gms | German Medical Science

78. Jahresversammlung der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e. V.

Deutsche Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie e. V.

16.05. - 20.05.2007, München

Placebo-controlled studies in ENT-surgery: Palatal implants in OSA

Meeting Abstract

German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. 78th Annual Meeting of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. Munich, 16.-20.05.2007. Düsseldorf, Köln: German Medical Science; 2007. Doc07hno119

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/hno2007/07hno119.shtml

Veröffentlicht: 8. August 2007

© 2007 Maurer et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

The efficacy of Pillar® implants in the treatment of obstructive sleep apnea (OSA) has been investigated in prospective case series only. Based on the availalable data we compared Pillar treatment with placebo in a randomized way.

22 patients with mild to moderate OSA (RDI 10-30, BMI<32, age 18-75 years) were enrolled into this prospective, randomized, double-blind, placebo-controlled study. There was no clear site of obstruction in the clinical-endoscopic examination. The treatment group (mean RDI 19.9) received three implants under local anesthesia near the midline at the junction of hard and soft palate; the procedure was exactly the same in the placebo group (mean RDI 15.2), however the implant in the insertion needle was missing. Respiratory parameters (polysomnography), snoring (bed partner assessment), sleepiness (self assessment) and postoperative morbidity were assessed at baseline and 90 days after surgery.

All 22 procedures were performed without any complications. There were no implant extrusions. Up to now, the first 10 patients could be unblinded. In the placebo group, the RDI increased to 19.4, whereas it decreased to 9.9 in the treatment group (p<0.05). Hypopneas could be reduced relevantly compared to apneas which remained unchanged.

In OSA treatment, Pillar® implants seem to be superior to placebo.