Evidence map›Paper›PMID 27784415›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2017

Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial.

Frédéric Gagnadoux, Dirk Pevernagie, Poul Jennum, Nina Lon, Corinne Loiodice, Renaud Tamisier, Petra van Mierlo, Wojciech Trzepizur, Martina Neddermann, Annika Machleit and 2 more

Open access · bronzeAbstract readRandomized Controlled TrialValidation Study
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. A longitudinal study of the accuracy of positive airway pressure therapy machine-detected apnea-hypopnea events.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  9. Electronic health record-derived outcomes in obstructive sleep apnea managed with positive airway pressure tracking systems.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  10. Article
  11. Review
  12. Use of the WatchPAT to detect occult residual sleep-disordered breathing in patients on CPAP for obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020
    Article
  13. Article
  14. Improvement in Sleep-Disordered Breathing Indices Downloaded From a Positive Airway Pressure Machine Following Conversion of Atrial Fibrillation to Sinus Rhythm.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2018
    Article
  15. Urgent Need to Improve PAP Management: The Devil Is in Two (Fixable) Details.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017
    Article
  16. Man Versus Machine.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 5 countries.

Frédéric GagnadouxUniversité d'Angers, Angers, France; CHU d'Angers, Département de Pneumologie, Angers, France.
Dirk PevernagieSleep Medicine Centre, Kempenhaeghe, HEEZE, The Netherlands.
Poul JennumDanish Center for Sleep Medicine, University of Copenhagen, Glostrup Hospital.
Nina LonDanish Center for Sleep Medicine, University of Copenhagen, Glostrup Hospital.
Corinne LoiodiceUniversity Grenoble Alpes, Grenoble, France.
Renaud TamisierUniversity Grenoble Alpes, Grenoble, France.
Petra van MierloSleep Medicine Centre, Kempenhaeghe, HEEZE, The Netherlands.
Wojciech TrzepizurUniversité d'Angers, Angers, France; CHU d'Angers, Département de Pneumologie, Angers, France.
Martina NeddermannEv. Krankenhaus Herne, Schlaflabor, Herne, Germany.
Annika MachleitEv. Krankenhaus Herne, Schlaflabor, Herne, Germany.
Jeffrey JaskoPhilips Home Healthcare Solutions, Murrysville, PA.
Jean Louis PépinUniversity Grenoble Alpes, Grenoble, France.
Centre Hospitalier Universitaire de Grenoble · FRUniversité d'Angers · FRUniversity of Copenhagen · DKGhent University · BEKempenhaeghe · NLPhilips (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesAutotitrating continuous positive airway pressure (CPAP) devices adjust pressure in response to changes in airflow and are an alternative to attended in-laboratory titration polysomnography (PSG) to determine optimal pressure levels. The aim of this study was to compare the performance of the System One RemStar Auto A-Flex (Philips Respironics, Murrysville, PA, USA) automatically adjusted positive airway pressure (APAP) mode to manually titrated, fixed pressure CPAP and to validate the device's breathing event detection capabilities against attended in-laboratory PSG.

methodsSixty-one patients investigated in five centers for moderate to severe obstructive sleep apnea between May 2012 and June 2013 were invited to participate. Participants underwent two full-night attended polysomnograms in random order with manually titrated, fixed pressure CPAP versus APAP.

resultsFifty-three participants with a mean apnea-hypopnea index (AHI) of 45.9 ± 23 completed two sleep studies and were included in the analysis. There were significant but not clinically relevant differences between APAP and CPAP respectively: Apnea index [1.0 (2.8 ± 0.8), median (mean ± standard deviation)] versus [1.8 (5.3 ± 11.5)], p = 0.004; percentage of N1 sleep [12.3 (15.9 ± 0.5)] versus [14.3 (18.9 ± 12.7)], p = 0.028. AHI values differed between PSG [2.8 (5.5. ± 9.3)] and device [3.7 (6.0 ± 8.6)], p = 0.003). Regarding residual events detection, intraclass correlation coefficients for AHI were strong (0.956, p < 0.001) and the area under the curve was 0.988 (AHI cut-off value of 10).

conclusionsThe new APAP modality was effective and residual apnea-hypopnea indices calculated by the device strongly correlated to those assessed by PSG. COMMENTARY: A commentary on this article appears in this issue on page 167.

Indexed as

ApneaContinuous Positive Airway PressureCross-Over StudiesDouble-Blind MethodEuropeFemaleHumansMaleMiddle AgedPolysomnographyReproducibility of ResultsSleep Apnea, ObstructiveAPAPCPAPresidual event detectionsleep apnea

Identifiers

PMID27784415
PMCPMC5263084
OpenAlexW2544659810

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.