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OpenTrials
Completed

NCT Number: NCT01069068

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr John Viviano and Associates

Mississauga, Ontario, L5L3P9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

    Time frame: one 60 minute session

Secondary outcomes

  1. Assessment of the habitual mandibular position in (edge-to-edge, millimetres) relation to the front upper teeth

    Time frame: one 60 minute session

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Doctor's Directive Strategies Inc.

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2010
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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