Sleep Apnea, Obstructive
Conditions
Keywords
OSA
Brief summary
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.
Detailed description
The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate
Interventions
DIAGNOSTIC_TESTPharyngeal width measurement
A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth
Sponsors
Inspire Medical Systems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient meets the indications for the Inspire Upper Airway Stimulation * Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.
Exclusion criteria
* Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement * Any other reason the investigator deems that the patient is unfit for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy | Baseline, prior to routine diagnostic drug induced sleep endoscopy | Pharyngeal width will be measured in millimeters using a caliper |
Countries
United States
Contacts
Primary ContactAnna N Bader
Backup ContactMike Swierzewski
Outcome results
None listed