Evidence mapPaperPMID 40158847Full record

Trial reportChest2025

Effects of the Combination of Pimavanserin and Atomoxetine on OSA Severity: A Randomized Crossover Trial.

Ludovico Messineo, Madison Preuss, Ali Azarbarzin, Daniel Vena, Laura Gell, Atqiya Aishah, Neda Esmaeili, Molly Kim, Isabel Burdick, Tom Chen and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05350215 (Effect of Atomoxetine and DAW2022 on OSA Severity), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
field-weighted citation impact
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.

NCT05350215 phase1 / phase2recruitingnot on this map

Effect of Atomoxetine and DAW2022 on OSA Severity

TypeinterventionalSponsorBrigham and Women's HospitalRan2022 to 2026Enrolled18ConditionsObstructive Sleep ApneaArmsPlacebo oral capsule, Atomoxetine Oral Capsule [Strattera]
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
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  5. Review
  6. Review
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

13 authors.

Ludovico MessineoDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA. Electronic address: ludovico.messineo@yahoo.it.
Madison PreussDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Ali AzarbarzinDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Daniel VenaDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Laura GellDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Atqiya AishahDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Neda EsmaeiliDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Molly KimDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Isabel BurdickDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Tom ChenDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA.
David WhiteDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Scott A SandsDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.
Andrew WellmanDivision of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham & Women's Hospital and Harvard Medical School, Boston, MA.

Funding

Validation of a Phenotype Model to Predict Response to Alternative OSA TreatmentsR01HL102321 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI WELLMAN, DAVID ANDREW · 2011 to 2025
$7.3M
Determination of the site of pharyngeal collapse in Obstructive Sleep Apnea patients from snoring soundsR01HL128658 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI WELLMAN, DAVID ANDREW · 2016 to 2025
$4.3M
NHLBI NIH HHS R01 HL102321NHLBI NIH HHS R01 HL128658
6 · The paper itself

Abstract

backgroundOSA pharmacologic interventions like the noradrenergic muscle stimulant atomoxetine have wake-promoting properties. Pimavanserin, a promising serotonin 2 RESEARCH QUESTION: What is the effect of the combination of pimavanserin and atomoxetine on apnea-hypopnea index (AHI; primary outcome), arousal index, and nadir oxygen saturation (Spo STUDY DESIGN AND

methodsAfter baseline polysomnography, 18 participants with OSA (AHI > 15 events/h) took pimavanserin plus atomoxetine (34/80 mg; 34/40 mg for the first 3 days) or placebo for 1 week according to a randomized, crossover, 2-period, double-masked clinical trial. Follow-up polysomnography was performed to provide study outcomes. Safety outcomes, subjective sleep quality, and flow-estimated endotypes (using oronasal pneumotachograph flow) also were explored.

resultsEleven and 7 participants were randomized to atomoxetine plus pimavanserin and placebo first, respectively. The combination reduced AHI by 42% (95% CI, 18%-60%) vs placebo, meeting the primary outcome (P < .001). Absolute AHI reduction was 16.9 events/h (95% CI, 8.1-23.6 events/h) more than placebo. Nadir Spo

interpretationOur results indicate that pimavanserin with atomoxetine is a strong pharmacologic therapy candidate for OSA. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT05350215; URL: www. CLINICALTRIALS: gov.

Indexed as

Adrenergic Uptake InhibitorsAtomoxetine HydrochloridePiperidinesSerotonin 5-HT2 Receptor AntagonistsSleep Apnea, ObstructiveUreaAdultCross-Over StudiesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPolysomnographySeverity of Illness IndexAdrenergic Uptake InhibitorsAtomoxetine HydrochloridepimavanserinPiperidinesSerotonin 5-HT2 Receptor AntagonistsUreahypnoticsOSA alternative treatmentsOSA endotypingpharmacotherapy

Identifiers

PMID40158847
PMCPMC13169405

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.