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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr John Viviano, Doctor's Directive Strategies Inc.
ClinicalTrials.gov Identifier:
NCT01069068
First received: February 16, 2010
Last updated: December 7, 2011
Last verified: December 2011
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 16, 2010
Last Updated: December 7, 2011
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 22, 2014