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Mandibular Advancement Device and Changes in Nocturia

NCT05562388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-04-13

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • American Academy of Dental Sleep Medicine

    collaborator UNKNOWN

  • Fernanda Yanez Regonesi

    lead OTHER

Principal Investigators

  • Fernanda Yanez Regonesi, DDS, MS · University Of Kentucy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05562388 on ClinicalTrials.gov