Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2009
A multicenter, prospective study of a novel nasal EPAP device in the treatment of obstructive sleep apnea: efficacy and 30-day adherence.
Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
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.
Who cites it
16 citing papers in PubMed.
- 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 · 2016Trial
- 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 · 2014Trial
- 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 · 2011Trial
- Trial
- Predictors of response to a nasal expiratory resistor device and its potential mechanisms of action for treatment of obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2011Trial
- Making Sense of the Noise: Toward Rational Treatment for Obstructive Sleep Apnea.American journal of respiratory and critical care medicine · 2020Article
- Study design considerations for sleep-disordered breathing devices.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020Article
- A review of EPAP nasal device therapy for obstructive sleep apnea syndrome.Sleep & breathing = Schlaf & Atmung · 2015Review
- Nasal Expiratory Positive Airway Pressure Devices (Provent) for OSA: A Systematic Review and Meta-Analysis.Sleep disorders · 2015Review
- Advances in the treatment of obstructive sleep apnea.Current treatment options in neurology · 2014Article
- Improvements in current treatments and emerging therapies for adult obstructive sleep apnea.F1000prime reports · 2014Review
- Innovative treatments for adults with obstructive sleep apnea.Nature and science of sleep · 2014Review
- Review
- Treating obstructive sleep apnea with positive pressure therapy.Current treatment options in neurology · 2011Article
- Updates on definition, consequences, and management of obstructive sleep apnea.Mayo Clinic proceedings · 2011Review
- Auto-PEEP to treat obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2009Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
STUDY
objectivesEvaluate the efficacy of a novel device placed in the nares that imposes an expiratory resistance for the treatment of obstructive sleep apnea (OSA) and evaluate adherence to the device over a 30-day in-home trial period.
designOne diagnostic and 3 treatment polysomnograms were administered in a Latin-square design to identify the optimal expiratory resistance to be used during the 30-day in-home trial. Subjects had repeat polysomnography with the prescribed device at the end of the 30-day trial.
settingMulticenter study.
participantsParticipants (N=34; age 27 to 67) with a baseline apnea-hypopnea index (AHI) > or =5. MEASUREMENTS AND
resultsThe AHI was reduced from 24.5 _ 23.6 (mean +/- SD) to an average of 13.5 +/- 18.7 (p < 0.001) across initial treatment nights. The AHI was 15.5 +/-+/- 18.9 (p = 0.001) for the prescribed device at the end of the 30-day trial. Of 24 subjects with an AHI > 10 at baseline, 13 achieved an AHI < 10 on the initial treatment nights; 10 had a similar response on the final treatment night. Percent of the night snoring decreased from 27.5 +/- 23.2 to 11.6 +/- 13.7 (p < 0.001) on initial treatment nights and 14.6 +/- 20.6 (p = 0.013) at the end of the trial; Epworth Sleepiness scores decreased from 8.7 +/- 4.0 at baseline to 6.9 +/- 4.4 (p < 0.001) at the end of the trial; the Pittsburgh Sleep Quality Index improved from 7.4 +/- 3.3 to 6.5 +/- 3.6 (p = 0.042). Mean oxygen saturation increased from 94.8 +/- 2.0 to 95.2 +/- 1.9 (p = 0.023) on initial treatment nights and 95.3 +/- 1.9 (p = 0.003) at the end of the trial. Sleep architecture was not affected. Participants reported using the device all night long for 94% of nights during the in-home trial.
conclusionsTreatment with this novel device was well tolerated and accepted by the participants. An overall reduction in AHI was documented; however, therapeutic response was variable among the participants. Further research is required to identify the ideal candidates for this new therapeutic option in the management of OSA.
Indexed as
Identifiers
20465019PMC2792968What Socratic holds
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.