Dual Channel Stimulation for Sleep Apnea

Recruiting at 2 trial locations

Overseen By Kathy McPherson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zoll Medical Corporation

Disqualifiers: Severe COPD, Bipolar, Kidney dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new device, the remedē® Dual Channel System, to determine its safety and effectiveness for people with severe sleep apnea, a condition that disrupts breathing during sleep. The researchers aim to evaluate the device's performance in sleep studies and ensure its long-term safety. Individuals with severe sleep-disordered breathing, who either do not have heart failure or have medically stable heart failure, may be suitable candidates for this trial. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research that could enhance sleep apnea treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the remedē® Dual Channel System is safe for sleep apnea?

Research has shown that the remedē® Dual Channel System is safe for use. A major study found that it met all safety standards, proving it both safe and effective. Over five years, this system improved sleep quality with minimal risks. Another study during the same period confirmed these results, demonstrating the device's continued safety and effectiveness for treating moderate to severe central sleep apnea. These findings suggest that the remedē® Dual Channel System is well-tolerated, with few side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The remedē® Dual Channel System is unique because it offers a new approach to treating sleep apnea by using a dual-channel stimulation method. Most current treatments, like CPAP machines or oral appliances, focus on mechanically keeping airways open during sleep. In contrast, the remedē® system works by stimulating the phrenic nerve to help regulate breathing patterns naturally. Researchers are excited about this system because it has the potential to improve patient compliance and comfort compared to traditional treatments, offering a more physiological solution to managing sleep apnea.

What evidence suggests that the remedē® Dual Channel System is effective for sleep apnea?

Studies have shown that the remedē® Dual Channel System, which participants in this trial will receive, greatly helps people with sleep apnea. Research indicates it reduces the Central Apnea Index, which measures how often breathing stops during sleep, by 96%. Additionally, 88% of patients experienced a decrease in their Apnea-Hypopnea Index (AHI), a measure of sleep apnea severity. Long-term data shows these benefits last for up to five years, with no new safety concerns. Overall, this system improves sleep quality with minimal risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Robin Germany, MD

Principal Investigator

ZOLL Respicardia

Are You a Good Fit for This Trial?

This trial is for individuals with severe sleep disordered breathing who can tolerate the study procedures. It's suitable for those without heart failure or with medically stable heart failure.

Inclusion Criteria

I can handle the procedures involved in the study.

I have severe problems with my breathing while I sleep.

I do not have heart failure or it is medically managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Successful implantation of the remedē® Dual Channel System

1 day

Treatment

Participants undergo overnight sleep studies to evaluate the remedē® Dual Channel System

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• remedē® Dual Channel System

Trial Overview The Janus II Feasibility study is testing the remedē® Dual Channel System, focusing on its feasibility during implantation and overnight sleep studies, as well as assessing its long-term safety.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zoll Medical Corporation

Lead Sponsor

Trials

48

Recruited

23,100+

Citations

1. remede.zoll.com remede.zoll.com/clinicians/study-results/

remedē® study results | Clinical evidence Reduction in Sleep Disturbances · 96% reduction in Central Apnea Index · 88% of patients experienced a reduction in AHI · Significant reduction in oxygen ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6802564/

Long-term efficacy and safety of phrenic nerve stimulation for ... These data suggest beneficial effects of long-term PNS in patients with CSA appear to sustain through 36 months with no new safety concerns.

3. sleeplessinarizona.com sleeplessinarizona.com/remede-maintains-safety-and-effectiveness-over-5-years/

Remedē Maintains Safety and Effectiveness Over 5 Years A five-year study confirms the Remedē System's safety and effectiveness, improving sleep quality with minimal risks.

4. aasm.org aasm.org/fda-approves-remede-implantable-device-treat-central-sleep-apnea/

FDA approves Remedē implantable device to treat central ... After six months, AHI was reduced by 50 percent or more in 51 percent of patients with an active Remedē System implanted. AHI was reduced by 11 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03884660

NCT03884660 | remedē System Therapy Study The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6607512/

Phrenic nerve stimulation to treat patients with central sleep ... Phrenic nerve stimulation reduces CSA severity in patients with HF. In parallel, this CSA treatment was associated with benefits on HF quality of life.

7. respiratory-therapy.com respiratory-therapy.com/products-treatment/monitoring-treatment/therapy-devices/five-year-study-zoll-remede-system/

Five-year Study Confirms Safety of Zoll Remedē System Five-year data on the Zoll remedē System showed sustained safety and efficacy for the treatment of moderate to severe central sleep apnea.