Evidence map›Paper›PMID 35551600›Full record

Trial reportSleep & breathing = Schlaf & Atmung2023

Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility.

Paula K Schweitzer, James P Maynard, Paul E Wylie, Helene A Emsellem, Scott A Sands

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 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 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
4.4field-weighted citation impact, top 4% 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.

NCT04445688 phase2completednot on this map

Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine

TypeinterventionalSponsorApnimedRan2020 to 2020Enrolled62ConditionsObstructive Sleep ApneaArmsAD036, Atomoxetine, Placebo
NCT07679282 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

TypeinterventionalSponsorSairam ParthasarathyRan2026 to 2032Enrolled2,400ConditionsObstructive Sleep Apnea (OSA)ArmsPositive airway pressure (PAP) therapy, Sleep dental device, Atomoxetine-oxybutynin
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Effect of norepinephrine reuptake inhibitors combined with antimuscarinic agents vs monotherapy for OSA: a systematic review and meta-analysis.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Pooled it
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  7. The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023
    Trial
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  9. Review
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  14. Nocturia and obstructive sleep apnoea.Nature reviews. Urology · 2024
    Review
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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

5 authors at 4 institutions in 1 country.

Paula K SchweitzerSleep Medicine and Research Center, St. Luke's Hospital, 232 South Woods Mill Road, Chesterfield, MO, 63017, USA. paula.schweitzer@stlukes-stl.com.ORCID 0000-0001-6081-1620
James P MaynardCTI Clinical Trial and Consulting, Cincinnati, OH, USA.
Paul E WylieArkansas Center of Sleep Medicine, Little Rock, AR, USA.ORCID 0000-0002-1563-5872
Helene A EmsellemThe Center for Sleep & Wake Disorders, Chevy Chase, MD, and Department of Neurology (Clinical Faculty), George Washington University Medical Center, Washington, DC, USA.
Scott A SandsDivision of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.ORCID 0000-0003-3752-0328
Brigham and Women's Hospital · USClinical Trial and Consulting · USGeorge Washington University · USSt. Luke's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePreliminary studies have shown a significant decrease in severity of obstructive sleep apnea (OSA) with the use of a combination of atomoxetine and oxybutynin, with patients having moderate pharyngeal collapsibility during sleep more likely to respond. This study evaluated the efficacy and safety of AD036 (atomoxetine 80 mg and oxybutynin 5 mg) in the treatment of OSA.

methodsThis trial was a phase 2, randomized, placebo-controlled crossover study comparing AD036, atomoxetine 80 mg alone, and placebo during three home sleep studies, each separated by about 1 week. The trial included patients with OSA and moderate pharyngeal collapsibility as defined by a higher proportion of hypopneas to apneas and mild oxygen desaturation.

resultsOf 62 patients who were randomized, 60 were included in efficacy analyses. The apnea-hypopnea index (AHI) from a median (interquartile range) of 14.2 (5.4 to 22.3) events/h on placebo to 6.2 (2.8 to 13.6) with AD036 and 4.8 (1.4 to 11.6) with atomoxetine alone (p < .0001). Both drugs also decreased the oxygen desaturation index (ODI) and the hypoxic burden (p < .0001). AD036, but not atomoxetine alone, reduced the respiratory arousal index and improved ventilation at the respiratory arousal threshold (greater V

conclusionAD036 significantly improved OSA severity in patients with moderate pharyngeal collapsibility. Atomoxetine may account for the majority of improvement in OSA severity, while the addition of oxybutynin may mitigate the disruptive effect of atomoxetine on sleep and further improve ventilation.

trial registrationClinical trial registered with www. CLINICALTRIALS: gov (NCT04445688).

Indexed as

Sleep Apnea, ObstructiveAtomoxetine HydrochlorideCross-Over StudiesHumansMandelic AcidsSleepAtomoxetine HydrochlorideMandelic AcidsoxybutyninAD036AtomoxetineObstructive sleep apneaOSA pharmacotherapyOxybutynin

Identifiers

PMID35551600
PMCPMC9098382
OpenAlexW4280585822

What OpenQuestion holds

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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 OpenQuestion graph.