Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: High-resolution pharyngeal manometry catheter

• Registration Number: NCT03198416
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2017-12-11
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patient (≥18 years old)
• A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr
• Intolerant of continuous positive airway pressure (CPAP) therapy due to physical or psychosocial limitations as determined by PI
• Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy

Read More

Exclusion Criteria

• Patient is unable to consent for research due to a pre-existing neurologic condition as determined by PI
• Patient is unable to consent for research due to language barriers
• Patient has a history of egg allergy as determined by history or self- report
• Patient is pregnant as determined by patient report or preoperative anesthesia evaluation
• Cardiopulmonary or other medical conditions precluding safe sedation as determined by clinical history and exam
• History of palatal or pharyngeal airway surgery except tonsillectomy as determined by clinical history and exam
• History of radiation treatment to the head or neck as determined by clinical history and/or exam
• Severe nasal airway obstruction preventing simultaneous flexible nasopharyngoscopy and manometry probe insertion as determined by physical exam

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Device	High-resolution pharyngeal manometry catheter	Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system.

Primary Outcome Measures

Name	Time	Method
Pharyngeal pressure differentials	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	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.

Secondary Outcome Measures

Name	Time	Method
Patient tolerance of catheter	Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.	Patient comfort as indicated by post operative pain survey

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States