Annals of Internal Medicine Reports One-Year Findings from LivaNova’s OSPREY Clinical Trial in Obstructive Sleep Apnea
LivaNova PLC (Nasdaq: LIVN) has announced the publication of comprehensive 12-month results from its landmark OSPREY randomized controlled trial (RCT) in the prestigious Annals of Internal Medicine, marking a significant advancement in the clinical understanding of neurostimulation therapies for obstructive sleep apnea (OSA). The study evaluated the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), delivered באמצעות LivaNova’s proprietary aura6000™ System, in adults suffering from moderate to severe forms of the disorder.
The publication provides one of the most rigorous and complete datasets to date for hypoglossal nerve stimulation, demonstrating clinically meaningful and sustained improvements in multiple key endpoints. These include reductions in apnea-hypopnea index (AHI), improvements in sleep quality, and significant gains in patient-reported outcomes (PROs). The findings build upon topline 12-month data previously disclosed by LivaNova in May 2025, offering deeper insights into both objective and subjective benefits associated with the therapy.
Obstructive sleep apnea is a widespread yet underdiagnosed condition characterized by repeated interruptions in breathing during sleep due to airway collapse. These interruptions can lead to fragmented sleep, reduced oxygen levels, and a host of downstream health complications, including cardiovascular disease, cognitive impairment, and diminished quality of life. Despite the availability of standard treatments such as positive airway pressure (PAP) therapy, many patients struggle with adherence, creating a substantial unmet need for alternative therapeutic options.
The OSPREY study was specifically designed to address longstanding limitations in the evidence base for hypoglossal nerve stimulation. According to Atul Malhotra, the study’s lead investigator and a professor at the University of California San Diego School of Medicine, prior research in this area has often relied on small, highly selective case series. Such studies, while informative, have not adequately captured the diversity of patients encountered in routine clinical practice.
In contrast, OSPREY enrolled a broader and more representative patient population, including individuals with varying degrees of OSA severity, higher body mass index (BMI), and even those with complete concentric collapse (CCC)—a subgroup often excluded from earlier trials. By incorporating both objective clinical endpoints and a range of subjective patient-reported measures, the study provides a more holistic assessment of therapeutic impact.
At its core, the investigation explored pHGNS as a viable alternative for adult patients who are intolerant of PAP therapy. The technology works by stimulating the hypoglossal nerve, which controls tongue movement and plays a critical role in maintaining airway patency during sleep. LivaNova’s approach utilizes six strategically positioned electrodes on the proximal trunk of the nerve, enabling broader activation of airway muscles and offering enhanced flexibility in therapy titration compared to earlier-generation systems.
A total of 104 participants were enrolled in the trial, which employed a rigorous randomized, no-stimulation-controlled design with a 2:1 allocation ratio. Patients in the treatment arm began receiving therapy at one month (M1), while those in the control arm initiated therapy at month seven (M7). The primary endpoint was assessed at M7 and focused on the proportion of patients achieving at least a 50% reduction in AHI from baseline, along with an absolute AHI below 20 events per hour.
Following this primary endpoint evaluation, all participants entered an open-label extension phase, during which both groups received active therapy through month 13 (M13), corresponding to 12 months of treatment for the initial therapy group.
The results were compelling across multiple dimensions. In terms of objective outcomes, patients receiving pHGNS therapy experienced substantial reductions in AHI. The median AHI in the treatment group decreased from 34.3 events per hour at baseline to 11.6 events per hour at M7. The difference between treatment and control groups at this time point was statistically significant, with a median reduction of −18.9 events per hour. By M13, sustained improvements were observed, with the treatment group maintaining a median AHI of 11.0 events per hour, while the control group—now receiving therapy—achieved a median AHI of 20.9 events per hour.
Similarly, improvements were observed in the oxygen desaturation index (ODI), a key measure of oxygen level fluctuations during sleep. At M7, 69% of patients in the treatment group achieved at least a 25% reduction in ODI, compared to 38% in the control group. Median ODI improved markedly from 35 events per hour at baseline to 13 events per hour in treated patients.
Beyond these physiological measures, the study also demonstrated meaningful enhancements in subjective outcomes, which are critical for assessing real-world therapeutic value. Clinician-rated assessments using the Clinical Global Impression–Improvement (CGI-I) scale showed a response rate of 56% in the treatment group at M7, compared to just 9% in the control group. This response rate further improved to 59% at M13, underscoring the durability of clinical benefits.
