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A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility

التفاصيل البيبلوغرافية
العنوان: A novel implantable device for the treatment of obstructive sleep apnea: clinical safety and feasibility
المؤلفون: Pavelec V, Rotenberg BW, Maurer JT, Gillis E, Verse T
المصدر: Nature and Science of Sleep, Vol 2016, Iss Issue 1, Pp 137-144 (2016)
بيانات النشر: Dove Medical Press, 2016.
سنة النشر: 2016
المجموعة: LCC:Psychiatry
LCC:Neurophysiology and neuropsychology
مصطلحات موضوعية: Obstructive sleep apnea, implantable device, surgical treatment, breathing, sleep, tongue base, Psychiatry, RC435-571, Neurophysiology and neuropsychology, QP351-495
الوصف: Vaclav Pavelec,1,2 Brian W Rotenberg,3 Joachim T Maurer,4 Edward Gillis,5 Thomas Verse6 1LENTE Clinic, 2Faculty of Health Studies of West Bohemia University, Plzen, Czech Republic; 3Department of Otolaryngology, Head and Neck Surgery, Western University, London, ON, Canada; 4Department of Otorhinolaryngology, Head and Neck Surgery, University Medicine Mannheim, Mannheim, Germany; 5ReVENT Medical, Inc., Newark, CA, USA; 6Department of Otorhinolaryngology, Head and Neck Surgery, Asklepios Klinikum Harburg, Hamburg, GermanyObjective: Many cases of obstructive sleep apnea (OSA) involve collapse of the tongue base and soft palate during sleep, causing occlusion of the upper airway and leading to oxygen desaturation. Existing therapies can be effective, but they are plagued by patient adherence issues and the invasiveness of surgical approaches. A new, minimally invasive implant for OSA has been developed, which is elastic and contracts a few weeks after deployment, stabilizing the surrounding soft tissue. The device has had good outcomes in preclinical testing; this report describes the preliminary feasibility and safety of its implementation in humans.Patients and methods: A prospective, multicenter, single-arm feasibility study was conducted. Subjects were adults with moderate-to-severe OSA who had previously failed or refused conventional continuous positive airway pressure treatment. Intraoperative feasibility data, postoperative pain, and safety information were collected for a 30-day postoperative period.Results: Forty subjects participated (37 men, three women; average age of 46.1 years); each received two tongue-base implants and two soft-palate implants. Surgical procedure time averaged 43 minutes. Postsurgical pain resolved readily in most cases; at 30 days post implantation,
نوع الوثيقة: article
وصف الملف: electronic resource
اللغة: English
تدمد: 1179-1608
Relation: https://www.dovepress.com/a-novel-implantable-device-for-the-treatment-of-obstructive-sleep-apne-peer-reviewed-article-NSS; https://doaj.org/toc/1179-1608
URL الوصول: https://doaj.org/article/d2a2b6a78c88413f9eb1735f1711b39b
رقم الأكسشن: edsdoj.2a2b6a78c88413f9eb1735f1711b39b
قاعدة البيانات: Directory of Open Access Journals
الوصف
تدمد:11791608