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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069068
First Posted: February 17, 2010
Last Update Posted: December 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr John Viviano, Doctor's Directive Strategies Inc.
  Purpose
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
Obstructive Sleep Apnea

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr John Viviano, Doctor's Directive Strategies Inc.:

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). [ Time Frame: one 60 minute session ]

Secondary Outcome Measures:
  • Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: one 60 minute session ]

Enrollment: 60
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069068


Locations
Canada, Ontario
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
  More Information

Responsible Party: Dr John Viviano, Principal Investigator, Doctor's Directive Strategies Inc.
ClinicalTrials.gov Identifier: NCT01069068     History of Changes
Other Study ID Numbers: RDD-2009-001
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: December 9, 2011
Last Verified: December 2011

Keywords provided by Dr John Viviano, Doctor's Directive Strategies Inc.:
To evaluate the effect of advancing Jaw on airway dimension

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases