Oxygen for Obstructive Sleep Apnea in Children with Down Syndrome
This study is looking at whether giving oxygen during sleep can help children with Down Syndrome and moderate to severe Obstructive Sleep Apnea (OSA) improve their working memory and other important areas of their life. Researchers will compare the effects of an active nocturnal oxygen concentrator (a device that provides oxygen) over 6 months. You might be able to join if you are 5 to 17 years old, have Down Syndrome, and have OSA where your breathing stops or gets very shallow at least 5 times per hour during sleep. The study aims to see if oxygen improves working memory and other abilities, as measured by specific tests. The current status of this study is unclear.
- Study design
- This is a randomized, single-blind Phase 2 study planning to include 230 participants. It compares oxygen therapy during sleep to see its effects.
- What's involved
- You would participate for 6 months, with assessments at the beginning and end of this period. You would also undergo screening for eligibility.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed at 6 months after starting the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Down Syndrome Obstructive Sleep Apnea
At a glance
Conditions
Where it's being run
7 sites across 6 statesStudy leadership
- Susan Redline · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
- Raouf Amin · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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What this trial measures
- Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory scoreBaseline and 6 months
Change from baseline in the Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score (BRIEF2wm). The score ranges from 35-90. A higher score is a worse outcome.
- Differential Ability Scales - 2nd Edition (DAS-II) T-score.Baseline and 6 months
Change from baseline in the Differential Ability Scales - 2nd Edition (DAS-II) recognition of pictures (DAS2RoP) T-score. The score ranges from 10-90. A higher score is a better outcome.