Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry

Doctor's Directive Strategies Inc.60 enrolled

Overview

Mandibular advancements during tidal breathing, achieved through a stepped mouthpiece design, affect the size of the upper airways in subjects with and without Obstructive Sleep Apnea.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects must provide written informed consent to participate in the study. * Adult male or female subjects over 18 years of age who have or have not been diagnosed with OSA. * Subjects claiming no history of OSA should take the Epworth questionnaire and obtain a result less than 10. * Subjects must satisfy the study investigator about their fitness to participate in the study. * Subjects must be available to complete the study. Exclusion Criteria: * Subjects not compliant with the instructions for use of the stepped mouthpiece and the study procedures. * Subjects who have participated in a clinical trial in the previous month.

Locations (1)

Dr John Viviano and Associates

Mississauga, Ontario, Canada

Outcomes

Primary Outcomes

To measure the impact of different horizontal mandibular advancements, achieved through a stepped mouthpiece design, on the size of the upper airways in subjects with and without Obstructive Sleep Apnea (OSA).