Transvenous Nerve Stimulation for Sleep Apnea
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Respicardia, Inc.
Must not be taking: Muscle relaxants
Disqualifiers: Pregnancy, BMI > 40, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are taking muscle relaxants, you may need approval from the site implanter and ZOLL Respicardia clinical staff to continue.
What data supports the effectiveness of the treatment Transvenous Nerve Stimulation for Sleep Apnea?
Research shows that transvenous phrenic nerve stimulation (TPNS) is effective in treating central sleep apnea, with significant improvements in sleep quality and reduced sleep apnea episodes. In a study, 67% of patients experienced a 50% or greater reduction in sleep apnea events after 12 months of therapy, and improvements in quality of life were sustained.
12345Is transvenous phrenic nerve stimulation safe for humans?
Transvenous phrenic nerve stimulation, used in the remedē System for treating central sleep apnea, has been shown to be generally safe in humans, with a serious adverse event occurring in 9% of patients within 12 months. The system has been approved by the FDA, and long-term safety data up to five years post-implant have been collected.
12346How does transvenous nerve stimulation differ from other treatments for sleep apnea?
Transvenous nerve stimulation (TPNS) is unique because it involves implanting a device that stimulates the phrenic nerve to activate the diaphragm, improving breathing during sleep. This approach is different from other treatments like CPAP machines, which use air pressure to keep airways open, as TPNS directly targets the nerve controlling breathing.
12346Eligibility Criteria
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.Inclusion Criteria
I am getting a new device implanted to help with severe sleep apnea or heart rhythm.
I am 18 years old or older.
Subject is willing and able to give informed consent
Exclusion Criteria
Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
I've had surgery in my mouth that could affect my breathing.
I have weakness or paralysis affecting my nerves, including my tongue.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Procedure
Participants undergo a commercial remedē® System or transvenous cardiac device implant procedure to assess changes in respiration and airway physiology
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after the procedure
4 weeks
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Transvenous nerve stimulationExperimental Treatment1 Intervention
Transvenous nerve stimulation is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as remedē System for:
- Central Sleep Apnea (CSA)
🇪🇺 Approved in European Union as remedē System for:
- Central Sleep Apnea (CSA)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novant Health Forsyth Medical CenterWinston-Salem, NC
The Ohio State University Wexner Medical CenterColumbus, OH
Bryn Mawr Medical Specialists AssociationBryn Mawr, PA
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Who Is Running the Clinical Trial?
Respicardia, Inc.Lead Sponsor
References
Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. [2023]The remedē System Pivotal Trial was a prospective, multi-center, randomized trial demonstrating transvenous phrenic nerve stimulation (TPNS) therapy is safe and effectively treats central sleep apnea (CSA) and improves sleep architecture and daytime sleepiness. Subsequently, the remedē System was approved by FDA in 2017. As a condition of approval, the Post Approval Study (PAS) collected clinical evidence regarding long-term safety and effectiveness in adults with moderate to severe CSA through five years post implant.
Sustained 12 Month Benefit of Phrenic Nerve Stimulation for Central Sleep Apnea. [2019]Transvenous phrenic nerve stimulation improved sleep metrics and quality of life after 6 months versus control in the remedē System Pivotal Trial. This analysis explored the effectiveness of phrenic nerve stimulation in patients with central sleep apnea after 12 months of therapy. Reproducibility of treatment effect was assessed in the former control group in whom the implanted device was initially inactive for the sixth month and subsequently activated when the randomized control assessments were complete. Patients with moderate-to-severe central sleep apnea implanted with the remedē System were randomized to therapy activation at 1 month (treatment) or after 6 months (control). Sleep indices were assessed from baseline to 12 months in the treatment group and from 6 to 12 months in former controls. In the treatment group, a ≥50% reduction in apnea-hypopnea index occurred in 60% of patients at 6 months (95% confidence interval [CI] 47% to 64%) and 67% (95% CI 53% to 78%) at 12 months. After 6 months of therapy, 55% of former controls (95% CI 43% to 67%) achieved ≥50%reduction in apnea-hypopnea index. Patient Global Assessment was markedly ormoderately improved at 6 and 12 months in 60% of treatment patients.Improvements persisted at 12 months. A serious adverse event within 12 months occurred in 13 patients (9%). Phrenic nerve stimulation produced sustained improvements in sleep indices and quality of life to at least 12 months in patients with central sleep apnea. The similar improvement of former controls after 6 months of active therapy confirms benefits are reproducible and reliable.
Transvenous phrenic nerve stimulation for central sleep apnea is safe and effective in patients with concomitant cardiac devices. [2021]Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs).
First interventional exchange of a left transvenous phrenic nerve stimulation lead from the novel remedē system. [2021]The remedē system is a novel fully implantable transvenous phrenic nerve stimulation (TPNS) device developed to treat central sleep apnea. No information is published on how to explant or replace its leads. An eighty-one year-old had a fractured lead and we removed it over a wire. However, unbreachable resistances occurred with a new lead deployed over the enclosed wire and interventional endovascular techniques were performed to reimplant a new fully functioning system. This first report demonstrates TPNS lead exchange is possible but can be challenging. Interventional maneuvers and techniques, including balloon angioplasty, can facilitate this procedure.
Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea: A Pooled Cohort Analysis. [2023]Early evidence with transvenous phrenic nerve stimulation (PNS) demonstrates improved disease severity and quality of life (QOL) in patients with central sleep apnea (CSA). The goal of this analysis is to evaluate the complete prospective experience with PNS in order to better characterize its efficacy and safety, including in patients with concomitant heart failure (HF).
Meta-analysis of Usefulness of Phrenic Nerve Stimulation in Central Sleep Apnea. [2020]Transvenous neurostimulation of the phrenic nerve (PNS) is a potentially improved and unique approach to the treatment of central sleep apnea (CSA). There have been multiple studies with limited individuals evaluating the efficacy of PNS. Our aim was to review and pool those studies to better understand whether phrenic nerve stimulation is efficacious in the treatment of CSA. The initial search on Pubmed retrieved a total of 97 articles and after screening all articles, only 5 could be included in our quantitative analysis. Pooling of data from 5 studies with a total of 204 patients demonstrated a reduction of mean apnea hypopnea index with PNS compared to controls by -26.7 events/hour with 95% confidence interval and P value of [CI (-31.99, -21.46), I2 85, p 0.00]. The mean difference in central apnea index was -22.47 [CI (-25.19, -19.76), I2 0, p 0.00]. The mean reduction in the oxygen desaturation index of 4% or more demonstrated a decrease in PNS group by -24.16 events/hour [(CI -26.20, -22.12), I2 0, p 0.00] compared with controls. PNS resulted in mean reduction in arousal index of -13.77 [CI (-16.15, -11.40), I2 0, p 0.00]. The mean change in percent of time spent in rapid eye movement sleep demonstrated a nonsignificant increase in PNS group by 1.01 % [CI (-5.67, 7.86), I293, p 0.75]. In conclusion, PNS therapy for treating CSA demonstrated positive outcomes but larger randomized studies are needed to evaluate the safety and clinical outcomes.