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Active, Not Recruiting

NCT Number: NCT05933603

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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, 86721, 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.
  • Known diagnosis of Down syndrome (trisomy 21, but not translocation or mosaicism)

Exclusion criteria

  • Presence of central sleep apnea on polysomnography (central AHI ≥ 5)
  • 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)
  • Monoamine oxidase inhibitor use
  • Urinary retention
  • Prematurity < 32 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
  • Positive urine pregnancy test
  • Hypoxemia independent of respiratory events on baseline polysomnography (≥5 minutes with oxygen saturation <90%)
  • Presence of central sleep apnea on baseline polysomnography (central AHI ≥ 5)
  • Absence of OSA defined as total AHI <5 on baseline polysomnography

Treatment and study plan

Atomoxetine and oxybutynin (ato-oxy)

Drug

0.5 mg/kg atomoxetine (max 40 mg) and 5 mg oxybutynin by mouth nightly

Primary outcomes

  1. obstructive apnea-hypopnea index (oAHI)

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 6 months

    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. Paired Associates Learning test

    Time frame: 6 months

    Change in Paired Associate Learning test total errors (a measure of memory) from baseline

Other outcomes

  1. Pediatric Quality of Life Inventory (PedsQL) total score

    Time frame: 6 months

    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. Processing speed

    Time frame: 6 months

    Change in processing speed as measured by A-MAP from baseline

  3. Verbal IQ

    Time frame: 6 months

    Change in verbal IQ as measured by the Kaufman Brief IQ Test 2 from baseline

  4. Verbal memory

    Time frame: 6 months

    Change in verbal memory as measured by A-MAP from baseline

  5. Language

    Time frame: 6 months

    Change in child vocalizations/ hour as measured by LENA

  6. Caregiver Global Impression of Change

    Time frame: 6 months

    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.

  7. N1 sleep percentage

    Time frame: 6 months

    Change in N1 sleep percentage on polysomnography from baseline

  8. REM sleep percentage

    Time frame: 6 months

    Change in REM sleep percentage on polysomnography from baseline

  9. N3 sleep percentage

    Time frame: 6 months

    Change in N3 sleep percentage on polysomnography from baseline

  10. Arousal Index

    Time frame: 6 months

    change in number of arousals per hour on polysomnography from baseline

  11. Executive Function

    Time frame: 6 months

    Change in Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite from baseline

  12. Adaptive function

    Time frame: 6 months

    Change in Vineland 3 adaptive behavior composite scale from baseline

  13. Attention Deficit Hyperactivity Disorder symptoms

    Time frame: 6 months

    Change in Conners-3 Attention Deficit Hyperactivity Disorder Index from baseline

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Acronym: MOSAIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2023
Registry last updated
Apr 7, 2026

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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