Mandibular Advancement Device and Changes in Nocturia

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea, Nocturia, OSA

In brief

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

Key facts

Study ID

NCT05562388

Run by

Fernanda Yanez Regonesi

People needed

11

Starts

2023-12-11

Expected to finish

2025-07-30

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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