Using a mouth device to reduce nighttime urination in sleep apnea patients
Improvement in Nocturia With MAD and Changes in Polysomnographic Value
This study tests if a special mouth device can help people with sleep apnea reduce how often they wake up at night to use the bathroom.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05562388 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether the use of a mandibular advancement device (MAD) can lead to reductions in nocturia among patients diagnosed with obstructive sleep apnea. Participants will be fitted with the MAD and will complete questionnaires to assess their nocturia symptoms at baseline and during follow-ups. The device will be adjusted every two weeks until participants report fewer than two nighttime voids. A second sleep study will be conducted to measure the effectiveness of the treatment once the desired nocturia reduction is achieved.
Who should consider this trial
Good fit: Ideal candidates include English-speaking adults over 18 with a diagnosis of obstructive sleep apnea and experiencing at least two voids per night.
Not a fit: Patients with other sleep disorders, urological diseases, or those on combination therapy for obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from both obstructive sleep apnea and nocturia.
How similar studies have performed: While the specific combination of MAD use and nocturia reduction is novel, similar studies have shown positive outcomes with MADs in managing obstructive sleep apnea.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Fernanda Yanez Regonesi, DDS, MS — University Of Kentucy
- Study coordinator: Fernanda Yanez Regonesi, DDS, MS
- Email: fya232@uky.edu
- Phone: 8593235500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.