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Muscle Stimulation for Obstructive Sleep Apnea
N/A
Waitlist Available
Led By David T. Kent, MD
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
A diagnosis of obstructive sleep apnea as determined by polysomnogram with an apnea-hypopnea index of ≥ 5.0/hr.
Adult patient (≥18 years old)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during operative procedure, taking about 15 minutes.
Awards & highlights
Study Summary
This trial will study the effects of two different types of muscle stimulation on the upper airway during sleep.
Who is the study for?
This trial is for adults over 18 with obstructive sleep apnea, confirmed by a sleep study, who can't use CPAP machines comfortably. They must be scheduled for DISE to check their throat structure and agree to research consent. Excluded are those with certain neurological conditions, language barriers, egg allergies, pregnancy, unsafe conditions for sedation or past head/neck surgery or radiation.Check my eligibility
What is being tested?
The study tests the effects of stimulating two muscles in the throat using a Grass S88 Muscle Stimulator during drug-induced sleep endoscopy (DISE). It aims to understand how this stimulation affects airway collapse patterns related to obstructive sleep apnea.See study design
What are the potential side effects?
While specific side effects aren't listed here, muscle stimulators may cause discomfort at the stimulation site, twitching muscles during application and potential skin irritation from electrode placement.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with sleep apnea with an AHI of 5 or more.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected during operative procedure, taking about 15 minutes.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during operative 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
Basic physiologic measurements
Secondary outcome measures
Amount of current needed for adequate stimulation
Trial Design
1Treatment groups
Experimental Treatment
Group I: Muscle stimulationExperimental Treatment1 Intervention
Consented participants who meet eligibility will have a drug induced sleep endoscopy (DISE) and the Grass S88 muscle stimulator.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,132 Total Patients Enrolled
David T. Kent, MDPrincipal InvestigatorVanderbilt University Medical Center
3 Previous Clinical Trials
210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an allergic reaction to eggs in the past.I have been diagnosed with sleep apnea with an AHI of 5 or more.I am scheduled for a throat examination to assess its structure.I am 18 years old or older.My health allows for safe sedation with propofol according to a pre-surgery check.I cannot use CPAP therapy because it's physically or emotionally uncomfortable.I have had surgery on my throat or tonsils.I have had radiation treatment to my head or neck.
Research Study Groups:
This trial has the following groups:- Group 1: Muscle stimulation
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 enrollment available at this time for participants of this clinical trial?
"This research is not presently recruiting, as indicated on clinicaltrials.gov. It was initially posted in July of 2018 and underwent its last update at the end of October 2022. However, 234 other trials are actively seeking participants now."
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