This research study is investigating how six months of oxygen treatment while sleeping affects individuals 5 to 17 years old with Down syndrome. The study will look at sleep, breathing, heart function, quality of life, and whether the treatment makes them feel better. The team also wants to see if the oxygen helps decrease the severity of participants' obstructive sleep apnea (OSA).
Who can participate in this study?
Children and teens 5 to 17 years old who are diagnosed with Down syndrome and who:
- Have been diagnosed with OSA
- Have not been successful with CPAP or unable to use it
Who cannot participate in this study?
Contact research team for additional eligibility requirements.
Where does this study take place?
- Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
- Children’s Hospital of Philadelphia, Philadelphia, PA
- Rainbow Babies and Children’s Hospital, Case Medical Center, Cleveland, OH
- University of Michigan, Ann Arbor Hospital, Ann Arbor, MI
- Children’s Hospital of Los Angeles, LA, CA
- East Virginia Medical Center, Norfolk, VA
- Seattle Children’s Hospital, Seattle, WA
What activities are involved in this study?
The research team is testing how oxygen therapy works. They will randomly assign participants into two groups. One group will receive oxygen therapy, and the other group will not. Both groups will receive a nasal strip to improve breathing and education about good sleep habits and about, healthy diet, and weight management. At the beginning of the study and again after
6 months, the team will make measurements of your child’s sleep, brain function, heart, and quality of life.
You will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.
What is the expected time commitment of this study?
This study includes 4 to 5 visits over 7 months.
What languages does this study support?
English and Spanish
Is compensation provided?
Yes
If you have any questions or are interested in joining the Oxygen Therapy in Children and Teens with Down Syndrome and Obstructive Sleep Apnea study, please visit the study website.