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

• Conditions: Remotely Controlled Mandibular Positioner
• Interventions: Device: Remotely Controlled Mandibular Positioner (RCMP)

• Registration Number: NCT03231254
• Lead Sponsor: First Hospital of China Medical University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Last Update Submitted: 2017-07-25
• Study First Posted: 2017-07-27
• Last Update Posted: 2017-07-27
• Primary Completion: 2017-10-20
• Study Completion: 2017-10-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chinese patients with OSA	Remotely Controlled Mandibular Positioner (RCMP)	-
Canada patients with OSA	Remotely Controlled Mandibular Positioner (RCMP)	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Frederic Series; 🇨🇦 Quebec City, Quebec, Canada

Wenyang Li; 🇨🇳 Shenyang, Liaoning, China