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NCT04115878 · ClinicalTrials.gov registry record · Phase 2
Medications for Obstructive Sleep Apnea In Children With Down Syndrome
A Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04115878: Completed Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, sponsored by University of Arizona.
NCT04115878 is a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome that has completed, run by University of Arizona. The registered enrollment target is 22 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115878, a Phase 2 study of Obstructive Sleep Apnea and Down Syndrome, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
change in number of obstructive apneas and hypopneas per hour on polysomnography from baseline
Conditions Studied
Interventions
- DRUG Atomoxetine and oxybutynin (ato-oxy)
Study Locations (1)
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-10-21 |
| Est. Completion | 2022-12-30 |
| Phase | Phase 2 |
What the finished NCT04115878 record still lists
NCT04115878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Atomoxetine and oxybutynin (ato-oxy) is the first listed.
NCT04115878 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04115878 about?
NCT04115878 is a clinical study titled "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. Duri...
What is the current status of trial NCT04115878?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-10-21. Estimated completion is 2022-12-30.
What conditions does trial NCT04115878 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Down Syndrome.
What interventions are being tested in trial NCT04115878?
The interventions under investigation include: Atomoxetine and oxybutynin (ato-oxy) (DRUG).
Who is sponsoring clinical trial NCT04115878?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04115878 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04115878's enrollment target sits among peer trials
22 136th of 155 higher than 18 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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