Evidence map›Paper›PMID 37555595›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2023

The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.

Daniel Combs, Jamie Edgin, Chiu-Hsieh Hsu, Kenneth Bottrill, Hailey Van Vorce, Blake Gerken, Daniel Matloff, Sicily La Rue, Sairam Parthasarathy

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04115878 phase2completednot on this map

Evaluation of Atomoxetine and Oxybutynin for Obstructive Sleep Apnea in Children With Down Syndrome

TypeinterventionalSponsorUniversity of ArizonaRan2020 to 2022Enrolled22ConditionsObstructive Sleep Apnea, Down SyndromeArmsAtomoxetine and oxybutynin (ato-oxy)
NCT07280468 phase4recruitingnot on this mapstarted 2026, after this paper: background citation

Endotype DIrected Treatment for OSA in Down Syndrome

TypeinterventionalSponsorUniversity of ArizonaRan2026 to 2030Enrolled200ConditionsObstructive Sleep Apnea (OSA), Down SyndromeArmsato-oxy, Oxygen
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Treatment of OSA beyond adenotonsillectomy.Pediatric pulmonology · 2025
    Review
  6. Article
  7. A Review of Clinical Trials in Down Syndrome.International review of research in developmental disabilities · 2025
    Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Daniel CombsUAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
Jamie EdginDepartment of Psychology, University of Arizona, Tucson, Arizona.
Chiu-Hsieh HsuMel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona.
Kenneth BottrillDepartment of Psychology, University of Arizona, Tucson, Arizona.
Hailey Van VorceDepartment of Psychology, University of Arizona, Tucson, Arizona.
Blake GerkenUAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
Daniel MatloffUAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
Sicily La RueUAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
Sairam ParthasarathyUAHS Center for Sleep & Circadian Sciences, University of Arizona, Tucson, Arizona.
University of Arizona · US

Funding

Medications for Obstructive Sleep Apnea to Improve Cognition in Children with Down Syndrome (MOSAIC DS)R33HL151254 · NHLBI · UNIVERSITY OF ARIZONA · PI COMBS, DANIEL · 2022 to 2025
$1.3M
DEtermining Capacity and Informing Down syndrome Assent Strategies (DECIDAS)R21HD109777 · NICHD · UNIVERSITY OF ARIZONA · PI COMBS, DANIEL · 2022 to 2023
$422k
NHLBI NIH HHS R33 HL151254NICHD NIH HHS R21 HD109777
6 · The paper itself

Abstract

STUDY

objectivesChildren with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA). Current OSA treatments have limited effectiveness in this population. We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome.

methodsChildren ages 6-7 years old with Down syndrome and OSA participated in a double-blind crossover clinical trial evaluating two dose regimens of ato-oxy. Participants received low-dose ato-oxy (0.5 mg/kg atomoxetine and 5 mg oxybutynin) and high-dose ato-oxy (1.2 mg/kg atomoxetine and 5 mg oxybutynin) for 1 month in random order. The primary study outcome was change in obstructive apnea-hypopnea index. Health-related quality of life as measured by the OSA-18 as well as changes in sleep architecture were secondary outcomes.

resultsFifteen participants qualified for randomization and 11 participants had complete data at all points. Baseline obstructive apnea-hypopnea index was 7.4 ± 3.7 (mean ± standard deviation), obstructive apnea-hypopnea index with low-dose ato-oxy was 3.6 ± 3.3 (

conclusionsAto-oxy is a promising treatment for OSA in children with Down syndrome. CLINICAL

trial registrationRegistry: Clinicaltrials.gov; Name: Medications for Obstructive Sleep Apnea In Children With Down Syndrome (MOSAIC); URL: https://clinicaltrials.gov/ct2/show/NCT04115878; Identifier: NCT04115878. CITATION: Combs D, Edgin J, Hsu C-H, et al. The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.

Indexed as

Down SyndromeSleep Apnea, ObstructiveAtomoxetine HydrochlorideChildDouble-Blind MethodHumansMandelic AcidsQuality of LifeTreatment OutcomeAtomoxetine HydrochlorideMandelic AcidsoxybutyninDown syndromeobstructive sleep apnea

Identifiers

PMID37555595
PMCPMC10692944
OpenAlexW4385684537

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.