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This is a single-arm study involving the use of a high resolution manometry (HRM) diagnostic device that is not utilized in any clinical decision-making processes. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via described inclusion and exclusion criteria.
High-resolution pharyngeal manometry (HRM) is a diagnostic technique that has the potential to objectively measure pharyngeal collapse patterns in obstructive sleep apnea (OSA) during sedation as well as natural sleep. The purpose of this study is to assess the utility of HRM in objectively mapping patterns of pharyngeal collapse observed during drug-induced sleep endoscopy (DISE). Quantifying pharyngeal collapse patterns that occur during sedation and in natural sleep may significantly impact the selection and success of surgical treatments, as well as surgical outcome assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device | Experimental | Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution pharyngeal manometry catheter | Device | The system is a widely-used tool in gastrointestinal medicine for high resolution mapping of pressures within tubular organs.The device will be deployed trans-nasally into the pharyngeal and esophageal lumen in exactly the same fashion as is done for motility studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharyngeal pressure differentials | A high-resolution pharyngeal manometry catheter will be used to capture air pressure data in millimeters of mercury at 0.8mm intervals throughout the pharynx and proximal esophagus during the drug-induced sleep endoscopy procedure. This data will be used to generate maps of pressure data over time. | Collected during operative procedure, taking about 15 minutes. |
| Video endoscopy of pharyngeal collapse | Video from the flexible nasopharyngoscopy exam conducted during the drug-induced sleep endoscopy will be recorded and time-synched to the high-resolution pharyngeal manometry catheter output. The video results will be graded by a trained reviewer using a validated scoring system called the VOTE classification. The VOTE system is a subjective scoring system based on video endoscopy that scores the degree and configuration of airway obstruction related to the velum (soft palate), oropharyngeal lateral walls, tongue base, and epiglottis. The VOTE classification results will be compared to the pressure catheter results to examine for correlations. | Collected during operative procedure, the video endoscopy will take about 15 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient tolerance of catheter | Patient comfort as indicated by pre operative pain survey | Completed pre-operatively, after catheter insertion, taking less than 5 minutes. |
| Patient tolerance of catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David T. Kent, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36939475 | Derived | Kent DT, Scott WC, Ye C, Fabbri D. Objective Pharyngeal Phenotyping in Obstructive Sleep Apnea With High-Resolution Manometry. Otolaryngol Head Neck Surg. 2023 Jul;169(1):164-175. doi: 10.1002/ohn.257. Epub 2023 Jan 29. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.
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|
Patient comfort as indicated by post operative pain survey
| Completed at follow up visit about 1 week post-operative, taking less than 5 minutes. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |