Mandibular Advancement Device and Changes in Nocturia

NCT05562388 | Completed FDA Device

• 2 other identifiers: DENT-22-MAD177 - DR - 22
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea; Nocturia; OSA

Keywords

obstructive sleep apnea; oral appliance; nocturia; mandibular advancement device

Outcome Measures

Primary Outcomes (1)

• To test MAD if associated in changes in nocturia

  Assessment of efficacy of device in terms of nocturia: Patients will complete daily questionnaires to evaluate voiding at night. Average of 2 preceding weeks of the follow up will be used to determine treatment success in terms of nocturia. Once less than 2 voidings per night is achieved participants will be considers reponders in terms of nocturia and second sleep study will be performed.

  15 weeks

Secondary Outcomes (1)

• Investigate if response to therapy in terms of nocturia is associated with improvement in AHI

  15 weeks

Other Outcomes (3)

• Changes in quality of life

  15 weeks

• Change in fatigue

  15 weeks

• Changes in insomnia

  15 weeks

Study Arms (1)

MAD therapy

EXPERIMENTAL

MAD Therapy

Device: Somnodent Classic

Interventions

Somnodent Classic DEVICE

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.

MAD therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fernanda Yanez Regonesi: lead
• American Academy of Dental Sleep Medicine: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Nocturia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fernanda Yanez Regonesi, DDS, MS

  University Of Kentucy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 30, 2022
• Study Start: December 11, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)