OSPREY Obstructive Sleep Apnea Trial Achieves Positive Predictive Outcome

Enrollment for the Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation (OSPREY) clinical study is expected to conclude earlier than anticipated due to an achieved positive predictive outcome for patients with obstructive sleep apnea (OSA) undergoing targeted hypoglossal neurostimulation therapy.¹

OSA is a debilitating sleep disorder characterized by recurrent periods of upper airway obstruction during sleep, which is attributable to the loss of pharyngeal neuromuscular activity. The genioglossus, a dilator muscle, maintains pharyngeal patency by preventing the tongue from prolapsing into the pharynx.² Targeted Hypoglossal Nerve Stimulation Sleep Therapy involves a fully implantable device called the aura6000^TM by medical technology company, LivaNova, which stimulates the tongue during sleep by sending mild pulses to the hypoglossal nerve in the neck.³ Electrical stimulation of the hypoglossal nerve leads to decreased pharyngeal collapsibility and relief of airflow in patients with OSA.²

Researchers are conducting OSPREY (ClinicalTrials.gov Identifier: NCT04950894), a prospective, multicenter, open-label, randomized clinical trial, to evaluate the safety and effectiveness of the aura6000^TM Hypoglossal Nerve Stimulator System in patients with moderate to severe OSA who are unable or unwilling to use positive airway pressure treatment.

The primary outcomes of interest are the rate of response to therapy compared with no therapy for 6 months, as well as the rate of all serious adverse device/procedure-related events from time of implant through month 7.

Patients were eligible for inclusion if they were aged 22 and older, had a diagnosis of moderate to severe OSA, and declined to use or cannot tolerate positive airway pressure. Patients were excluded if they had a body mass index (BMI) greater than 35 or a comorbid condition, including respiratory, cardiac, or renal disease. Enrollment was open in multiple states across the United States including Alabama, Arizona, California, Florida, Georgia, Kentucky, Nebraska, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Texas, and Utah.⁴

With the start of study, all patients will be implanted and randomly assigned 2:1 to either the active group, beginning targeted hypoglossal neurostimulation therapy at month 1, or the control group, beginning the same therapy at month 7, respectively.⁴ Response, as defined by OSPREY, is at least 50% improvement from baseline the baseline apnea-hypopnea index, leading to an apnea-hypopnea index (AHI) value less than 20.¹ 

A total of 90 patients were included in the planned interim analysis that enabled researchers to estimate a high chance of success for achieving the positive predictive outcome. This achievement indicates a greater than 97.5% probability that the trial will successfully meet its primary endpoint, prompting the conclusion of enrollment earlier than anticipated.¹

“We are now able to estimate a high chance of success for achieving the primary endpoint in this unique randomized controlled trial without further patient enrollment,” said Atul Malhotra, MD, professor of medicine at University of California, San Diego and principal investigator for OSPREY, in a news release.¹ Dr Malhotra added, “While this milestone shows we are on a positive trajectory, long-term follow-up visits will continue for each patient through the primary endpoint and beyond.”

OSPREY’s final clinical module will be submitted to the US Food and Drug Administration (FDA) by LivaNova after the entire cohort has completed the final follow-up visit and final analysis has been conducted.