Trial Parameters
Brief Summary
The purpose of this study is to assess whether oxygen supplementation during sleep improves working memory and other clinical and patient-reported outcomes among children who have Down Syndrome (DS) with moderate to severe Obstructive Sleep Apnea (OSA).
Eligibility Criteria
Inclusion Criteria: 1. Ages 5.0 to 17.9 years at the time of screening 2. Children with OSA and obstructive apnea hypopnea index (OAHI) ≥5/hour. 3. Absence of clinically significant hypoxia defined as oxygen saturation \<88% for 5 minutes or episodic desaturation to 60% as these levels would otherwise identify children eligible to routinely receive oxygen. 4. Favorable response to oxygen therapy (allowing randomization) will be defined as follows: 1. Oxygen saturation nadir \>92% and 2. Decrease in obstructive index \< 5 / hour or by \> 50% from screening PSG 3. Reaching an optimum oxygen flow which is defined as the flow that achieves the lowest level of AHI with maximum CO2 level less than 65 mmHg observed for 5 consecutive minutes and or an increase in CO2 by less than 15 points above baseline. The above criteria are observed while the patient spends a minimal of 30 minutes in the supine position and at least one cycle of rapid eye movement (REM) sleep. 4. Oxygen flow required does