The Somni Snore Guard (the device) is an intra-oral mouth shield that controls snoring by presenting a barrier to breathing through the mouth during sleep. The device consists of a 1.5mm thick curved vertical body configured to the anatomy of the maxillary and mandibular labiobuccal sulci and a midline horizontal tag on the concave aspect.
Two 3mm diameter holes are located in the body of the device in the mandibular canine region. The device is manufactured by injection moulding. The materials used are a mix of European Standards and USA Food and Drug Administration(FDA)approver Food Grade Ethylene Vinyl Acetate. Manufacture is undertaken at a facility certified for the production of medical accessories.
The device presents in one standard size and is intended for self fit ("boil and bite") adaptation by the user. Immersion in warm water (approx. 70 degrees C) makes the material malleable, allowing for the adaptation to the individual mouth. Upon cooling to body temperature the material remains flexible, while the device retains its moulded shape.
The body of the moulded device rests in the neutral zone of the maxillary and mandibular labiobuccal sulci extending to the premolar region. The horizontal tag rests against the palatal aspect of the anterior teeth and on part of the anterior region of the palate. The passive fit does not inhibit normal nocturnal mouth and tongue movements and does not place stress on the oral structures.
Since it is not actively anchored (to the teeth) the device is readily expelled from the mouth in the event of respiratory distress (eg. nasal blockage). The two holes allow for a measure of pressure equalisation, reducing the incidence of expulsion of the device from the mouth during normal exhalation. The device poses no known risk to the user.
The vast majority of snoring appears to be associated with mouth breathing during sleep. The device presents a barrier to mouth breathing, passively inducing nasal inhalation. Inhaled air thus passes behind the soft palate and tongue, flowing in a laminar stream into the trachea and lungs. Clinical Evaluation was conducted in accordance with the general and ethical protocol of the Committee for Research on Human Subjects of the University of the Witwatersrand, Johannesburg, South Africa. The research showed that near 80% of a wide cross section of chronic snorers benefited from the device. The results of the Clinical Trial were published in the Journal of the Dental Association of South Africa ( Veres, E. Clinical Trial of an Oral Vestibular Shield for the Control of Snoring, Jl. DASA, 48, 15-17).
The device is worn nocturnally and after a short period of adaptation the user finds it unobtrusive and extremely comfortable.
|Speciality:||Health and wellness|
|Address:||Shop 43A, Kolonnade Retail Park, Zambesi Drive, Pretoria|
|Phone:||012 548 5301|