Table 1

Primary and secondary endpoints, prespecified candidate moderators

Primary endpointsBRIEF2/P Global Executive Composite Score12 13
GNG sustained attention d-prime parameter14
Secondary endpoints
Objective performance testingGNG inhibitory control d-prime14
Fine motor coordination: NIH-Toolbox 9-Hole Pegboard Dexterity Test
Behavioural scaleExecutive function: BRIEF 2/P meta-cognition and emotional regulation summary scores and subscales for parent and teacher reports
Behaviour: Child Behaviour Checklist23 summary scale and subscores, parent and teacher ratings
Attention: Conners 3 Short Form (caregiver and teacher versions) Global Index T score and subscales24
Sleep-disordered breathing symptomsPSQ-SRBD Scale total score25
Sleepiness: Epworth Sleepiness Scale modified for children summary score and PSQ-SRBD sleepiness scale26
Snoring: the patch snoring sensor
Quality of lifeGeneric: Paediatric Quality of Life Inventory total score and subscores27
Disease specific: Obstructive Sleep Apnea-18 (OSA-18) total score
Physical examMeasurements of weight; height; body mass index; waist, hip and neck circumferences
Systolic, diastolic and mean blood pressure levels
Healthcare useMedications, healthcare visits (scheduled and unscheduled), ascertained from caregiver reports, EMR surveillance, billing and pharmacy records and hospitalisations
Potential effect modifiers
DemographicsRace, SES (parent education, family income, financial stress rating scale and geocode data on neighbourhood characteristics)
Sleep duration and efficiencyObjective assessment by 7-day wrist actigraphy
Asthma/atopyIgE, International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire, review of EMR and parent interview (using NHLBI asthma definitions based on a history of asthma and use of asthma medications)
Secondhand smoke exposureUrinary cotinine
Family functioning clusterFamily functioning (Family Assessment Device, short form); parenting style (Parenting Style Questionnaire); parent perception of stress (Parenting Stress Index Fourth Edition, short form); medical literacy (Rapid Estimate of Adult Literacy in Medicine, Revised) and discrimination (Experiences of Discrimination)
  • BRIEF, Behavioural Rating Inventory of Executive Function; EMR, electronic medical record; GNG, Go-No-Go; NIH, National Institutes of Health; PSQ-SRBD, Paediatric Sleep Questionnaire: Sleep-Related Breathing Disorder.