Mandibular Advancement Device and Changes in Nocturia

Study Overview
=================
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.

Official Title
-----------------
Improvement in Nocturia With MAD and Changes in Polysomnographic Value

Conditions
-----------------
Nocturia, Obstructive Sleep Apnea, OSA

Intervention / Treatment
-----------------
* Device: Somnodent Classic


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAD therapy<br>MAD Therapy | Device: Somnodent Classic<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test MAD if associated in changes in nocturia | Assessment of efficacy of device in terms of nocturia: Patients will complete daily questionnaires to evaluate voiding at night. Average of 2 preceding weeks of the follow up will be used to determine treatment success in terms of nocturia. Once less than 2 voidings per night is achieved participants will be considers reponders in terms of nocturia and second sleep study will be performed. | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate if response to therapy in terms of nocturia is associated with improvement in AHI | Once participants report less than 2 voiding per night on average (2 week period), second sleep study will be performed and 50% improvement in apnea hypopnea index will be considered treatment success. | 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, oral appliance, nocturia, mandibular advancement device