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Neurostimulation

Nerve Stimulation for Obstructive Sleep Apnea

N/A
Recruiting
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
Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during dise, approximately 15 minutes
Awards & highlights

Study Summary

This trial will assess the effects of ACS and HNS therapy on OSA severity and airway collapse patterns in patients with OSA.

Who is the study for?
This trial is for consenting adults with a BMI between 25 and 40, diagnosed with moderate to severe obstructive sleep apnea (OSA), characterized by an AHI of 20-80 events/hr. It's not suitable for those with neurostimulation devices, chronic opiate use, alcohol dependency, other sleep disorders, significant cardiopulmonary disease or history of upper airway surgery.Check my eligibility
What is being tested?
The study tests the effects of ansa cervicalis stimulation (ACS) alone and combined with hypoglossal nerve stimulation (HNS) on OSA. Participants will undergo polysomnography and drug-induced sleep endoscopy to assess the impact on their upper airway during sleep.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, temporary changes in voice or swallowing due to nerve activation. There might also be risks associated with sedation required for endoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have sleep apnea with 20-80 breathing pauses per hour, mostly obstructive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during dise, approximately 15 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during dise, approximately 15 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abortion, Drug-Induced
Endoscopy (procedure)
Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data
+8 more
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 second sleep study and the Grass S88 (or comparable) muscle stimulator.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,057 Total Patients Enrolled
David T. Kent, MDPrincipal InvestigatorVanderbilt University Medical Center
3 Previous Clinical Trials
170 Total Patients Enrolled

Media Library

Grass S88 Muscle Stimulator (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05501236 — 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: NCT05501236 — N/A
Grass S88 Muscle Stimulator (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501236 — N/A
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT05501236 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has been recruited for this experiment?

"Yes, according to clinicaltrials.gov's data, the research project is still accepting participants since its initial posting on November 4th 2022 and most recent edit 8 days later. The trial requires 100 individuals across one medical centre."

Answered by AI

Are there currently any openings to participate in this clinical experiment?

"The medical trial, initially announced on November 4th 2022 and revised shortly after, is actively recruiting patients according to the information found on clinicaltrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

30 year history of snoring. I have had issues with sleep since my early 30s .
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Is there monetary compensation?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA
David Kent 2022. "Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501236.
~60 spots leftby May 2026
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