An interventional study of High-resolution pharyngeal manometry catheter in Obstructive Sleep Apnea, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-26.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Device feasibility
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 965 interventional studies indexed under Apnea.
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Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system.
Device: High-resolution pharyngeal manometry catheter
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.
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.
Time frame: 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.
Time frame: Collected during operative procedure, the video endoscopy will take about 15 minutes.
Patient tolerance of catheter
Patient comfort as indicated by pre operative pain survey
Time frame: Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
Patient tolerance of catheter
Patient comfort as indicated by post operative pain survey
Time frame: Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center