Clinical trial NCT03589846: Muscle Stimulation During DISE
Official title: The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-07-18
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 muscle stimulation at the same time as the operative DISE procedure.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Drug-induced sleep endoscopy (DISE) is a widely used tool for assessing collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. We propose a study examining the physiologic effect of palatoglossus and genioglossus muscle stimulation during DISE.

Detailed description: This is a single-arm study involving the use of a diagnostic device (muscle stimulator) that is not currently utilized in any clinical decision-making processes for OSA patients. All patients scheduled for DISE as part of their regular clinical care will be screened for enrollment via the previously described inclusion and exclusion criteria. The study is not blinded. No diagnostic information collected from muscle stimulation will be used in clinical decision-making processes.

Eligibility criteria: Inclusion Criteria:

1. Adult patient (≥18 years old)
2. A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr.
3. Intolerant of CPAP therapy due to physical or psychosocial limitations as determined by clinical history
4. Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy

Exclusion Criteria:

1. Unable to consent for research due to a pre-existing neurologic condition as determined by PI
2. Unable to consent for research due to language barriers
3. A history of egg allergy as determined by history or self-reports
4. Currently pregnant as determined by patient report or pre-operative anesthesia evaluation
5. Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation
6. History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam
7. History of radiation treatment to the head or neck as determined by history and/or physical exam

Primary outcomes:
measure: Basic physiologic measurements
timeFrame: Collected during operative procedure, taking about 15 minutes.
Secondary outcomes:
measure: Amount of current needed for adequate stimulation
timeFrame: Collected during operative procedure, taking about 15 minutes.
Other outcomes:
Locations:
city: Nashvile
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: