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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069068
• Other study ID #: RDD-2009-001
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: December 7, 2011
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: December 2011
• Source: Doctor's Directive Strategies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	Dr John Viviano and Associates	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Doctor's Directive Strategies Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth		one 60 minute session	No
Secondary	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	No
Secondary	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	No
Secondary	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	No