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Completed

NCT Number: NCT04115878

Medications for Obstructive Sleep Apnea In Children With Down Syndrome

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).

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Key information

Conditions

Obstructive Sleep Apnea Abnormalities, Multiple Apnea Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Dyssomnias Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Hypoxemia independent of respiratory events on polysomnography (≥5 minutes with oxygen saturation <90%)
  • Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
  • 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)
  • MAO inhibitor use
  • Urinary retention
  • Prematurity < 37 weeks estimated gestational age
  • Seizure disorder
  • Untreated or inadequately treated hypothyroidism
  • Significant traumatic brain injury
  • Congenital heart disease and not cleared to participate by the patient's cardiologist
  • History of current, untreated depression
  • History of liver disease
  • 3+ or greater tonsillar hypertrophy.

Treatment and study plan

Atomoxetine and oxybutynin (ato-oxy)

Drug

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

Primary outcomes

  1. Obstructive Apnea-hypopnea Index (oAHI)

    Time frame: four weeks

    change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline

Secondary outcomes

  1. Obstructive Sleep Apnea-18 Score (OSA-18)

    Time frame: four weeks

    Change in OSA-18 (a measure of health-related quality of life) from baseline. The OSA-18 score ranges from 18 to 136, with lower scores indicating better health-related quality of life.

  2. Arousal Index

    Time frame: four weeks

    change in number of arousals per hour on polysomnography from baseline

Other outcomes

  1. Pediatric Quality of Life Inventory (PedsQL) Total Score

    Time frame: four weeks

    Change in PedsQL total score (a measure of health-related quality of life) from baseline. The PedsQL score ranges from 0-100, with higher scores indicating better health-related quality of life.

  2. Caregiver Global Impression of Change

    Time frame: four weeks

    Change in Caregiver Global Impression of Change from baseline. This will be assessed on a seven point scale answering the question: Since the start of this therapy, my child's overall status is: 1. Very much improved; 2. Much improved; 3. Minimally Improved; 4. No change; 5. Minimally worse; 6. Much worse or 7. Very much worse.

  3. N1 Sleep Percentage

    Time frame: four weeks

    Change in N1 sleep percentage on polysomnography from baseline

  4. REM Sleep Percentage

    Time frame: four weeks

    Change in REM sleep percentage on polysomnography from baseline

  5. N3 Sleep Percentage

    Time frame: four weeks

    Change in N3 sleep percentage on polysomnography from baseline

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: MOSAIC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 4, 2019
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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