Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
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ClinicalTrials.gov Identifier: NCT01069068
: February 17, 2010
Last Update Posted
: December 9, 2011
Doctor's Directive Strategies Inc.
Information provided by (Responsible Party):
Dr John Viviano, Doctor's Directive Strategies Inc.
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). [ Time Frame: one 60 minute session ]
Secondary Outcome Measures
Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth [ Time Frame: one 60 minute session ]
Measurement of the upper airways through acoustic pharyngometry during slow and deep breathing while the subject uses a stepped mouthpiece. The acoustic pharyngometry measurement will be performed at mid inhalation [ Time Frame: one 60 minute session ]
Assessment of the most comfortable position when using the stepped mouthpiece during both "tidal" and "slow and deep breathing". The scoring of the "comfortable position" will be performed through a Likert-style questionnaire [ Time Frame: one 60 minute session ]
The most "comfortable position" established as outlined above will be evaluated for comfort while holding that position for 3 minutes. After the 3 minutes, the subject's level of comfort will be re-evaluated through a Likert-style questionnaire [ Time Frame: one 60 minute session ]
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Ages Eligible for Study:
19 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study will be performed as an open investigation including 60 subjects. The 60 subjects will be stratified such that 30 subjects should have been diagnosed with OSA, and 30 subjects should not have been diagnosed with OSA.
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.
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.