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Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-resolution pharyngeal manometry catheter
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Device

Arm Description

Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Patient tolerance of catheter
Patient comfort as indicated by pre operative pain survey
Patient tolerance of catheter
Patient comfort as indicated by post operative pain survey

Full Information

First Posted
June 11, 2017
Last Updated
August 21, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03198416
Brief Title
Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM
Official Title
Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device
Arm Type
Experimental
Arm Description
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) with the Solar GI High Resolution pharyngeal Manometry system.
Intervention Type
Device
Intervention Name(s)
High-resolution pharyngeal manometry catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pharyngeal pressure differentials
Description
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.
Title
Video endoscopy of pharyngeal collapse
Description
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.
Secondary Outcome Measure Information:
Title
Patient tolerance of catheter
Description
Patient comfort as indicated by pre operative pain survey
Time Frame
Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
Title
Patient tolerance of catheter
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Von Wahlde, MJ, CCRP
Phone
615-322-0333
Email
kate.vonwahlde@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Kent, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Von Wahlde, MJ, CCRP
Phone
615-322-0333
Email
kate.vonwahlde@vumc.org
First Name & Middle Initial & Last Name & Degree
David T. Kent, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

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