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Completed

NCT Number: NCT03198416

Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-resolution pharyngeal manometry catheter

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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