Evidence map›Paper›PMID 22003339›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2011

Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).

Meir H Kryger, Richard B Berry, Clifford A Massie

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00849043 (A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT00849043 completednot on this map

A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea

TypeobservationalSponsorVentus Medical, Inc.Ran2009 to 2010Enrolled65ConditionsObstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.

  1. Trends in CPAP adherence over twenty years of data collection: a flattened curve.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2016
    Pooled it
  2. Reconsidering first-line treatment for obstructive sleep apnea: a systematic review of the literature.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale · 2016
    Pooled it
  3. The efficacy of a chinstrap in treating sleep disordered breathing and snoring.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2014
    Trial
  4. 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
  5. Safety principles of lowering inspiratory pressure.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
    Article
  6. Development of a guide for continuous positive airway pressure use - A good fit: Making continuous positive airway pressure work for you.Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR · 2025
    Article
  7. Recent advances in managing obstructive sleep apnea.World journal of clinical cases · 2024
    Article
  8. Article
  9. Article
  10. Serendipity.Sleep advances : a journal of the Sleep Research Society · 2023
    Article
  11. Making Sense of the Noise: Toward Rational Treatment for Obstructive Sleep Apnea.American journal of respiratory and critical care medicine · 2020
    Article
  12. Review
  13. Observational
  14. Efficacy of expiratory positive airway pressure nasal device.Sleep & breathing = Schlaf & Atmung · 2016
    Article
  15. Review
  16. Obstructive sleep apnoea syndrome and its management.Therapeutic advances in chronic disease · 2015
    Review
  17. Review
  18. Review
  19. Review
  20. Alternative devices for obstructive sleep apnea.Neurology. Clinical practice · 2013
    Article
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

3 authors at 2 institutions in 1 country.

Meir H KrygerGaylord Sleep Medicine, Gaylord Hospital, Wallingford, CT 06492, USA. mhkryger@yahoo.com
Richard B Berry
Clifford A Massie
Gaylord Hospital · USUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesEvaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA).

designA prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trial

setting13 sites including both academic and private sleep disorder centers PATIENTS: OSA patients in the EPAP arm of the EPAP vs sham randomized study who used the EPAP device ≥ 4 h per night, ≥ 5 nights per week on average during months 1 and 2 of the 3-month trial and had ≥ 50% reduction in AHI or AHI reduction to < 10 documented by polysomnography, comparing the 3-month device-on PSG to the week-one device-off PSG.

interventionsTreatment with a nasal EPAP device (N = 41) for 12 months. Polysomnography (PSG) on the patients wearing the device was performed after 12 months of treatment. The month 12 device-on PSG data from the analyzable subject cohort (N = 34) was compared to the week 1 device-off PSG from the EPAP vs sham trial. MEASUREMENTS AND

resultsOf the 51 patients eligible, 34 were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events/h (week 1 device-off versus month 12 device-on). The decrease in the AHI (median) was 71.3% (p < 0.001). The median proportion of sleep time with snoring was reduced by 74.4% (p < 0.001). Over 12 months of EPAP treatment, the Epworth Sleepiness Scale decreased (11.1 ± 4.2 to 6.0 ± 3.2, p < 0.001), and the median percentage of reported nights used (entire night) was 89.3%.

conclusionsNasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment. Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study. CLINICAL

trial registrationClinicalTrials.gov TRIAL NAME: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E). URL: http://clinicaltrials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2. REGISTRATION NUMBER: NCT00849043.

Indexed as

Cohort StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedPatient CompliancePolysomnographyPositive-Pressure RespirationProspective StudiesSleep Apnea, ObstructiveTimeTreatment OutcomeCPAPexpiratory positive airway pressureObstructive sleep apnea

Identifiers

PMID22003339
PMCPMC3190843
OpenAlexW2038060845

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.