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High dose ato-oxy for Obstructive Sleep Apnea (MOSAIC Trial)

Phase 2
Waitlist Available
Led By Daniel Combs, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four weeks
Awards & highlights

MOSAIC Trial Summary

This trial is testing whether a combination of atomoxetine and oxybutynin (ato-oxy) can improve obstructive sleep apnea (OSA) in children with Down syndrome (DS) better than either drug alone.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Down Syndrome

MOSAIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
obstructive apnea-hypopnea index (oAHI)
Secondary outcome measures
Arousal Index
Obstructive Sleep Apnea-18 score (OSA-18)
Other outcome measures
Caregiver Global Impression of Change
N1 sleep percentage
N3 sleep percentage
+2 more

MOSAIC Trial Design

2Treatment groups
Active Control
Group I: High dose ato-oxyActive Control1 Intervention
Group II: Low dose ato-oxyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,572 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,572 Total Patients Enrolled
Daniel Combs, MDPrincipal InvestigatorUniversity of Arizona
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Medications for Obstructive Sleep Apnea In Children With Down Syndrome
Daniel A. Combs 2020. "Medications for Obstructive Sleep Apnea In Children With Down Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04115878.
~5 spots leftby Apr 2025
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