Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea

Schwab, Richard J.; Kim, C.; Siegel, Lawrence C.; Keenan, Brendan T.; Black, Jed; Farid-Moayer, Mehran; Podmore, J; Vaska, Matt

doi:10.5665/sleep.3846

Cited by 23 publications

(12 citation statements)

References 28 publications

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“…Nasal EPAP generates end-expiratory pressure leading to increase in functional residual capacity and tracheal traction and a trend towards increase in upper airway cross-sectional area [ 5 ]. On the other hand, expansion of the velopharyngeal airway volume during sleep is associated with improvement in OSA with use of oral appliances or oral pressure therapy [ 38 , 39 ]. Could the variable efficacy of nasal EPAP be related to its limited ability to overcome palatal and tongue base collapse, while having a favorable response in individuals with predominance of hypopharyngeal collapse?…”

Section: Discussionmentioning

confidence: 99%

Nasal Expiratory Positive Airway Pressure Devices (Provent) for OSA: A Systematic Review and Meta-Analysis

et al. 2015

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Objective. To quantify the effectiveness of nasal expiratory positive airway pressure (nasal EPAP) devices or Provent as treatment for obstructive sleep apnea (OSA). Methods. PubMed and six other databases were searched through November 15, 2015, without language limitations. Results. Eighteen studies (920 patients) were included. Pre- and post-nasal EPAP means ± standard deviations (M ± SD) for apnea-hypopnea index (AHI) in 345 patients decreased from 27.32 ± 22.24 to 12.78 ± 16.89 events/hr (relative reduction = 53.2%). Random effects modeling mean difference (MD) was −14.78 events/hr [95% CI −19.12, −10.45], p value < 0.00001. Oxygen desaturation index (ODI) in 247 patients decreased from 21.2 ± 19.3 to 12.4 ± 14.1 events/hr (relative reduction = 41.5%, p value < 0.00001). Lowest oxygen saturation (LSAT) M ± SD improved in 146 patients from 83.2 ± 6.8% to 86.2 ± 11.1%, MD 3 oxygen saturation points [95% CI 0.57, 5.63]. Epworth Sleepiness Scale (ESS) M ± SD improved (359 patients) from 9.9 ± 5.3 to 7.4 ± 5.0, MD −2.5 [95% CI −3.2, −1.8], p value < 0.0001. Conclusion. Nasal EPAP (Provent) reduced AHI by 53.2%, ODI by 41.5% and improved LSAT by 3 oxygen saturation points. Generally, there were no clear characteristics (demographic factors, medical history, and/or physical exam finding) that predicted favorable response to these devices. However, limited evidence suggests that high nasal resistance could be associated with treatment failure. Additional studies are needed to identify demographic and polysomnographic characteristics that would predict therapeutic success with nasal EPAP (Provent).

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Section: Discussionmentioning

confidence: 99%

Nasal Expiratory Positive Airway Pressure Devices (Provent) for OSA: A Systematic Review and Meta-Analysis

et al. 2015

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“…Evaluation of OPT using magnetic resonance imaging may provide insight into the mechanism of action and facilitate identifying clinical predictors. Such work may also stimulate new thinking about how the implementation of OPT can evolve to be suitable for more patients 15. Ongoing research may also lead to refinement of the technology and to consideration of combinations of therapeutic methods.…”

Section: Discussionmentioning

confidence: 99%

Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility

Farid-Moayer¹,

Siegel²,

Black³

2013

NSS

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PurposeThis feasibility study examined the initial-use safety and effectiveness of a new noninvasive oral pressure therapy (OPT) system developed to treat obstructive sleep apnea (OSA).MethodsThe OPT system consists of a console that connects with flexible tubing to a premanufactured polymer mouthpiece. Through the mouthpiece, a pump in the console creates oral vacuum intended to move the soft palate anteriorly to decrease obstruction of the airway during sleep. The mouthpiece was produced in ten different sizes to accommodate a range of oral dimensions. Subjects with OSA in this single-center, single-night study underwent a polysomnography (PSG) study at baseline, followed by PSG during use of OPT.ResultsFifty-six men and 20 women, aged 50.8 ± 12.0 years (mean ± standard deviation [SD]), had OSA with apnea–hypopnea indices (AHI) greater than five events per hour at baseline. Body weight averaged 98.0 ± 18.2 kg (mean ± SD), body mass index ranged from 22.6 kg/m2 to 57.9 kg/m2 and averaged 32.5 ± 5.8 kg/m2 (mean ± SD). OPT was generally well tolerated without any serious adverse events. Baseline AHI was 38.7 ± 27.5 events/hour (mean ± SD) and was reduced with treatment to 24.6 ± 25.7 events/hour (P < 0.001, Cohen’s d 0.53). Treatment produced AHI less than or equal to ten events/hour in 38% of the subjects. Oxygen desaturation index was 30.1 ± 23.7 events/hour at baseline versus 15.8 ± 19.1 events/hour with treatment (P < 0.001, Cohen’s d 0.66). The minimum oxygen saturation increased with treatment from 77.9 ± 8.3 to 82.2 ± 7.9 (P < 0.001, Cohen’s d 0.53). Stage-N1 sleep shifts, total sleep-stage shifts, and awakenings were significantly reduced with treatment.ConclusionThis single-center, single-night feasibility study demonstrates that OPT can improve OSA in certain subjects identifiable by PSG during systematic usage. In appropriately responsive patients, OPT shows potential as a clinically useful new alternative for treatment of OSA without the need for custom manufacture of an oral device component.

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“…[30] Recentemente novos métodos que mensuram a quantidade de gordura, separando gordura e água, foram utilizados mensurando a gordura na língua. [38] Além disso, a RM tem sido utilizada para mensurar modificações na VAS de pacientes com AOS, de acordo com os tratamentos como: perda de peso, [34] no uso de placa de avanço mandibular, [35] uso de novo dispositivo que gera pressão negativa intra-oral [39] e cirurgia na VAS, [40] demonstrando as modificações anatômicas.…”

Section: Anatomia Da Vasunclassified

Efeitos da terapia miofuncional orofacial em pacientes com ronco primário e apneia obstrutiva do sono na anatomia e função da via aérea

Kayamori¹

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Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea

Abstract: Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M. Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea.

Cited by 23 publications

References 28 publications

Nasal Expiratory Positive Airway Pressure Devices (Provent) for OSA: A Systematic Review and Meta-Analysis

Nasal Expiratory Positive Airway Pressure Devices (Provent) for OSA: A Systematic Review and Meta-Analysis

Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility

Efeitos da terapia miofuncional orofacial em pacientes com ronco primário e apneia obstrutiva do sono na anatomia e função da via aérea

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