21
Participants
Start Date
May 10, 2017
Primary Completion Date
October 18, 2018
Study Completion Date
October 18, 2018
Velo-Lingual Bite (BVL)
The administration of the device will proceed according to both the essential requirements of the European directives concerning medical devices (Annex I and X of directive 93/42/EEC) and the clinical practice standards and guidelines provided by the AASM and AASDM. These include the obtainment of alginate impression of both jaws and an interocclusal record, with the mandible at 50% of its maximal protrusive position. Since no single standard titration protocol is available, progressive mandibular advancement will be conducted according to the best available medical standard.
Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Ospedale Civico di Lugano, Ente Ospedaliero Cantonale, Lugano
Mauro Manconi
OTHER