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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01069068

Enrollment

Registered

2010-02-17

Start date

2010-02-28

Completion date

2010-04-30

Last updated

2011-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

To evaluate the effect of advancing Jaw on airway dimension

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Canada

Outcome results