Plain-English translation of NCT06043440 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This is a 6-month study testing whether therapy during sleep can help children with Down syndrome who have obstructive sleep apnea (a condition where breathing stops repeatedly during sleep). Half of the children will receive through a mask or nasal device at night, while the other half will receive educational materials about healthy sleep habits. The study will measure whether therapy improves thinking skills, behavior, mood, heart health, and sleep quality.
Children with Down syndrome are much more likely to have obstructive sleep apnea, which can affect their brain development, behavior, and heart health. Doctors want to know if using at night during sleep can help these children feel and function better, especially when surgery or other treatments haven't worked or aren't an option.
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You'll visit the clinic several times over 6 months. At the start, your child will have a sleep study test to see how helps their breathing. Half of participants will receive to use at night through a nasal device; the other half will get healthy sleep habit materials, dietary guidance, and nasal strips. You'll complete a sleep diary, your child will wear a wrist activity monitor, and at 3 and 6 months you'll answer questions about your child's behavior, thinking skills, sleep quality, and daily functioning. Your child will also have heart ultrasound, blood work, and a repeat sleep study at the end to see if the treatment helped.
AI-generated summary from trial data · Jun 3, 2026 · Not medical advice
United States