Obstructive Sleep Apnea
Conditions
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.
Interventions
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).
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Basic physiologic measurements | Collected during operative procedure, taking about 15 minutes. | This study involves the collection of basic physiologic measurements (airway cross-sectional diameter with and without muscle stimulation) during a single session of DISE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amount of current needed for adequate stimulation | Collected during operative procedure, taking about 15 minutes. | Obtain preliminary data regarding including the amount of current needed to adequately stimulate the palatoglossus muscle. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid T. Kent, MD
Vanderbilt University Medical Center
Outcome results
None listed