Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:December 11, 2017
End Date:December 2020
Contact:Kate Von Wahlde, MJ, CCRP
Email:kate.vonwahlde@vumc.org
Phone:615-322-0333

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: David T. Kent, MD
Phone: 615-322-0333
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials