Down Syndrome Research Study
Researchers at Cincinnati Children’s Hospital Medical Center are conducting a study on oxygen therapy as a potential treatment for obstructive sleep apnea in children and teens with Down syndrome.
Fast Facts
Child With Down Syndrome Experiencing Sleep Apnea
5-17 Years Old
Compensation
Provided
Conducted Nationwide in the U.S.
Study Background
This study is exploring whether oxygen therapy during sleep can improve health and well-being for children with Down syndrome who have obstructive sleep apnea.
Obstructive sleep apnea (OSA) is common among children with Down syndrome and can affect sleep quality, brain function, and heart health. Current treatment options, like CPAP machines, are often difficult for children to tolerate. That’s why researchers are studying whether using oxygen during sleep could provide a safe and effective alternative.
Over the course of seven months, children who join the study will take part in both daytime visits and overnight sleep studies. During this time, researchers will monitor heart function, brain and behavioral health, sleep quality, and overall well-being. By comparing oxygen therapy to standard supportive care, this study aims to learn whether oxygen can improve sleep and daily life for children with Down syndrome.
Study Background
This study is exploring whether oxygen therapy during sleep can improve health and well-being for children with Down syndrome who have obstructive sleep apnea.
Obstructive sleep apnea (OSA) is common among children with Down syndrome and can affect sleep quality, brain function, and heart health. Current treatment options, like CPAP machines, are often difficult for children to tolerate. That’s why researchers are studying whether using oxygen during sleep could provide a safe and effective alternative.
Over the course of seven months, children who join the study will take part in both daytime visits and overnight sleep studies. During this time, researchers will monitor heart function, brain and behavioral health, sleep quality, and overall well-being. By comparing oxygen therapy to standard supportive care, this study aims to learn whether oxygen can improve sleep and daily life for children with Down syndrome.
Additional Information
This study is being done to learn if using oxygen while sleeping can improve sleep, brain function, heart health, and quality of life in children with Down syndrome who have obstructive sleep apnea.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Ages 5-17
- With down syndrome
- Experiencing symptoms of sleep apnea (e.g., loud snoring, pauses in breathing during sleep, excessive daytime sleepiness)
Exclusion Criteria:
- Chronic daytime or nighttime use of supplemental oxygen
- Unrepaired congenital heart disease
- Clinically significant untreated hypothyroidism
- Moderate to severe pulmonary hypertension requiring treatment with oxygen and/or pulmonary vasodilator
- Smoker in the house
You and your child will first complete a phone screening.
If eligible, your child will attend 3 daytime visits (2–4 hours each) and 2–3 overnight sleep studies over about 7 months.
Your child may be randomly placed in one of two groups:
Oxygen therapy group – receives an oxygen machine, nasal strips, sleep tips, and diet/weight management information.
Supportive care group – receives nasal strips, sleep tips, and diet/weight management information.
During visits, researchers will check heart health (ultrasound), sleep, behavior, and activity using simple tests and monitoring tools. Parents will also complete questionnaires and monthly check-ins with the study team.
Families can earn up to $735 for completing all parts of the study. Snacks are also provided during study visits. Travel reimbursement is provided.
There is no cost for you to participate in our research study.