LivaNova Plc has announced favorable results from its OSPREY randomized controlled trial (RCT), which studied the effectiveness of its aura6000 System for treating moderate to severe obstructive sleep apnea (OSA). The findings, published in the Annals of Internal Medicine, highlight the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a unique neurostimulation technique, over a 12-month period.
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The study reported clinically significant improvements in several key metrics, including the apnea-hypopnea index (AHI), sleep quality, and patient-reported outcomes (PROs), showing that the benefits began at month seven and were sustained through month thirteen. LivaNova had previously shared top-line results from the OSPREY trial in May 2025.
Dr. Atul Malhotra, lead investigator and sleep medicine expert at the University of California – San Diego, emphasized that OSPREY was designed to include a diverse demographic and a broader range of OSA severity than previous studies, addressing a critical gap in the evidence base. He noted the findings demonstrate significant improvements in both the objective severity of OSA and related factors like daytime sleepiness.
The OSPREY study, titled "Proximal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: The OSPREY Study: A Randomized Controlled Trial," involved 104 adults and compared outcomes between those receiving pHGNS and a control group. Participants in the treatment cohort reported marked improvements in assessments such as the Clinical Global Impression–Improvement (CGI-I) scale and questionnaires measuring daytime sleepiness and the impact of fatigue on daily activities.
Results showed that 69% of treated subjects achieved at least a 25% reduction in the oxygen desaturation index (ODI) at month seven compared to 38% in the control group. Additionally, the median AHI significantly decreased from 34.3 events/hour at baseline to 11.6 events/hour at month seven for the treatment group. At month thirteen, AHI improved further, with the treatment group averaging 11.0 events/hour and the control group at 20.9 events/hour.
LivaNova reported that treatment-related adverse events were mostly mild or moderate, with headaches, implant site pain, and swallowing difficulties being the most common. The results indicated a significant decline in sleep arousals, with the treatment group experiencing a reduction from 55/hour at baseline to 29/hour by month thirteen.
Ahmet Tezel, LivaNova's Chief Innovation Officer, praised the study’s rigor and highlighted the potential of pHGNS technology to reach a wider range of patients compared to previous studies. LivaNova received FDA premarket approval for the aura6000 System, which is designed for patients who are intolerant of conventional therapies like positive airway pressure (PAP).
The findings from the OSPREY trial support LivaNova's aim to expand access to this alternative therapy for OSA, which affects up to one billion people globally. The company is also preparing a next-generation OSA device for FDA approval, which aims to enhance compatibility with MRI and feature improved battery life and management capabilities.