Evidence map›Paper›PMID 21461326›Full record

Trial reportSleep2011

A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial.

Richard B Berry, Meir H Kryger, Clifford A Massie

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00772044 (Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH), which is not on this map. Cited by 38 papers.

0numbers the graph read from it
0cells of the map it votes in
38citing 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.

NCT00772044 phase4completednot on this map

Randomized, Double-blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-invasive Treatment of OSAH

TypeinterventionalSponsorVentus Medical, Inc.Ran2008 to 2009Enrolled250ConditionsObstructive Sleep Apnea Hypopnea, OSA, OSAHArmsProvent Professional Sleep Apnea Therapy Device, Sham Device
3 · Its place in the literature

Who cites it

38 citing papers in PubMed.

  1. Trial
  2. Expiratory Positive Airway Pressure for Sleep Apnea after Stroke: A Randomized, Crossover Trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2016
    Trial
  3. 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
  4. Trial
  5. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2011
    Trial
  6. Review
  7. Redefining Obstructive Sleep Apnea: Treatment in the Modern Era.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  8. Review
  9. Review
  10. 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
  11. Review
  12. Serendipity.Sleep advances : a journal of the Sleep Research Society · 2023
    Article
  13. Article
  14. Making Sense of the Noise: Toward Rational Treatment for Obstructive Sleep Apnea.American journal of respiratory and critical care medicine · 2020
    Article
  15. Article
  16. Review
  17. Article
  18. Treatment options for obstructive sleep apnea.Neurology. Clinical practice · 2017
    Article
  19. Efficacy of expiratory positive airway pressure nasal device.Sleep & breathing = Schlaf & Atmung · 2016
    Article
  20. 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.

Richard B BerryDivision of Pulmonary, Critical Care, and Sleep Medicine, University of Florida, Gainesville, FL 32610, USA. sleep_doc@msn.com
Meir H Kryger
Clifford A Massie

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesInvestigate the efficacy of a novel nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA).

designA prospective, multicenter, sham-controlled, parallel-group, randomized, double-blind clinical trial.

setting19 sites including both academic and private sleep disorder centers PATIENTS: Obstructive sleep apnea with a pre-study AHI ≥10/hour

interventionsTreatment with a nasal EPAP device (N=127) or similar appearing sham device (N=123) for 3 months. Polysomnography (PSG) was performed on 2 non-consecutive nights (random order: device-on, device-off) at week 1 and after 3 months of treatment. Analysis of an intention to treat group (ITT) (patients completing week 1 PSGs) (EPAP N=119, sham N=110) was performed. MEASUREMENTS AND

resultsAt week 1, the median AHI value (device-on versus device-off) was significantly lower with EPAP (5.0 versus 13.8 events/h, P<0.0001) but not sham (11.6 versus 11.1 events/h, P=NS); the decrease in the AHI (median) was greater (-52.7% vs. -7.3%, P<0.0001) for the ITT group. At month 3, the percentage decrease in the AHI was 42.7% (EPAP) and 10.1% (sham), P<0.0001. Over 3 months of EPAP treatment the Epworth Sleepiness Scale decreased (9.9 ± 4.7 to 7.2 ± 4.2, P<0.0001), and the median percentage of reported nights used (entire night) was 88.2%.

conclusionsThe nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence. CLINICAL TRIAL INFORMATION: REGISTRATIONS: ClinicalTrials.gov. Trial name: Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea (AERO). URL: http://www.clinicaltrials.gov/ct2/show/NCT00772044?term=Ventus&rank=1. REGISTRATION NUMBER: NCT00772044.

Indexed as

Double-Blind MethodFemaleHumansMaleMiddle AgedPolysomnographyPositive-Pressure RespirationProspective StudiesSleepSleep Apnea, ObstructiveTreatment OutcomeCPAPexpiratory positive airway pressureObstructive sleep apnea

Identifiers

PMID21461326
PMCPMC3065258

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.