Osnabrücker Schlafjournal
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Anti-Snoring-Device – First results with a new minimally invasive surgical technique
Patients with primary snoring often complain of distress and social embarrassment and therefore request professional help.
Introduction: Patients with primary snoring often complain of distress and social embarrassment and therefore request professional help. As primary snoring is an innocuous but bothersome parasomnia surgeons have to use least invasive techniques. Aim of this study is to present first data on the safety and efficacy of a new soft palatal implant procedure to reduce palatal flutter as a cause of snoring.
Methods: So far 13 healthy, non-obese patients with primary snoring due to palatal flutter were enrolled into this prospective study. Inclusion criteria were confirmed by questionnaires, clinical and endoscopic examination as well as polysomnography. The Anti-Snoring-Device is a cylindrical implant braided with polyester filaments being preloaded into a specially designed delivery tool. After local disinfection and systemic antibiotic prophylaxis three implants intended for permanent implantation are placed into the soft palate as close to the midline as possible. The entire procedure is performed under local anesthesia. Up to now patients were monitored for 90 days or less. Snoring was assessed by visual analog scale (VAS). The study was conducted according to the declaration of Helsinki and approved by the local ethics committee. All patients gave written informed consent.
Results: The 39 implants could be placed without any complications in all patients. Subjective snoring (VAS) decreased from 7.0 to 2.0 in mean. At the baseline visit snoring was heard in 17% of the patients throughout the home and in 83% in an adjacent room. The bedparnters characterized snoring to be soft and occasional in 50% after 30 and in 100% after 90 days. The ESS decreased from 5.1 to 2.0. Swallowing, taste and speech remained unchanged. There was only a minor increase of throat and mouth pain ending a few days after the procedure in all cases. Two implants were extruded after 30days causing mild pain and swallowing difficulties. After removing them easily under local anethesia the lesions healed without any sequelae. Even in those patients snoring decreased further. There were no severe adverse events. At the 90 days follow up all patients and bedpartners would recommend the procedure to other snorers so far.
Discussion: The Anti-Snoring-Device is a new surgical tool offering a simple procedure with least invasiveness as it does not sacrifice any tissue in order to achieve its purpose.
Our subjective data show its safety, efficacy and good patients´acceptance. However, these data have to be proven in a larger study population also measuring snoring sound and intensity objectively.
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