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.

NCT06043440

Down Syndrome Obstructive Sleep Apnea

Recruiting
PHASE2Ages 5–18InterventionalTreatment
Brigham and Women's Hospital
~230 participants
Updated 2025-04-20 on ClinicalTrials.gov
What's tested:Oxygen

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Behavior Rating Inventory of Executive Function 2 (BRIEF2) working memory score
Measured over Baseline and 6 months
+1 more outcome measured
Down Syndrome
Obstructive Sleep Apnea
7 sites across 6 states
Ohio2
California1
Michigan1
Pennsylvania1
Virginia1
Washington1
  • Susan Redline · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
  • Raouf Amin · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

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  • 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.