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

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 Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5L3P9
      • Dr John Viviano and Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	one 60 minute session

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth	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	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	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	one 60 minute session

Collaborators and Investigators

• Sponsor: Doctor's Directive Strategies Inc.
• Investigators: Principal Investigator: John S Viviano, DDS, Dr John Viviano

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): December 9, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: To evaluate the effect of advancing Jaw on airway dimension
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: RDD-2009-001