Obstructive Sleep ApneaPhase 2MOSAICNCT05933603
Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
A Phase 2 study testing Atomoxetine and Oxybutynin (ato-oxy) in people with Obstructive Sleep Apnea and Down Syndrome, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Obstructive Sleep Apnea, Down Syndrome
- What is being tested?
- Atomoxetine and Oxybutynin (ato-oxy)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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)
- 3. Absence of OSA defined as total AHI <5 on baseline polysomnography
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obstructive Sleep Apnea, Down Syndrome
- Being tested
- Atomoxetine and Oxybutynin (ato-oxy)
- Medical subject headings
- Sleep Apnea, Obstructive, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine and Oxybutynin (ato-oxy)Drug
0.5 mg/kg atomoxetine (max 40 mg) and 5 mg oxybutynin by mouth nightly
| Study group | Role | What they receive |
|---|---|---|
| Ato-oxy | Experimental | 0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin Receives: Drug: Atomoxetine and Oxybutynin (ato-oxy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
obstructive apnea-hypopnea index (oAHI)
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline (% change)
Measured: 6 months
Secondary outcomes (2)
Obstructive Sleep Apnea-18 score (OSA-18)
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.
Measured: 6 months
Paired Associates Learning test
Change in Paired Associate Learning test total errors (a measure of memory) from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start29 Sep 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933603
- Sponsor's protocol ID
- 1908864846v2
- Other IDs
- R33HL151254
- Acronym
- MOSAIC
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available via a database such as sleepdata.org.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05933603
- Acronym / sponsor ID
- MOSAIC / 1908864846v2
- Conditions
- Obstructive Sleep Apnea, Down Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ato-oxy | Experimental | Drug: Atomoxetine and Oxybutynin (ato-oxy)0.5 mg/kg (max 40 mg) atomoxetine and 5 mg oxybutynin |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine and Oxybutynin (ato-oxy)0.5 mg/kg atomoxetine (max 40 mg) and 5 mg oxybutynin by mouth nightly | Drug | Ato-oxy |
Primary outcome
obstructive apnea-hypopnea index (oAHI)
Time frame: 6 months
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline (% change)
2 secondary outcomes
Obstructive Sleep Apnea-18 score (OSA-18)
Time frame: 6 months
Paired Associates Learning test
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be made available via a database such as sleepdata.org.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine and Oxybutynin (ato-oxy) in people with Obstructive Sleep Apnea and Down Syndrome, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obstructive apnea-hypopnea index (oAHI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.