Medications for Obstructive Sleep Apnea In Children With Down Syndrome

Evaluation of Atomoxetine and Oxybutynin for Obstructive Sleep Apnea in Children With Down Syndrome


Lead Sponsor: University of Arizona

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Source University of Arizona
Brief Summary

This is a randomized, double blind, cross-over study of the combination of atomoxetine and oxybutynin (ato-oxy) in children with DS and OSA documented by polysomnography (PSG). Participants will receive high dose ato-oxy for four weeks as well as low dose ato-oxy for four weeks in random order. During the high dose ato-oxy period, participants will take 5 mg oxybutynin and 0.5mg/kg/day (max 40 mg) atomoxetine nightly for one week. Atomoxetine dose will then be increased to 1.2 mg/kg/day (max 80 mg). During the low dose ato-oxy period, participants will take 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 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 both high dose ato-oxy and low-dose ato-oxy, participants will return for inpatient PSG and health-related quality of life assessment. The primary efficacy endpoint is the change in obstructive AHI from baseline (high dose ato-oxy vs. low dose ato-oxy).

Overall Status Recruiting
Start Date 2020-09-23
Completion Date 2021-09-01
Primary Completion Date 2021-09-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
obstructive apnea-hypopnea index (oAHI) four weeks
Secondary Outcome
Measure Time Frame
Obstructive Sleep Apnea-18 score (OSA-18) four weeks
Arousal Index four weeks
Enrollment 27

Intervention Type: Drug

Intervention Name: Atomoxetine and oxybutynin (ato-oxy)

Description: Low dose ato-oxy will include 0.5 mg/kg/day of atomoxetine (max 40 mg) in combination with 5 mg oxybutynin High dose ato-oxy will include 1.2 mg/kg/day atomoxetine (max 80 mg) and 5 mg oxybutynin



Inclusion Criteria: 1. Male or female participants between 6 to 17 years of age, inclusive, at the Screening Visit. Enrollment will be stratified to ensure equal representation of children age 6-12 and age 13-17. No more than 14 subjects will be randomized for each age group. 2. Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism) Exclusion Criteria: 1. Hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation <90%) 2. Presence of central sleep apnea on polysomnography (central AHI ≥ 5) 3. Currently using and adherent to PAP therapy (>4 hours per night for 70% of nights in the past 30 days based on device download or parent report) 4. MAO inhibitor use 5. Urinary retention 6. Prematurity < 37 weeks estimated gestational age 7. Seizure disorder 8. Untreated or inadequately treated hypothyroidism 9. Significant traumatic brain injury 10. Congenital heart disease and not cleared to participate by the patient's cardiologist 11. History of current, untreated depression 12. History of liver disease 13. 3+ or greater tonsillar hypertrophy.



Minimum Age:

6 Years

Maximum Age:

17 Years

Healthy Volunteers:


Overall Official
Last Name Role Affiliation
Daniel Combs, MD Principal Investigator University of Arizona
Overall Contact

Last Name: Christopher Morton

Phone: (520) 626-4857

Email: [email protected]

Facility: Status: Contact: Investigator: University of Arizona Christopher Morton 520-626-4857 [email protected] Daniel Combs, MD Principal Investigator
Location Countries

United States

Verification Date


Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Arizona

Investigator Full Name: Daniel A. Combs

Investigator Title: Assistant Professor of Pediatrics

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High dose ato-oxy

Type: Active Comparator

Label: Low dose ato-oxy

Type: Active Comparator

Acronym MOSAIC
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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