remedē System for Central Sleep Apnea
(rēST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the safety and effectiveness of the remedē System for individuals with moderate to severe central sleep apnea, a condition where breathing stops and starts during sleep. The remedē System is a device that regulates breathing during sleep. Individuals diagnosed with central sleep apnea through a sleep study may be suitable candidates for this trial. The goal is to collect real-world data on the treatment's performance outside a controlled research setting. As a Phase 3 trial, this represents the final step before FDA approval, providing participants an opportunity to contribute to the validation of a potentially groundbreaking 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 team or your doctor.
What is the safety track record for the remedē System Therapy?
Research shows that the remedē System is safe for use. The FDA has approved it, indicating its safety. Studies have demonstrated that it functions as intended without causing unexpected issues.
Before approval, researchers conducted several studies to assess the safety and effectiveness of the remedē System. These studies examined any side effects from the implant procedure, the device itself, or the therapy it provides. The results were positive, showing that participants generally tolerated the treatment well.
Therefore, for those considering joining a trial with the remedē System, current evidence suggests it is a safe choice.12345Why are researchers enthusiastic about this study treatment?
The remedē System Therapy is unique because it specifically targets central sleep apnea (CSA) by stimulating the phrenic nerve, which controls the diaphragm and helps regulate breathing during sleep. Unlike other treatments, such as CPAP machines that provide continuous airflow, remedē works by activating natural breathing processes, potentially offering a more comfortable and less intrusive solution. Researchers are excited about this therapy because it represents a novel approach that could improve sleep quality and reduce the health risks associated with CSA.
What evidence suggests that the remedē System Therapy is effective for its intended use?
Research has shown that the remedē System effectively treats central sleep apnea. In one study, 51% of patients using the remedē System experienced a 50% reduction in sleep apnea symptoms after six months. Long-term studies have also found that improvements in sleep quality and overall well-being lasted for at least a year. This device controls breathing during sleep by stimulating a nerve that manages breathing and has received FDA approval, underscoring its effectiveness. Overall, the remedē System shows promise in improving sleep and enhancing life quality for those with central sleep apnea.34678
Who Is on the Research Team?
Kathy McPherson
Principal Investigator
ZOLL Respicardia, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Treatment
Participants are implanted with the remedē System and begin therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Extended monitoring of sleep disordered breathing metrics and safety
What Are the Treatments Tested in This Trial?
Interventions
- remedē System Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Respicardia, Inc.
Lead Sponsor
Citations
remedē® study results | Clinical evidence
90% of patients experienced freedom from serious adverse events associated with implant procedure, the remedē System, or delivered therapy at 12 months. 86% ...
Long-term efficacy and safety of phrenic nerve stimulation for ...
Improvements in sleep indices, sleep quality, and quality of life observed in the remedē System Pivotal Trial were sustained through 12 months of active ...
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.
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.
Design of the remedē System Therapy (rēST) study
This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects implanted with the remedē System.
Clinicians Important Safety Information - remedē® System
The remedē® System, remedē® EL System, and remedē® EL-X System have received FDA approval. The remedē® System model 1001 has received CE Mark approval.
summary of safety and effectiveness data (ssed)
Six (6) human clinical studies were completed prior to the start of the remedē System Pivotal. Trial to assess the safety and effectiveness of ...
Design of the remedē System Therapy (rēST) study
Safety objectives include evaluation of adverse events related to the implant procedure, device or delivered therapy, death, and hospitalizations.
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