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

Sponsor

Doctor's Directive Strategies Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT01069068

Collaborator

(none)

Enrollment

Location

1.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr John Viviano and Associates	Mississauga	Ontario	Canada	L5L3P9

Sponsors and Collaborators

Doctor's Directive Strategies Inc.

Investigators

Principal Investigator: John S Viviano, DDS, Dr John Viviano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr John Viviano, Principal Investigator, Doctor's Directive Strategies Inc.

ClinicalTrials.gov Identifier:

NCT01069068

Other Study ID Numbers:

RDD-2009-001

First Posted:

Feb 17, 2010

Last Update Posted:

Dec 9, 2011

Last Verified:

Dec 1, 2011

Keywords provided by Dr John Viviano, Principal Investigator, Doctor's Directive Strategies Inc.

To evaluate the effect of advancing Jaw on airway dimension

Additional relevant MeSH terms:

Sleep Apnea, Obstructive

Study Results

No Results Posted as of Dec 9, 2011