Muscle Stimulation During DISE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Grass S88 Muscle Stimulator.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Palatoglossus and Genioglossus Stimulation During Drug-Induced Sleep Endoscopy
Overview
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
- Device Grass S88 Muscle Stimulator
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).
Primary outcome measures
- Basic physiologic measurements [Time frame: Collected during operative procedure, taking about 15 minutes.]
Secondary outcome measures (1)
- Amount of current needed for adequate stimulation [Time frame: Collected during operative procedure, taking about 15 minutes.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashvile
Identifiers
NCT: NCT03589846 · 181078