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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
Must not have
Subject has had prior oral cavity surgery that may interfere with breathing
Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure (immediately post-stimulation)
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
Select...
I am getting a new device implanted to help with severe sleep apnea or heart rhythm.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've had surgery in my mouth that could affect my breathing.
Select...
I have weakness or paralysis affecting my nerves, including my tongue.
Select...
I have had surgery on my neck before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure (immediately post-stimulation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure (immediately post-stimulation) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in respiration and airway physiology

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: 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

Transvenous nerve stimulation (Nerve Stimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT03985527 — N/A
Sleep Apnea Research Study Groups: Transvenous nerve stimulation
Sleep Apnea Clinical Trial 2023: Transvenous nerve stimulation Highlights & Side Effects. Trial Name: NCT03985527 — N/A
Transvenous nerve stimulation (Nerve Stimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03985527 — N/A
~2 spots leftby Mar 2025
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