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Nerve Stimulation
Nerve Stimulation for Obstructive Sleep Apnea
N/A
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Consenting adults with BMI ≥ 25 and ≤ 40 kg/m2
Planned resection of parapharyngeal space (PPS) mass without clinical evidence of cranial nerve function deficits based on physical examination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during a single dise procedure, taking about 15 minutes.
Awards & highlights
Study Summary
This trial will study the nerve that controls throat muscles to see if electrical stimulation can help keep the airway open to improve breathing.
Who is the study for?
This trial is for consenting adults with a BMI between 25 and 40 who have moderate-to-severe Obstructive Sleep Apnea or are at high risk based on STOP-BANG criteria. Participants must be planning to undergo surgery for a parapharyngeal space mass without nerve function issues.Check my eligibility
What is being tested?
The study tests how stimulating the glossopharyngeal nerve affects muscle control and airway openness during surgery in patients with sleep apnea. It involves using a special device and electrode to apply electrical stimulation.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, temporary changes in sensation or taste, gagging, or difficulty swallowing due to nerve stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 25 and 40.
Select...
I am scheduled for surgery to remove a neck mass and have no issues with nerve function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected during a single dise procedure, taking about 15 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during a single dise procedure, taking about 15 minutes.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in variation in the conformation of the glossopharyngeal nerve
Secondary outcome measures
Change in Airway cross-sectional diameter
Change in airflow
Change in respiratory effort
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Surgical ProcedureExperimental Treatment1 Intervention
Consented patients who meet eligibility will have a surgical procedure for management of head and neck cancer, with dissection and exposure of the relevant anatomic structures as part of regular clinical care.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,142 Total Patients Enrolled
David T. KentStudy DirectorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical device implanted in your body to help with nerve stimulation, like a pacemaker or nerve stimulator.I have had chemoradiation therapy for head or neck cancer.My BMI is between 25 and 40.I have had surgery in my throat area, but not for removing tonsils.I have been diagnosed with severe sleep apnea or am at high risk based on a test.I have been diagnosed with a sleep-related breathing disorder other than obstructive sleep apnea.I am scheduled for surgery to remove a neck mass and have no issues with nerve function.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment recruiting test subjects currently?
"Clinicaltrials.gov does not indicate that this trial is actively enrolling participants at this moment. The study was originally made public on July 1st 2023, and the last alteration to its information was conducted on April 21st 2023. Nonetheless, 517 other trials are currently accepting patients into their studies."
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