Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

NCT03198416 | Completed FDA Device

• 1 other identifier: 170755
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• Patient tolerance of catheter

  Completed pre-operatively, after catheter insertion, taking less than 5 minutes.

• Patient tolerance of catheter

  Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.

Study Arms (1)

Investigational Device

EXPERIMENTAL

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

Interventions

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.

Investigational Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Kent DT, Scott WC, Ye C, Fabbri D. Objective Pharyngeal Phenotyping in Obstructive Sleep Apnea With High-Resolution Manometry. Otolaryngol Head Neck Surg. 2023 Jul;169(1):164-175. doi: 10.1002/ohn.257. Epub 2023 Jan 29.

  PMID: 36939475 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• David T. Kent, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Otolaryngology

Model Details: All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 26, 2017
• Study Start: December 11, 2017
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

US (1)