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Atomoxetine + Oxybutynin for Sleep Apnea in Down Syndrome (MOSAIC Trial)
Phase 2
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MOSAIC Trial Summary
This trial tests if combining atomoxetine and oxybutynin can improve sleep apnea in children with Down Syndrome. Participants receive the combination for 6 months and undergo screenings to measure their sleep and quality of life.
Who is the study for?
Children aged 6-17 with Down syndrome and obstructive sleep apnea can join this trial. They must have a confirmed diagnosis of trisomy 21 Down syndrome, not due to translocation or mosaicism. Kids with untreated depression, hypothyroidism, severe prematurity, certain heart diseases without clearance, or those on specific medications like MAO inhibitors cannot participate.Check my eligibility
What is being tested?
The study tests a combination medication called ato-oxy (atomoxetine and oxybutynin) given before bedtime for six months to see if it improves sleep apnea and cognition in children with Down syndrome. The effectiveness is measured by changes in the number of breathing pauses during sleep from the start to the end of treatment.See study design
What are the potential side effects?
Possible side effects of ato-oxy may include dry mouth, constipation, difficulty urinating, dizziness upon standing up quickly due to low blood pressure (orthostatic hypotension), increased heart rate (tachycardia), and potential mood changes.
MOSAIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 17 years old.
Select...
I have been diagnosed with Down syndrome.
MOSAIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
Obstructive Sleep Apnea-18 score (OSA-18)
Paired Associates Learning test
Other outcome measures
Adaptive function
Arousal Index
Attention Deficit Hyperactivity Disorder symptoms
+10 moreMOSAIC Trial Design
1Treatment groups
Experimental Treatment
Group I: Ato-oxyExperimental Treatment1 Intervention
0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin
Find a Location
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,814 Total Patients Enrolled
9 Trials studying Down Syndrome
1,781 Patients Enrolled for Down Syndrome
University of ArizonaLead Sponsor
515 Previous Clinical Trials
148,678 Total Patients Enrolled
1 Trials studying Down Syndrome
22 Patients Enrolled for Down Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,088 Total Patients Enrolled
10 Trials studying Down Syndrome
1,109 Patients Enrolled for Down Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tonsils are significantly enlarged.You are pregnant, as confirmed by a urine test.I have depression that I haven't treated yet.I have a seizure disorder.I use my sleep apnea device regularly, as recommended.You were born before 32 weeks of pregnancy.My thyroid condition is untreated or not well-managed.You have low oxygen levels in your blood during sleep, even when you're not having breathing troubles.I am taking monoamine oxidase inhibitors.You don't have obstructive sleep apnea, which is a condition where you stop breathing multiple times during sleep.You have been diagnosed with central sleep apnea based on a sleep test.I am between 6 and 17 years old.I have been diagnosed with Down syndrome.You have had a serious head injury.I have difficulty emptying my bladder completely.You have a specific type of sleep disorder called central sleep apnea.I have a history of liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Ato-oxy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can juveniles participate in this medical experiment?
"Data suggests that participants in this research trial should be between 6 and 17 years of age. Additionally, 413 studies for minors have been conducted while 1193 trials are available to patients over 65."
Answered by AI
Is Ato-oxy a viable option considering potential risks?
"Based on our assessment, Ato-oxy was assigned a score of 2 due to the existent evidence supporting its safety but lack thereof with regard to efficacy."
Answered by AI
Are there any available slots for participants of this clinical trial?
"According to the clinicaltrials.gov database, enlistment in this medical study has closed; it was initially posted on July 1st 2023 and last updated June 26th of the same year. However, there are currently 1666 other trials that remain open for recruitment."
Answered by AI
Am I eligible to be included in this research endeavor?
"A total of 36 patients with obstructive sleep apnea who are aged between 6 and 17 years old can be enlisted in this medical trial."
Answered by AI
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