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Mandibular Advancement Device and Changes in Nocturia | Clinical Trials | Clareo Health

RECRUITINGNA

Mandibular Advancement Device and Changes in Nocturia

Improvement in Nocturia With MAD and Changes in Polysomnographic Value

NCT05562388•Fernanda Yanez Regonesi

Summary

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

Detailed Description

After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•English speaker
•\>18 y/o
•Obstructive sleep apnea diagnosis with AHI≥5
•≥ 2 voiding/night at baseline
•Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
•Consent to participate in the study.

Exclusion Criteria

•Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
•Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia)
•Pregnancy
•Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
•Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
•Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
•Exaggerated gag reflex.
•Lack of coordination or dexterity.
•Inadequate English comprehension.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

December 11, 2023

Primary Completion Date

March 12, 2026

Completion Date

March 12, 2026

Last Updated

December 15, 2025

Enrollment

ESTIMATED participants

Conditions

Obstructive Sleep ApneaNocturiaOSA

Interventions

Somnodent Classic

DEVICE

Contacts

Fernanda Yanez Regonesi, DDS, MS

CONTACT

8593235500 fya232@uky.edu

Isabel Moreno Hay, DDS, PhD

CONTACT

8593235500 imo226@uky.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Mandibular Advancement Device and Changes in Nocturia

Inclusion Criteria

Exclusion Criteria

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