Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.

NACompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

August 2, 2023

Study Completion Date

August 2, 2023

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

Orthoapnea NOA®

The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: \> 50% reduction of AHI/RDI. Criterion II: AHI/RDI \< 5 events/hour or \<15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI \>5 events/hour with OSA associates symptoms.

Trial Locations (1)

40536

Orofacial Pain Center, Lexington

All Listed Sponsors
lead

Isabel Moreno Hay

OTHER

NCT05139303 - Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea. | Biotech Hunter | Biotech Hunter