |
| Melatonin | Reason for Non-adherence | Pharmacy issues | 0 Participants |
| Melatonin | Reason for Non-adherence | forgot about sleep education | 2 Participants |
| Melatonin | Reason for Non-adherence | Transitioning between parent houses or moving | 1 Participants |
| Melatonin | Reason for Non-adherence | Did not see sleep education in paperwork | 2 Participants |
| Melatonin | Reason for Non-adherence | Misplaced medication | 1 Participants |
| Placebo | Reason for Non-adherence | Did not see sleep education in paperwork | 2 Participants |
| Placebo | Reason for Non-adherence | Misplaced medication | 0 Participants |
| Placebo | Reason for Non-adherence | Pharmacy issues | 1 Participants |
| Placebo | Reason for Non-adherence | Patient wanted to stop medication | 1 Participants |
| Placebo | Reason for Non-adherence | Transitioning between parent houses or moving | 1 Participants |
| Placebo | Reason for Non-adherence | Fell asleep before taking medication | 1 Participants |
| Placebo | Reason for Non-adherence | forgot about sleep education | 2 Participants |