Evidence map›Paper›PMID 24932147›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2014

Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome.

Suraiya A Kureshi, Paul R Gallagher, Joseph M McDonough, Mary Anne Cornaglia, Jill Maggs, John Samuel, Joel Traylor, Carole L Marcus

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01768065 (Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome), 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
1.0field-weighted citation impact, top 22% 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.

NCT01768065 early_phase1completednot on this map

Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2012 to 2013Enrolled15ConditionsOrganic Pediatric Obstructive Sleep ApneaArmsNasal Expiratory Positive Airway Pressure Device, placebo sham
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. [The treatment progress of obstructive sleep apnea in children].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2021
    Review
  2. Debates in pediatric obstructive sleep apnea treatment.World journal of otorhinolaryngology - head and neck surgery · 2021
    Review
  3. Article
  4. Review
  5. Article
  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

8 authors at 1 institution in 1 country.

Suraiya A KureshiSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA ; Divisions of Pulmonary and Sleep Medicine, Children's National Medical Center, Washington, DC.
Paul R GallagherClinical and Translational Research Center, Children's Hospital of Philadelphia, Philadelphia, PA.
Joseph M McDonoughSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Mary Anne CornagliaSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Jill MaggsSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
John SamuelSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Joel TraylorSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Carole L MarcusSleep Center, Children's Hospital of Philadelphia, and University of Pennsylvania, Philadelphia, PA.
Children's Hospital of Philadelphia · US

Funding

INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
PATHOPHYSIOLOGY OF CHILDHOOD OBSTRUCTIVE SLEEP APNEAR01HL058585 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI MARCUS, CAROLE L · 1998 to 2012
$4.3M
NCRR NIH HHS UL1RR024134NHLBI NIH HHS R01 HL58585
6 · The paper itself

Abstract

STUDY

objectivesAlternative therapies for childhood obstructive sleep apnea syndrome (OSAS) are needed as OSAS may persist despite adenotonsillectomy, and continuous positive airway pressure (CPAP) adherence is low. Nasal expiratory positive airway pressure (NEPAP) devices have not been studied in children. We hypothesized that NEPAP would result in polysomnographic improvement. Further, we aimed to determine NEPAP adherence, effects on sleepiness, behavior, and quality of life.

methodsA randomized, double-blind, placebo-controlled, crossover pilot study was performed. CPAP candidates, 8-16 years old, underwent NEPAP and placebo polysomnograms. Subjects with ≥ 50% reduction in the apnea hypopnea index (AHI) from placebo to NEPAP night or AHI < 5/h on NEPAP night wore NEPAP at home for 30 days. Adherence was assessed by daily phone calls/emails and collecting used devices.

resultsFourteen subjects (age 13.4 ± 1.9 years, BMI z-scores 2.2 ± 1 [mean ± SD]) were studied. There was significant improvement in the obstructive apnea index with NEPAP vs. placebo: 0.6 (0-21.1)/h vs. 4.2 (0-41.9)/h (median [range], p = 0.010) and trends for improvement in other polysomnographic parameters. However, responses were variable, with 3 subjects not improving and 2 worsening. Older children and those with less hypercapnia had a better response. Eight subjects were sent home with devices; one was lost to follow-up, and adherence in the remainder was 83% of nights; these subjects had a significant improvement in sleepiness and quality of life.

conclusionsNEPAP devices are a potential alternative therapy for OSAS in a small subset of children. Due to variability in individual responses, efficacy of NEPAP should be evaluated with polysomnography. CLINICAL

trial registrationwww.clinicaltrials.gov, identifier: NCT01768065.

Indexed as

AdolescentChildCross-Over StudiesDouble-Blind MethodFemaleHumansMalePatient CompliancePilot ProjectsPolysomnographyPositive-Pressure RespirationSleep Apnea, Obstructivenasal expiratory positive airway pressureobstructive sleep apnea syndromepediatrics

Identifiers

PMID24932147
PMCPMC4031408
OpenAlexW2324266947

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.