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

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01069068
• Lead Sponsor: Doctor's Directive Strategies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Dr John Viviano and Associates; 🇨🇦 Mississauga, Ontario, Canada