LuMind IDSC will serve as a key partner to researchers from the University of Arizona in an upcoming study of sleep apnea treatment for people with Down syndrome. As part of a $10.4 million award from the Patient-Centered Outcomes Research Institute (PCORI), LuMind will support the investigation by Dr. Daniel Combs and Dr. Sairam Parthasarathy to evaluate a precision medicine approach to assess the effectiveness of sleep apnea treatment in people with Down syndrome.
The multi-site clinical study will enroll 200 participants, including children (age 6–17) and adults with Down syndrome who have been diagnosed with obstructive sleep apnea (OSA). The research will take place at five sites in the United States.
OSA is common in people with Down syndrome and occurs when breathing is repeatedly interrupted during sleep. If left untreated, OSA can negatively affect behavior, cardiovascular health, and cognitive development.
This study will examine the use of atomoxetine and oxybutynin in combination (“ato-oxy”) as a treatment for OSA. Previous studies have shown that ato-oxy is effective for some, but not all, individuals with Down syndrome. Similarly, oxygen therapy can benefit certain people but does not work universally. To address this challenge, the trial will apply a precision medicine strategy: half of the participants will be randomly assigned to receive ato-oxy, while the others will be assigned to either oxygen or ato-oxy based on clinical factors that suggest which treatment is likely to work best for them.
Researchers will measure outcomes such as OSA severity, quality of life, behavior, and cognition at the start of the study and again after 12 months of treatment. Side effects will also be monitored closely to assess the safety of each approach.
The study is expected to begin enrolling participants in spring 2026.
This study was selected through PCORI’s highly competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals.
PCORI is a nonprofit organization with a mission to fund research designed to provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
