Mandibular Advancement Device and Changes in Nocturia

Launched by FERNANDA YANEZ REGONESI · Sep 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether using a mandibular advancement device (MAD), which is a type of mouthguard designed to help with breathing during sleep, can reduce the need to wake up at night to urinate, a condition known as nocturia. The researchers want to find out if this device can improve sleep quality for people who have obstructive sleep apnea (OSA) and experience nocturia.

To participate in this study, you need to be at least 18 years old, speak English, and have been diagnosed with OSA, which means you have trouble breathing while sleeping. You should also be waking up at least twice a night to urinate. However, there are some reasons you might not be eligible, such as having other sleep disorders, certain medical conditions like heart failure or diabetes, or specific dental issues. If you join the study, you can expect to use the MAD device and help researchers learn more about its effects on nighttime urination. The study is currently looking for participants, so if you think you might qualify, it could be a great opportunity to contribute to important research.

Gender

ALL

Eligibility criteria

• 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.