Clinical trial NCT03198416: Pharyngeal Anatomy In Obstructive Sleep Apnea With HRM
Official title: Assessment Of Pharyngeal Anatomy In Obstructive Sleep Apnea With High Resolution Manometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients who meet eligiblity will undergo HRM at the same time as the operative DISE procedure.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pharyngeal pressure differentials
timeFrame: Collected during operative procedure, taking about 15 minutes.
measure: Video endoscopy of pharyngeal collapse
timeFrame: Collected during operative procedure, the video endoscopy will take about 15 minutes.
Secondary outcomes:
measure: Patient tolerance of catheter
timeFrame: Completed pre-operatively, after catheter insertion, taking less than 5 minutes.
measure: Patient tolerance of catheter
timeFrame: Completed at follow up visit about 1 week post-operative, taking less than 5 minutes.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: David T. Kent, MD
role: PRINCIPAL_INVESTIGATOR
References: