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

NCT ID: NCT03231254

Last Updated: 2017-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2017-10-29

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.

Conditions

Remotely Controlled Mandibular Positioner

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chinese patients with OSA

Remotely Controlled Mandibular Positioner (RCMP)

Intervention Type: DEVICE

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

Remotely Controlled Mandibular Positioner (RCMP)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laval University

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wenyang Li

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Frederic Series, master

Role: STUDY_DIRECTOR

Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec

Locations

Frederic Series

Québec, Quebec, Canada

Wenyang Li

Shenyang, Liaoning, China

Countries

Canada; China

References

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.

Reference Type: RESULT

PMID: 24082311 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36105925 (View on PubMed)

Other Identifiers

AF-SOP-07-1.0-01

Identifier Type: -

Identifier Source: org_study_id