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Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03198416
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : July 22, 2019
Information provided by (Responsible Party):
David Kent, 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: High-resolution pharyngeal manometry catheter Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Sleep Apnea

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03198416

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Contact: Kate Von Wahlde, MJ, CCRP 615-322-0333

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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kate Von Wahlde, MJ, CCRP    615-322-0333   
Principal Investigator: David T. Kent, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
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Principal Investigator: David T. Kent, MD Vanderbilt University Medical Center

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Responsible Party: David Kent, Assistant Professor, Department of Otolaryngology, Vanderbilt University Medical Center Identifier: NCT03198416     History of Changes
Other Study ID Numbers: 170755
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases