Evidence map›Paper›PMID 22334807›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2012

Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children.

Carole L Marcus, Suzanne E Beck, Joel Traylor, Mary Anne Cornaglia, Lisa J Meltzer, Natalie DiFeo, Laurie R Karamessinis, John Samuel, Jennifer Falvo, Michelle DiMaria and 3 more

2 registry-linked trialsOpen 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, 2012. 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 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
4.6field-weighted citation impact, top 5% 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.

NCT00458406 nacompletednot on this map

Evaluation of Adherence and Therapeutic Effectiveness of BiPAP With Bi-Flex Versus CPAP in Children With Obstructive Sleep Apnea

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2007 to 2012Enrolled60ConditionsObstructive Sleep ApneaArmsBi-Flex, CPAP
NCT04124471 nacompletednot on this mapstarted 2019, after this paper: background citation

Positive Airway Pressure for the Treatment of the Obstructive Sleep Apnea Syndrome in Children With Down Syndrome (Stage 1)

TypeinterventionalSponsorChildren's Hospital of PhiladelphiaRan2019 to 2022Enrolled42ConditionsDown Syndrome, Obstructive Sleep ApneaArmsOpen-ended semi-structured interviews
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Trial
  4. Trial
  5. Pilot study of nasal expiratory positive airway pressure devices for the treatment of childhood obstructive sleep apnea syndrome.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2014
    Trial
  6. Trial
  7. Article
  8. Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Debates in pediatric obstructive sleep apnea treatment.World journal of otorhinolaryngology - head and neck surgery · 2021
    Review
  14. Review
  15. Continuous positive airway pressure for obstructive sleep apnea in children.Canadian family physician Medecin de famille canadien · 2021
    Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. Adherence to Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea in Children With Developmental Disabilities.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Carole L MarcusSleep Center, Children’s Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. marcus@email.chop.edu
Suzanne E Beck
Joel Traylor
Mary Anne Cornaglia
Lisa J Meltzer
Natalie DiFeo
Laurie R Karamessinis
John Samuel
Jennifer Falvo
Michelle DiMaria
Paul R Gallagher
Heidi Beris
Mary Kate Menello
Children's Hospital of Philadelphia · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo determine the effects of bilevel positive airway pressure with pressure release technology (Bi-Flex) on adherence and efficacy in children and adolescents compared to standard continuous positive airway pressure (CPAP) therapy. We hypothesized that Bi-Flex would result in improved adherence but similar efficacy to CPAP.

methodsThis was a randomized, double-blinded clinical trial. Patients with obstructive sleep apnea were randomized to CPAP or Bi-Flex. Repeat polysomnography was performed on pressure at 3 months. Objective adherence data were obtained at 1 and 3 months.

results56 children and adolescents were evaluated. There were no significant differences in the number of nights the device was turned on, or the mean number of minutes used at pressure per night for CPAP vs Bi-Flex (24 ± 6 vs 22 ± 9 nights, and 201 ± 135 vs 185 ± 165 min, respectively, for Month 1). The apnea hypopnea index decreased significantly from 22 ± 21/h to 2 ± 3/h on CPAP (p = 0.005), and 18 ± 15/h to 2 ± 2/h on Bi-Flex (p < 0.0005), but there was no significant difference between groups (p = 0.82 for CPAP vs Bi-Flex). The Epworth Sleepiness Scale decreased from 8 ± 5 to 6 ± 3 on CPAP (p = 0.14), and 10 ± 6 to 5 ± 5 on Bi-Flex (p < 0.0005; p = 0.12 for CPAP vs Bi-Flex).

conclusionsBoth CPAP and Bi-Flex are efficacious in treating children and adolescents with OSAS. However, adherence is suboptimal with both methods. Further research is required to determine ways to improve adherence in the pediatric population.

Indexed as

Continuous Positive Airway PressurePatient ComplianceAdolescentAge FactorsChildChild, PreschoolDouble-Blind MethodFemaleHumansMaleObesityPolysomnographySleep Apnea, ObstructiveTreatment OutcomeBi-FlexCPAPobstructive sleep apnea

Identifiers

PMID22334807
PMCPMC3266335
OpenAlexW2164537448

What OpenQuestion 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 OpenQuestion graph.