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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 17
Healthy Volunteers: f
View:

• Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit.

• Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

Locations
United States
Arizona
University of Arizona
RECRUITING
Tucson
Time Frame
Start Date: 2023-09-29
Estimated Completion Date: 2025-12
Participants
Target number of participants: 36
Treatments
Experimental: Ato-oxy
0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of Arizona

This content was sourced from clinicaltrials.gov