Clinical trial NCT01069068: Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
Official title: Assessment of the Impact of a Stepped Mouthpiece on the Upper Airways Measured Through Acoustic Pharyngometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: To evaluate the effect of advancing Jaw on airway dimension
Lead sponsor: Doctor's Directive Strategies Inc.
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: one 60 minute session
Secondary outcomes:
measure: Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth
timeFrame: one 60 minute session
measure: 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
timeFrame: one 60 minute session
measure: 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
timeFrame: one 60 minute session
measure: 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
timeFrame: one 60 minute session
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Dr John Viviano and Associates
state: Ontario
Study officials:
affiliation: Dr John Viviano
name: John S Viviano, DDS
role: PRINCIPAL_INVESTIGATOR
References: