Differences in Predicted Therapeutic Outcome of Oral Appliance Determined by RCMP in Quebec Versus Shenyang Patients With OSA.

Study Overview
=================
Brief Summary
-----------------
Study Objective: To explore the differences in predicted therapeutic outcome of OA and optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA. Design: A prospective, inter-ethnic pilot study. Setting: Two Standard sleep disorder clinical care in Quebec (Canada) and Shenyang (China), with oral appliance titration tests performed in sleep laboratory. Participants: Consecutive specific OSA patients, who are potential candidates for treatment of OSA with an oral appliance (n=100, 50 Canadian, 50 Chinese), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologist and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2). Interventions: A mandibular protrusive titration study in the PSG lab using a RCMP not only predicts the eventual therapeutic outcome but also prospectively determines Optimal Protrusive Position (OPP) for participants predicted to be therapeutically successful with OA therapy. One goal of this study is to identify OA favorable candidates by physicians using prospectively and explicitly designed criteria. Analyses of the predicted therapeutic outcome of OA and OPP between the two ethnic populations (patients in Quebec and Shenyang) will be processed after matching for OSA severity.

Official Title
-----------------
Differences in Predicted Therapeutic Outcome of Oral Appliance and Optimal Protrusion Position Determined by Remotely Controlled Mandibular Positioner (RCMP) With Overnight PSG in Quebec Versus Shenyang Patients With OSA

Conditions
-----------------
Remotely Controlled Mandibular Positioner

Intervention / Treatment
-----------------
* Device: Remotely Controlled Mandibular Positioner (RCMP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent diagnosis of OSAS (AHI>15/h) announced by a sleep recording; mean oxygen saturation >90%; mandibular range of motion >5 mm; adequate dentition: ≥10 upper and 10 lower teeth. Exclusion Criteria: (1). Body mass index 40 kg/m2 or greater; (2).Inability to tolerate overnight polysomnography in sleep lab; (3).>50% of observed sleep apneas being central; (4). Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome; (5). Those with severe pharyngeal obstruction on physical exam (pharyngeal grade more than II); (6).severe nasal obstruction.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese patients with OSA<br> | Device: Remotely Controlled Mandibular Positioner (RCMP)<br>* RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.<br>|
| Canada patients with OSA<br> | Device: Remotely Controlled Mandibular Positioner (RCMP)<br>* RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of predicted therapeutic outcome of OA between two groups. | To identify and compare the number of OA favorable candidates by physicians using prospectively and explicitly designed criteria in both groups. | 2017.7-2017.11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA. |  | 2017.7-2017.11 |