Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

Obstructive Sleep Apnea Clinical Trial

Official title:

Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198416
• Other study ID #: 170755
• Status: Completed
• Phase: N/A
• Start date: December 11, 2017
• Est. completion date: June 24, 2019

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	Patient tolerance of catheter	Patient comfort as indicated by pre operative pain survey	Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
Secondary	Patient tolerance of catheter	Patient comfort as indicated by post operative pain survey	Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.