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

NCT ID: NCT01069068

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Keywords

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To evaluate the effect of advancing Jaw on airway dimension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Doctor's Directive Strategies Inc.

OTHER

Sponsor Role lead

Responsible Party

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Dr John Viviano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John S Viviano, DDS

Role: PRINCIPAL_INVESTIGATOR

Dr John Viviano

Locations

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Dr John Viviano and Associates

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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RDD-2009-001

Identifier Type: -

Identifier Source: org_study_id