Muscle Stimulation During DISE
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | July 26, 2018 |
| End Date: | December 2020 |
The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
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.
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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