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Children with PSG results that do not meet OAI/AHI saturation criteria after central review are ineligible for participation regardless of the local clinical interpretation of the PSG data. PSG exclusion criteria are:
Severe OSAS or significant hypoxemia requiring immediate AT as defined by:
OAI > 20 or
AHI > 30,
Desaturation defined as SaO2 <90% for more than 2% sleep time
Apnea hypopnea indices in the normal range (OAI < 1 and AHI < 2).
Evidence of clinically significant cardiac arrhythmia on PSG: