Study for Youth with Down Syndrome
Researchers at the University of Arizona are testing a treatment for sleep apnea in children with Down syndrome.
An Institutional Review Board responsible for human subjects research at The University of Arizona reviewed this research project and found it to be acceptable, according to applicable state and federal regulations and University policies designed to protect the rights and welfare of participants in research.
Fast Facts
Child Diagnosed with Down Syndrome
Child Ages 6-17
Compensation and Travel Reimbursement Provided
Recruiting Nationwide Conducted in Tucson, AZ
Study Background
Researchers at the University of Arizona are testing a combination of atomoxetine and oxybutynin as a treatment for sleep apnea in children with Down syndrome.
Atomoxetine is a medication approved by the FDA in children for the treatment of ADHD, while oxybutynin is approved by the FDA in children for treatment of overactive bladder. However, our preliminary research indicates that a combination of these medications can be used to treat obstructive sleep apnea in children with Down syndrome. This is because they work to increase airway muscle strength, which is known to be lower in children with Down syndrome. Ultimately, we hope that improving sleep apnea will also help improve patients’ cognitive abilities as well as their overall quality of life.
In this study, we will have participants use these medications for a period of 6 months and evaluate their ability to improve sleep apnea over this time. Participants will attend in-person visits at the beginning and end of the treatment period, during which the child will have a sleep study and complete cognitive assessments, while the parent will fill out surveys.
Study Background
Researchers at the University of Arizona are testing a combination of atomoxetine and oxybutynin as a treatment for sleep apnea in children with Down syndrome.
Atomoxetine is a medication approved by the FDA in children for the treatment of ADHD, while oxybutynin is approved by the FDA in children for treatment of overactive bladder. However, our preliminary research indicates that a combination of these medications can be used to treat obstructive sleep apnea in children with Down syndrome. This is because they work to increase airway muscle strength, which is known to be lower in children with Down syndrome. Ultimately, we hope that improving sleep apnea will also help improve patients’ cognitive abilities as well as their overall quality of life.
In this study, we will have participants use these medications for a period of 6 months and evaluate their ability to improve sleep apnea over this time. Participants will attend in-person visits at the beginning and end of the treatment period, during which the child will have a sleep study and complete cognitive assessments, while the parent will fill out surveys.
Additional Information
Through this research, we aim to test a combination of the medications atomoxetine and oxybutynin as a treatment for obstructive sleep apnea in children with Down syndrome. We hope that by improving patients’ sleep apnea, we can ultimately improve their cognitive abilities and quality of life.
You and your child may qualify for this study if they meet the following criteria.
Inclusion Criteria for Your Child:
- Ages 6-17
- Diagnosed with Down syndrome
- Able to discontinue PAP therapy if applicable
- No seizure disorder, untreated hypothyroidism, untreated depression
- No history of liver disease
- Born at ≥ 32 weeks
Our study will involve 2 in-person overnight visits, conducted approximately 6 months apart. These will take place in Tucson, AZ at the University of Arizona, and will involve the child completing a sleep study as well as a brief cognitive assessment. The parent will also be asked to fill out surveys about the child. Additionally, there will be 8 safety monitoring phone calls over the course of the study, with each lasting a few minutes.
Participants will receive $140 per in-person visit, for a total of up to $280 over the course of the study. We will also provide reimbursement for travel expenses, although we are unable to arrange travel.
There is no cost for you to participate in our research study.
