Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring

NAUnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Snoring
Interventions
DEVICE

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."

Trial Locations (1)

40218

RECRUITING

Norton Clinical Research Group, Louisville

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Delta Dental Foundation

OTHER

lead

Norton Healthcare

OTHER