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Nerve Stimulation Device
Transvenous Nerve Stimulation for Sleep Apnea
N/A
Recruiting
Research Sponsored by Respicardia, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
Subject is at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure (immediately post-stimulation)
Awards & highlights
Study Summary
This trial tests if a different implant site for a pacemaker/defibrillator affects breathing/airway during the procedure.
Who is the study for?
This trial is for adults over 18 with moderate to severe central sleep apnea who are getting a new remedē® System or other cardiac device like a pacemaker. They must be able to consent and not have significant upper airway issues, nerve problems affecting the tongue, prior neck surgery, BMI over 40, unstable health conditions, pregnancy plans, dye allergies that can't be managed, past oral cavity surgeries impacting breathing or use muscle relaxants without approval.Check my eligibility
What is being tested?
The Janus Feasibility Study is testing if changing where transvenous leads are placed during implant procedures of devices like the remedē® System affects breathing and airway function in patients with sleep apnea.See study design
What are the potential side effects?
Potential side effects may include discomfort at the lead placement site, possible respiratory changes due to stimulation adjustments and general risks associated with implant procedures such as infection or bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am getting a new device implanted to help with severe sleep apnea or heart rhythm.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure (immediately post-stimulation)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure (immediately post-stimulation)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in respiration and airway physiology
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transvenous nerve stimulationExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Respicardia, Inc.Lead Sponsor
8 Previous Clinical Trials
967 Total Patients Enrolled
3 Trials studying Sleep Apnea
138 Patients Enrolled for Sleep Apnea
Kathy A McPherson, RN, MSNStudy DirectorRespicardia, Inc.
Tim Meyer, MS, PhDStudy DirectorRespicardia, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting a new device implanted to help with severe sleep apnea or heart rhythm.I've had surgery in my mouth that could affect my breathing.I have weakness or paralysis affecting my nerves, including my tongue.You have had a device implanted in your upper airway in the past or currently have one.I am on muscle relaxants, approved by my doctor and the clinical trial staff.You have a major problem with the structure of your upper airway.I am 18 years old or older.I have had surgery on my neck before.You have a very high body mass index (BMI) at the time of the study.I am not fit or willing to follow the study's procedures due to my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Transvenous nerve 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.
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Novant Health Forsyth Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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