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

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

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.

Study Overview

• Status: Unknown
• Conditions: Remotely Controlled Mandibular Positioner
• Intervention / Treatment: Device: Remotely Controlled Mandibular Positioner (RCMP)

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Quebec City, Quebec, Canada, G1V 4G5
      • Frederic Series
• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Wenyang Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Research participants will be respectively recruited from Sleep Centre of IOCPQ of Laval (Quebec, Canada) and CMU first affiliated hospital (Shenyang, China), which receives the majority of referrals from respirologists, psychiatrists, otolaryngologists and dentists practicing in Quebec and Shenyang City. Consecutive patients between 20 and 75 years of age, satisfying the pre-mentioned inclusion will be considered eligible to our study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese patients with OSA	Device: Remotely Controlled Mandibular Positioner (RCMP); 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.
Canada patients with OSA	Device: Remotely Controlled Mandibular Positioner (RCMP); 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.

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	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

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Collaborators: Laval University
• Investigators: Principal Investigator: Wei Wang, PhD, First Hospital of China Medical University; Study Director: Frederic Series, master, Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec

Publications and helpful links

General Publications

• Remmers J, Charkhandeh S, Grosse J, Topor Z, Brant R, Santosham P, Bruehlmann S. Remotely controlled mandibular protrusion during sleep predicts therapeutic success with oral appliances in patients with obstructive sleep apnea. Sleep. 2013 Oct 1;36(10):1517-25, 1525A. doi: 10.5665/sleep.3048.
• Li WY, Masse JF, Gakwaya S, Zhao Z, Wang W, Series F. Differences in Predicted Therapeutic Outcome of Mandibular Advancement Determined by Remotely Controlled Mandibular Positioner in Canadian and Chinese Apneic Patients. Nat Sci Sleep. 2022 Sep 8;14:1611-1622. doi: 10.2147/NSS.S377758. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): October 20, 2017
• Study Completion (Anticipated): October 29, 2017

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: AF-SOP-07-1.0-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No