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Muscle Stimulation During DISE
Muscle Stimulation During DISE
Enrolling By InvitationNA
Sponsor: Vanderbilt University Medical Center
Conditions: Obstructive Sleep Apnea
Interventions: Grass S88 Muscle Stimulator
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
Locations (1)
- Nashvile, Tennessee, United States