Using medications to improve cognition in children with Down syndrome and sleep apnea
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
This study is testing if a combination of two medications can help improve thinking skills in children with Down syndrome and sleep apnea.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT05933603 on ClinicalTrials.gov |
What this trial studies
This open-label study investigates the effects of a combination of atomoxetine and oxybutynin (ato-oxy) on cognition in children aged 6 to 17 years with Down syndrome and obstructive sleep apnea (OSA). Participants will receive the medication for six months, with dosing occurring approximately 30 minutes before bedtime. The study includes an initial screening to determine eligibility, followed by a polysomnography (PSG) night to establish baseline measures. The primary focus is to assess cognitive improvements associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 years with a confirmed diagnosis of Down syndrome and documented obstructive sleep apnea.
Not a fit: Patients with central sleep apnea, those currently using positive airway pressure therapy, or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance cognitive function in children with Down syndrome who suffer from obstructive sleep apnea.
How similar studies have performed: While there is limited data on this specific combination treatment, similar studies have shown potential benefits of addressing sleep apnea in children with cognitive impairments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. 2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism) Exclusion Criteria: 1. Presence of central sleep apnea on polysomnography (central AHI ≥ 5) 2. Currently using and adherent to positive airway pressure therapy (\>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 3. Monoamine oxidase inhibitor use 4. Urinary retention 5. Prematurity \< 32 weeks estimated gestational age 6. Seizure disorder 7. Untreated or inadequately treated hypothyroidism 8. Significant traumatic brain injury 9. Congenital heart disease and not cleared to participate by the patient's cardiologist 10. History of current, untreated depression 11. History of liver disease 12. 3+ or greater tonsillar hypertrophy 13. Positive urine pregnancy test 14. Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation \<90%) 15. Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5) 3. Absence of OSA defined as total AHI \<5 on baseline polysomnography
Where this trial is running
Tucson, Arizona
- University of Arizona — Tucson, Arizona, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.