UK Center for Clinical and Translational Science

Mandibular Advancement Device and Changes in Nocturia

Purpose

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

Conditions

Obstructive Sleep Apnea
Nocturia
OSA

Eligibility

Eligible Ages: Between 18 Years and 80 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Uncontrolled open label clinical trial. Data gathers from recruitment until appliance delivery will be used allowing each participant to also be their own control, as wait list type of study.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental MAD therapy	MAD Therapy	Device: Somnodent Classic The efficacy of the device will be evaluated in regards to the response of nocturia. Once patients report an average of voiding per night of less than 2 in the preceding 2 weeks of the follow up they will be classified as responders in term of nocturia and will be evaluated with a second sleep study. Efficacy of MAD will be assessed by comparing the apnea hypopnea index (AHI) values of pre and post sleep study with MAD, and they will be classified as responders if they have 50% improvement in AHI.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

Contact:
Fernanda Yanez Regonesi, DDS, MS
859-323-5500
fya232@uky.edu

More Details

NCT ID: NCT05562388
Status: Recruiting
Sponsor: Fernanda Yanez Regonesi

Study Contact

Fernanda Yanez Regonesi, DDS, MS
8593235500
fya232@uky.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.