Evidence map›Paper›PMID 34596039›Full record

ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2022

Variable negative external pressure-an alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: a pilot study.

Jerrold A Kram, Rafael Pelayo

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04718142 (Variable Negative External Pressure), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.2field-weighted citation impact, top 45% 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.

NCT04718142 nacompletednot on this map

Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study

TypeinterventionalSponsorSomne, LLCRan2020 to 2021Enrolled28ConditionsObstructive Sleep ApneaArmsvNEP
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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

2 authors at 1 institution in 1 country.

Jerrold A KramCalifornia Center for Sleep Disorders, San Leandro, California.
Rafael PelayoPsychiatry and Behavioral Sciences-Stanford Center for Sleep Sciences and Medicine, Redwood City, California.
In-Q-Tel · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesTo assess variable negative external pressure (vNEP) therapy using a range of pressures and varying collar sizes and shapes to identify combinations that improve the efficacy and comfort of this emerging therapy for obstructive sleep apnea (OSA).

methodsThis prospective, open-label pilot study included 28 eligible patients (71% men) having documented moderate OSA (apnea-hypopnea index [AHI] 15 events/h ≤ AHI ≤ 30 events/h) at 1 sleep clinic for an overnight, in-lab sleep trial. Each participant tested at least 2 of 6 available vNEP devices during sleep periods ≥ 2 hours. During the assessment of AHI by polysomnography, negative pressures of -20 cm H

resultsTwenty (71%) of the participants responded to vNEP therapy: excellent response (AHI ≤ 5 events/h) was observed in 14 (50%); 6 (21%) achieved a partial response (AHI ≤ 50% baseline). For the 20 responders, the therapy reduced the fraction of total sleep time when peripheral oxygen saturation < 90% and improved minimum pulse oximetry oxygen saturation. Six patients experienced a minor, self-limited adverse event. Twenty-six participants (93%) stated that they would use vNEP nightly.

conclusionsIn this pilot study, vNEP therapy markedly improved AHI and oxygenation in most patients with moderate OSA. The majority of participants found vNEP comfortable and preferable to prevailing OSA therapies. Further development and studies of vNEP are warranted. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Study of Variable Negative External Pressure (vNEP) in Reducing Respiratory Event in Individuals With OSA; URL: https://clinicaltrials.gov/ct2/show/NCT04718142; Identifier: NCT04718142. CITATION: Kram JA, Pelayo R. Variable negative external pressure-An alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: A pilot study.

Indexed as

Continuous Positive Airway PressureSleep Apnea, ObstructiveFemaleHumansMalePilot ProjectsPolysomnographyProspective StudiesTreatment Outcomemedical devicenegative pressure therapyobstructive sleep apnea

Identifiers

PMID34596039
PMCPMC8807896
OpenAlexW3201904297

What OpenQuestion holds

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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.