30
Participants
Start Date
June 1, 2021
Primary Completion Date
December 31, 2023
Study Completion Date
December 31, 2023
Delta Dental Oral Device
"The oral device is designed to move the genioglossus forward, with interior attachments to maintain the placement of the tongue on the floor of the mouth forward. In addition, bite plates made of the Ethylene-vinyl acetate (EVA) plastic were fabricated and embedded with the mouthpiece to encourage subjects to bite down and push the tongue under the interior lower attachment. The upper plate is made of the same material and slightly opens the bite to improve oral air flow further. The primary component of the mouthpiece is fabricated with Vistamaxx material, which is semi-crystalline 2mm co-polymer that can be molded by the user with Nurse assistance to provide a custom fit.~The subject will be fitted by moistening and heating in a microwave. Tthe research staff member will assist to ensure proper fit with both the lower and upper dental devices.~The subject then completes the data collection portion regarding using the SnoreLab app and survey completion as previously described."
RECRUITING
Norton Clinical Research Group, Louisville
Lead Sponsor
Delta Dental Foundation
OTHER
Norton Healthcare
OTHER