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

Doctor's Directive Strategies

Status: Completed

Conditions: Obstructive Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT01069068

RDD-2009-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.