Evidence map›Paper›PMID 40051199›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2025

Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome.

Ambika G Chidambaram, Christopher M Cielo, Inna Chervoneva, Jonathan M Spergel, Ignacio E Tapia

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02180672 (Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT02180672 phase3completednot on this map

Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2014 to 2021Enrolled211ConditionsObstructive Sleep Apnea SyndromeArmsNasal Fluticasone, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Ambika G ChidambaramDivision of Pulmonary and Sleep Medicine, Department of Pediatrics, University of California, Davis, Sacramento, California.
Christopher M CieloDivision of Pulmonary and Sleep Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Inna ChervonevaDivision of Biostatistics, Department of Pharmacology, Physiology and Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.
Jonathan M SpergelDivision of Allergy & Immunology, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Ignacio E TapiaDivision of Pulmonary and Sleep Medicine, Department of Pediatrics, University of Miami Miller School of Medicine, Miami, Florida.

Funding

CLINICAL PHARMACOLOGY TRAINING PROGRAMT32GM008562 · NIGMS · THOMAS JEFFERSON UNIVERSITY · PI WALTER K KRAFT, Scott A. Waldman · 1995 to 2026
$10.2M
Utility of nasal steroids for treatment of childhood obstructive sleep apneaR01HL120909 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI TAPIA, IGNACIO ESTEBAN · 2014 to 2017
$2.5M
NHLBI NIH HHS R01 HL120909NIGMS NIH HHS T32 GM008562
6 · The paper itself

Abstract

STUDY

objectivesNasopharyngeal inflammation contributes to pediatric obstructive sleep apnea syndrome (OSAS). Intranasal corticosteroids (INCS) are used to treat pediatric OSAS; a randomized controlled trial showed an improvement in OSAS symptoms but without polysomnography or neurobehavioral outcome differences. There is a lack of data demonstrating an objective decrease in the nasal inflammatory biomarker profile associated with INCS. Hence, we evaluated the association of nasal inflammatory biomarker profile and response to INCS.

methodsSecondary analysis of a randomized controlled trial of INCS vs placebo in pediatric OSAS (n = 134). The difference in intranasal biomarkers (interleukin (IL)-4, IL-13, tumor necrosis factor-alpha) between the groups after 3 and 12 months was evaluated. The association of the nasal inflammatory biomarker profile and response to INCS was assessed. Multiple regression analysis was performed to identify clinical predictors of response to INCS.

resultsThere were no statistically significant differences in the nasal IL-4, IL-13, and tumor necrosis factor-alpha levels between INCS and placebo groups after 3 and 12 months of treatment. Within the INCS group, there was no statistically significant change in the nasal IL-4, IL-13, and tumor necrosis factor-alpha levels after 3 months of therapy based on responder status. However, among those who received INCS, obesity and a higher obstructive apnea-hypopnea index at baseline were clinical predictors of greater obstructive apnea-hypopnea index after 3 months (

conclusionsINCS did not affect the nasal inflammatory biomarker profile in children with OSAS, including the responders. In addition, INCS is not recommended as a treatment option in children with obesity or high obstructive apnea-hypopnea index at baseline. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Steroids for Pediatric Apnea Research in Kids (SPARK); URL: https://clinicaltrials.gov/study/NCT02180672; Identifier: NCT02180672. CITATION: Chidambaram AG, Cielo CM, Chervoneva I, Spergel JM, Tapia IE. Nasal biomarker inflammatory profile in response to intranasal corticosteroids in pediatric obstructive sleep apnea syndrome.

Indexed as

Adrenal Cortex HormonesInflammationSleep Apnea, ObstructiveAdministration, IntranasalBiomarkersChildDouble-Blind MethodFemaleHumansInterleukin-13Interleukin-4MalePolysomnographySecondary Data AnalysisTreatment OutcomeTumor Necrosis Factor-alphaAdrenal Cortex HormonesBiomarkersInterleukin-13Interleukin-4Tumor Necrosis Factor-alphaintranasal corticosteroidsnasal IL-13nasal IL-4nasal TNF-alphaobstructive apnea-hypopnea indexobstructive sleep apnea syndrome

Identifiers

PMID40051199
PMCPMC12134589

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.