Patient-reported outcomes echoed these findings. Scores on the Epworth Sleepiness Scale (ESS), which measures daytime sleepiness, improved significantly in the treatment group, with median scores decreasing from 10.0 to 6.0 at M7—exceeding the threshold for minimal clinically important difference. In contrast, no meaningful change was observed in the control group during this period. By M13, both groups demonstrated improvements following initiation of therapy.
The Functional Outcomes of Sleep Questionnaire (FOSQ), which assesses the impact of sleep disorders on daily activities, also showed notable gains. Patients in the treatment arm improved from a median score of 15.8 at baseline to 17.8 at M7, again meeting clinically meaningful thresholds. By the end of the study, both groups achieved median scores above 18, reflecting substantial improvements in daily functioning and quality of life.
Another important finding was the significant reduction in sleep arousals. Patients in the treatment group experienced a decline in arousal index from approximately 55 events per hour at baseline to 29 events per hour at M13. Notably, respiratory-related arousals were nearly eliminated, although some non-respiratory arousals persisted.
Safety outcomes were equally encouraging. No serious adverse events related to the procedure or device were reported. Most treatment-emergent adverse events were mild to moderate in nature, with the most common being headache, discomfort at the implant site, and transient difficulty swallowing.
Ahmet Tezel emphasized the significance of these findings, describing OSPREY as the most rigorous evaluation of neurostimulation therapy for OSA to date. He noted that LivaNova’s pHGNS technology is uniquely designed to provide more comprehensive control of the airway, enabling treatment of a broader patient population, including those traditionally considered challenging to manage.
Importantly, the study’s inclusion criteria and baseline characteristics closely mirrored those seen in real-world clinical settings. Unlike many prior trials, OSPREY did not exclude patients with complete concentric collapse. Using a predictive algorithm, researchers confirmed that the proportion of patients at risk for CCC in the study was consistent with general OSA populations. Encouragingly, therapeutic responses in this subgroup were comparable to those observed in the overall cohort, highlighting the robustness and generalizability of the treatment effect.
Lucile Blaise highlighted the broader implications of these results, noting that OSA affects up to one billion people globally, yet remains significantly underdiagnosed and undertreated. She underscored the company’s commitment to expanding access to innovative therapies and providing alternatives for patients who cannot tolerate conventional treatments.
From a regulatory standpoint, LivaNova has already achieved a major milestone. The company received premarket approval (PMA) from the U.S. Food and Drug Administration for the aura6000 System, based on the successful achievement of primary safety and efficacy endpoints at six months in the OSPREY trial. This approval positions the company to advance commercialization efforts and further develop its neurostimulation platform.
Looking ahead, LivaNova is actively preparing a next-generation version of its OSA device for submission as a PMA supplement. The updated system is expected to incorporate several advanced features, including compatibility with magnetic resonance imaging (MRI), enhanced remote configuration capabilities, and a long-lasting rechargeable battery with an anticipated lifespan of up to 15 years.
Pending regulatory review and approval, the company anticipates launching its OSA therapy commercially as an independent product offering by 2027. If successful, this could represent a paradigm shift in the management of obstructive sleep apnea, offering patients a durable, effective, and patient-friendly alternative to existing therapies.
In summary, the publication of the OSPREY trial’s full 12-month data marks a pivotal moment in the evolution of neurostimulation therapies for sleep disorders. By demonstrating sustained improvements across objective and subjective measures, along with a strong safety profile, LivaNova’s pHGNS approach has the potential to redefine treatment standards and significantly improve outcomes for patients living with moderate to severe obstructive sleep apnea.
About LivaNova’s OSPREY Study
OSPREY, a prospective, multi-center, randomized, controlled, open-label clinical trial, evaluated the safety and efficacy of the aura6000™ System compared to a no-stimulation control in adult subjects with moderate to severe obstructive sleep apnea (OSA) who failed, do not tolerate, or are ineligible for treatment with standard-of-care therapies, including positive airway pressure (PAP). Data from the OSPREY trial supported U.S. Food and Drug Administration (FDA) approval of the aura6000 System (PMA P250013).
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a vision to change the trajectory of lives for a new day. Through ingenious medical solutions in select neurological and cardiac conditions, LivaNova strives to ignite patient turnarounds. Headquartered in London, with approximately 3,300 employees and a presence in more than 100 countries, LivaNova serves patients, healthcare professionals, and healthcare systems worldwide.
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