Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

Description

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.

Conditions

Obstructive Sleep Apnea, Down Syndrome

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Study Overview

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Study Details

Study overview

This is an open-label study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with Down syndrome and obstructive sleep apnea (OSA) documented by polysomnography (PSG). Participants will receive ato-oxy for 6 months. Ato-oxy dose will be 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine. Dosing of the study treatment will occur approximately 30 minutes prior to bedtime. Participants who withdraw from the study will not be replaced. Study participants will undergo eligibility screening that will include an initial screening to determine whether non- PSG enrollment criteria are met, followed by a 1 night in-lab PSG and health-related quality of life (HRQOL) and cognitive assessment for participants who qualify based on non-PSG criteria. For participants who are eligible and enroll in the study, the screening PSG night will serve as the baseline measure for apnea hypopnea index (AHI) and other PSG endpoints. On the final night of dosing for ato-oxy participants will return for inpatient PSG and health-related quality of life assessment and cognitive assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline.

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona, Tucson, Arizona, United States, 86721

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Arizona,

Study Record Dates

2025-12