Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM
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|ClinicalTrials.gov Identifier: NCT03198416|
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: High-resolution pharyngeal manometry catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry|
|Actual Study Start Date :||December 11, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Investigational Device
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 [ Time Frame: Collected during operative procedure, taking about 15 minutes. ]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.
- Video endoscopy of pharyngeal collapse [ Time Frame: Collected during operative procedure, the video endoscopy will take about 15 minutes. ]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.
- Patient tolerance of catheter [ Time Frame: Completed pre-operatively, after catheter insertion, taking less than 5 minutes. ]Patient comfort as indicated by pre operative pain survey
- Patient tolerance of catheter [ Time Frame: Completed at follow up visit about 1 week post-operative, taking less than 5 minutes. ]Patient comfort as indicated by post operative pain survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198416
|Contact: Kate Von Wahlde, MJ, CCRPfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Kate Von Wahlde, MJ, CCRP 615-322-0333 email@example.com|
|Principal Investigator: David T. Kent, MD|
|Principal Investigator:||David T. Kent, MD||Vanderbilt University Medical Center|