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

Mehran Farid-Moayer,1 Lawrence C Siegel,2,3 Jed Black41Peninsula Sleep Center, Burlingame, CA, USA; 2Department of Anesthesia, Stanford University School of Medicine, Stanford, CA, USA; 3Department of Clinical Affairs, ApniCure, Inc, Redwood City, CA, USA; 4Stanford Center for Sleep Research and Med...

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Autores principales:	Farid-Moayer M, Siegel LC, Black J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495
Acceso en línea:	https://doaj.org/article/057d19e2652b411eac503451f7af3237
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spelling	oai:doaj.org-article:057d19e2652b411eac503451f7af32372021-12-02T00:12:58ZOral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility1179-1608https://doaj.org/article/057d19e2652b411eac503451f7af32372013-05-01T00:00:00Zhttp://www.dovepress.com/oral-pressure-therapy-for-treatment-of-obstructive-sleep-apnea-clinica-a13046https://doaj.org/toc/1179-1608Mehran Farid-Moayer,1 Lawrence C Siegel,2,3 Jed Black41Peninsula Sleep Center, Burlingame, CA, USA; 2Department of Anesthesia, Stanford University School of Medicine, Stanford, CA, USA; 3Department of Clinical Affairs, ApniCure, Inc, Redwood City, CA, USA; 4Stanford Center for Sleep Research and Medicine, Stanford University School of Medicine, Stanford, CA, USAPurpose: This 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).Methods: The 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.Results: Fifty-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.Conclusion: This 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.Keywords: apnea–hypopnea index, obstructive sleep apnea, oral pressure, therapy, treatmentFarid-Moayer MSiegel LCBlack JDove Medical PressarticlePsychiatryRC435-571Neurophysiology and neuropsychologyQP351-495ENNature and Science of Sleep, Vol 2013, Iss default, Pp 53-59 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495
spellingShingle	Psychiatry RC435-571 Neurophysiology and neuropsychology QP351-495 Farid-Moayer M Siegel LC Black J Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
description	Mehran Farid-Moayer,1 Lawrence C Siegel,2,3 Jed Black41Peninsula Sleep Center, Burlingame, CA, USA; 2Department of Anesthesia, Stanford University School of Medicine, Stanford, CA, USA; 3Department of Clinical Affairs, ApniCure, Inc, Redwood City, CA, USA; 4Stanford Center for Sleep Research and Medicine, Stanford University School of Medicine, Stanford, CA, USAPurpose: This 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).Methods: The 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.Results: Fifty-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.Conclusion: This 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.Keywords: apnea–hypopnea index, obstructive sleep apnea, oral pressure, therapy, treatment
format	article
author	Farid-Moayer M Siegel LC Black J
author_facet	Farid-Moayer M Siegel LC Black J
author_sort	Farid-Moayer M
title	Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
title_short	Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
title_full	Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
title_fullStr	Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
title_full_unstemmed	Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
title_sort	oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/057d19e2652b411eac503451f7af3237
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Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility

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