Mandibular Advancement Device and Changes in Nocturia
- Conditions
- Obstructive Sleep ApneaOSANocturia
- Registration Number
- NCT05562388
- Lead Sponsor
- Fernanda Yanez Regonesi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - English speaker<br><br> - >18 y/o<br><br> - Obstructive sleep apnea diagnosis with AHI=5<br><br> - = 2 voiding/night at baseline<br><br> - Upon clinical examination = 8 teeth per arch, range of mandibular protrusion =5 mm<br><br> - Consent to participate in the study.<br><br>Exclusion Criteria:<br><br> - Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy,<br> restless legs syndrome, rapid eye movement sleep behavior disorder).<br><br> - Prostate/kidney problems (urological disease: (eg overactive bladder, benign<br> prostate hyperplasia)<br><br> - Pregnancy<br><br> - Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.<br><br> - Patients using combination therapy for the management of obstructive sleep apnea<br> (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).<br><br> - Upon clinical examination: periodontal disease (>4 mm on periodontal probing, with<br> bleeding on probing, visual signs of periodontal inflammation); tooth horizontal<br> mobility >1 mm, vertical mobility, and unfavorable crown to root ratio; open<br> cavities, loose or fractured restorations, or patient undergoing restorative dental<br> treatments.<br><br> - Exaggerated gag reflex.<br><br> - Lack of coordination or dexterity.<br><br> - Inadequate English comprehension.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To test MAD if associated in changes in nocturia
- Secondary Outcome Measures
Name Time Method Investigate if response to therapy in terms of nocturia is associated with improvement in AHI