Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM

Vanderbilt University Medical Center

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: High-resolution pharyngeal manometry catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03198416

170755

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Investigational Device

Experimental group

Description:

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

Treatment:

Device: High-resolution pharyngeal manometry catheter