Mandibular Advancement Device and Changes in Nocturia

Last updated: August 20, 2025
Sponsor: Fernanda Yanez Regonesi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nocturia

Sleep Apnea Syndromes

Treatment

Somnodent Classic

Clinical Study ID

NCT05562388
DENT-22-MAD
177 - DR - 22
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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, benignprostate 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, withbleeding on probing, visual signs of periodontal inflammation); tooth horizontalmobility >1 mm, vertical mobility, and unfavorable crown to root ratio; opencavities, loose or fractured restorations, or patient undergoing restorative dentaltreatments.

  • Exaggerated gag reflex.

  • Lack of coordination or dexterity.

  • Inadequate English comprehension.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Somnodent Classic
Phase:
Study Start date:
December 11, 2023
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

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