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

NCT01069068 | Completed

• 1 other identifier: RDD-2009-001
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

To evaluate the effect of advancing Jaw on airway dimension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doctor's Directive Strategies Inc.: lead

Study Sites (1)

Dr John Viviano and Associates

Mississauga, Ontario, L5L3P9, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• John S Viviano, DDS

  Dr John Viviano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

CA (1)