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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)
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during operative procedure, taking about 15 minutes.
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with sleep apnea with an AHI of 5 or more.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My health allows for safe sedation with propofol according to a pre-surgery check.
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I have had surgery on my throat or tonsils.
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I have had radiation treatment to my head or neck.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during operative procedure, taking about 15 minutes.
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during operative procedure, taking about 15 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Basic physiologic measurements
Secondary study objectives
Amount of current needed for adequate stimulation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,441 Total Patients Enrolled
David T. Kent, MDPrincipal InvestigatorVanderbilt University Medical Center
3 Previous Clinical Trials
210 Total Patients Enrolled

Media Library

Grass S88 Muscle Stimulator Clinical Trial Eligibility Overview. Trial Name: NCT03589846 — N/A
Obstructive Sleep Apnea Research Study Groups: Muscle stimulation
Obstructive Sleep Apnea Clinical Trial 2023: Grass S88 Muscle Stimulator Highlights & Side Effects. Trial Name: NCT03589846 — N/A
Grass S88 Muscle Stimulator 2023 Treatment Timeline for Medical Study. Trial Name: NCT03589846 — N/A
~0 spots leftby Dec 2024
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