Clinical trial NCT05562388: Mandibular Advancement Device and Changes in Nocturia
Official title: Improvement in Nocturia With MAD and Changes in Polysomnographic Value
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Nocturia
OSA
Keywords: obstructive sleep apnea
oral appliance
nocturia
mandibular advancement device
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: American Academy of Dental Sleep Medicine
First posted: 2022-09-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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

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.

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.

Primary outcomes:
measure: To test MAD if associated in changes in nocturia
timeFrame: 15 weeks
Secondary outcomes:
measure: Investigate if response to therapy in terms of nocturia is associated with improvement in AHI
timeFrame: 15 weeks
Other outcomes:
measure: Changes in quality of life
timeFrame: 15 weeks
measure: Change in fatigue
timeFrame: 15 weeks
measure: Changes in insomnia
timeFrame: 15 weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University Of Kentucy
name: Fernanda Yanez Regonesi, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: