What this study is
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.
What's being tested
- Grass S88 Muscle Stimulator
Intervention · DEVICE
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).
Study details
- Official title
- The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Obstructive Sleep Apnea
- Enrolling
- 60 people
- Starts
- 2018-07-26
- Est. completion
- 2028-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University Medical Center
Nashvile, Tennessee, United States
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 181078
Principal investigator
David T. Kent, MD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.