Efficacy of a Novel MAD in OSA

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

May 10, 2017

Primary Completion Date

October 18, 2018

Study Completion Date

October 18, 2018

Conditions
Sleep Apnea, ObstructiveApnea, ObstructiveOSAOSAHObstructive Sleep ApneaObstructive Sleep Apnea Syndrome
Interventions
DEVICE

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.

Trial Locations (1)

6900

Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Ospedale Civico di Lugano, Ente Ospedaliero Cantonale, Lugano

All Listed Sponsors
lead

Mauro Manconi

OTHER

NCT03196583 - Efficacy of a Novel MAD in OSA | Biotech Hunter | Biotech Hunter