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RECRUITING
NCT05562388
NA

Mandibular Advancement Device and Changes in Nocturia

Sponsor: Fernanda Yanez Regonesi

View on ClinicalTrials.gov

Summary

The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

Official title: Improvement in Nocturia With MAD and Changes in Polysomnographic Value

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-12-11

Completion Date

2026-03-12

Last Updated

2025-12-15

Healthy Volunteers

No

Interventions

DEVICE

Somnodent Classic

The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States