Childhood Adenotonsillectomy Trial

5.2.0 Overview of NP Study Design

5.2.1 Participants

• Female and male children, ages 5-9.99 years with documented obstructive sleep apnea syndrome (OSAS)
• 460 children are anticipated to be recruited from ENT and Sleep Clinics at the four participating clinical sites

5.2.2 Examiners

• The NP group agreed that the same room should not be used for the blood draw and the neuropsychological testing
• The NP group agreed that the same person who does the blood draw should not do the neuropsychological testing

5.2.3 NP-associated exclusion criteria

• Mental retardation (DAS-II General Conceptual Ability Composite = 55)
• Family unable to speak English adequately to understand informed consent and able to complete the standardized English language assessment forms
• This protocol also will establish written local protocol instructions, consistent with local IRB, on how/who will determine whether the child meets exclusion criteria based on the protocol statement (Protocol Section 5.3 Exclusion Criteria): ”Psychiatric or behavioral disorders requiring initiation of new medication, therapy, or other specific treatment during the 12 month trial period.”