Muscle Stimulation During DISE

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Grass S88 Muscle Stimulator


Participation Criteria
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Eligibility Criteria
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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 CPAP therapy due to physical or psychosocial limitations as determined by clinical history Scheduled to undergo DISE as part of routine clinical assessment for further evaluation of pharyngeal anatomy Exclusion Criteria: Unable to consent for research due to a pre-existing neurologic condition as determined by PI Unable to consent for research due to language barriers A history of egg allergy as determined by history or self-reports Currently pregnant as determined by patient report or pre-operative anesthesia evaluation Cardiopulmonary or other medical conditions precluding safe propofol sedation as determined by pre-operative anesthesia evaluation History of palatal or pharyngeal airway surgery including tonsillectomy as determined by clinical history and exam History of radiation treatment to the head or neck as determined by history and/or physical exam

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle stimulation<br>Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator. | Device: Grass S88 Muscle Stimulator<br>* The Grass S88 nerve and muscle stimulator is a widely-used tool in electromyography and nerve conduction studies. Under anesthesia, fine-wire electrodes will be placed into the right genioglossus muscle (in the floor of the mouth) and the right palatoglossus muscle (in the anterior tonsillar pillar).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic physiologic measurements | This study involves the collection of basic physiologic measurements (airway cross-sectional diameter with and without muscle stimulation) during a single session of DISE. | Collected during operative procedure, taking about 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of current needed for adequate stimulation | Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle. | Collected during operative procedure, taking about 15 minutes. |