LivaNova has reported that 65% of patients receiving active therapy with its investigational aura6000 System responded to treatment after 12 months in the ongoing OSPREY clinical trial for moderate to severe obstructive sleep apnoea (OSA).
A treatment response was defined as a reduction of at least 50% in the apnea-hypopnea index (AHI) and achieving an AHI score below 20.
The aura6000 System, which employs proximal hypoglossal nerve stimulation (p-HGNS), is under clinical investigation as a therapy for patients who do not tolerate or are unwilling to continue with positive airway pressure treatments.
The device uses six electrodes positioned on the proximal segment of the hypoglossal nerve to stimulate airway muscles and maintain airway patency during sleep.
The OSPREY trial is a prospective, multi-centre, randomised controlled open-label study evaluating the safety and efficacy of the aura6000 System against a no-stimulation control.
The study population included adult patients with moderate to severe OSA who were unable to tolerate positive airway pressure devices.
The 12-month data build on earlier six-month results, announced in November 2024, which confirmed that the trial met both primary and secondary endpoints.
Median AHI fell by 68% from a baseline of 34.3 to 11.0, while median oxygen desaturation index (ODI) also declined by 68%, from 34.9 to 11.1. These reductions were sustained over the extended treatment period, demonstrating consistency in therapy performance.
Participants also reported improvement in secondary outcomes, including the Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ), both of which are validated tools used to assess daytime sleepiness and quality of daily functioning.
University of California San Diego School of Medicine professor Atul Malhotra, who is the study’s lead investigator, said: “Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time.
“Responder rates in the treatment group were strong throughout the first year with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark.
“In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.”
There were no serious adverse events related to the aura6000 device or its implantation procedure reported in the trial. The safety record, in combination with consistent reductions in AHI and patient-reported improvements, forms the basis of the ongoing regulatory submission.
LivaNova has submitted a premarket approval application to the US Food and Drug Administration (FDA) based on six-month results. The company has also shared interim 12-month data and plans to provide the full dataset during the review process.
