Clinical trial NCT03231254: Differences in Predicted Therapeutic Outcome of Oral Appliance Determined by RCMP in Quebec Versus Shenyang Patients With OSA.
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Remotely Controlled Mandibular Positioner
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: Laval University
First posted: 2017-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: The differences of predicted therapeutic outcome of OA between two groups.
timeFrame: 2017.7-2017.11
Secondary outcomes:
measure: The differences of optimal protrusion position determined by Remotely Controlled Mandibular Positioner (RCMP) with overnight PSG in Quebec versus Shenyang patients with OSA.
timeFrame: 2017.7-2017.11
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Frederic Series
state: Quebec
city: Shenyang
country: China
facility: Wenyang Li
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Wei Wang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pneumologue Institut Universitaire de Cardiologie et de Pneumologie de Québec
name: Frederic Series, master
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.