Status:
UNKNOWN
Differences in Predicted Therapeutic Outcome of Oral Appliance Determined by RCMP in Quebec Versus Shenyang Patients With OSA.
Lead Sponsor:
First Hospital of China Medical University
Collaborating Sponsors:
Laval University
Conditions:
Remotely Controlled Mandibular Positioner
Eligibility:
All Genders
20-75 years
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 ...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
July 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 29 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03231254
Start Date
July 1 2017
End Date
October 29 2017
Last Update
July 27 2017
Active Locations (2)
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1
Frederic Series
Québec, Quebec, Canada, G1V 4G5
2
Wenyang Li
Shenyang, Liaoning, China, 110001