Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial

Area of Science:

• Medical Devices
• Neurology
• Pulmonology

Background:

• Central sleep apnoea (CSA) is a severe condition linked to adverse health outcomes.
• The remedé system is an implantable device designed to treat CSA via transvenous neurostimulation.
• This study assesses the safety and efficacy of unilateral neurostimulation for CSA patients.

Purpose of the Study:

• To evaluate the safety and effectiveness of the remedé system for treating central sleep apnoea.
• To compare the reduction in apnoea-hypopnoea index (AHI) in patients receiving neurostimulation versus a control group.
• To assess serious adverse events related to the implantable device and therapy over 12 months.

Main Methods:

• A prospective, multicentre, randomized trial involving 151 patients with moderate to severe CSA.
• Patients were randomized (1:1) to receive either transvenous neurostimulation or no stimulation for 6 months.
• The primary endpoint was achieving a ≥50% reduction in AHI, assessed by polysomnography.

Main Results:

• Significantly more patients in the treatment group (51%) achieved a ≥50% AHI reduction compared to the control group (11%) (p<0.0001).
• The overall rate of serious adverse events related to the system or therapy was low (8% in treatment, 9% in control) at 12 months.
• Non-serious discomfort was reported by 37% of the treatment group, with most resolved by reprogramming.

Conclusions:

• Transvenous neurostimulation using the remedé system is effective in reducing CSA severity.
• The therapy demonstrated clinically meaningful improvements in sleep metrics, oxygenation, and quality of life.
• Transvenous neurostimulation presents a promising therapeutic option for patients suffering from central sleep apnoea.