Brigham and Women's Hospital
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).
This will be a randomized, single-blind 6-month Phase-2 clinical trial that compares the impact of oxygen therapy during sleep on measures of cognition, behavior, quality of life, cardiac structure and function, and sleep in children with Down Syndrome(DS) with moderate to severe obstructive sleep apnea. The proposed study will involve participation of children and their caregivers. Children will be recruited from each site's sleep clinics and laboratories, Down syndrome clinics and otolaryngology clinics. Community recruitment will be coordinated with local Down Syndrome Associations. Child…
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…
Active nocturnal oxygen concentrator