Muscle Stimulation During DISE
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obstructive Sleep Apnea
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All patients who meet eligiblity will undergo muscle stimulation at the same time as the operative DISE procedure.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03589846
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David T. Kent, MD Vanderbilt University Medical Center
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