The SANSA test can now differentiate central from obstructive sleep apnea.

Key takeaways:

• Huxley Medical received FDA 510(k) clearance and announced the commercial launch of central sleep apnea detection for its SANSA home sleep apnea test.
• A clinical study of 325 patients showed the test’s algorithm had 100% sensitivity and 99% specificity for detecting CSA compared to polysomnography.
• The ability to differentiate CSA is particularly relevant for patients with cardiovascular comorbidities like heart failure and atrial fibrillation.
• Nancy A Collop, MD, former director of the Emory Sleep Center and past president of the AASM, has joined Huxley Medical as Medical Director of Sleep Medicine.

Huxley Medical Inc has received US Food and Drug Administration (FDA) 510(k) clearance for its SANSA home sleep apnea test to detect central sleep apnea (CSA) and has begun its commercial release. The company also announced the appointment of Nancy Collop, MD, a past president of the American Academy of Sleep Medicine (AASM), as its new medical director of sleep medicine.

The FDA clearance was supported by clinical performance data presented at the SLEEP meeting earlier this year. The study, which included 325 patients across seven clinical sites, compared the SANSA scoring algorithm to polysomnography. Results demonstrated 100% sensitivity and 99% specificity for the detection of CSA, which was defined as a central apnea index of 10 or greater.

“While less common than obstructive sleep apnea, central sleep apnea is more prevalent in patients with cardiovascular disease such as heart failure and atrial fibrillation,” says Rami Khayat, MD, director of sleep services at Penn State, who presented the validation study results, in a release. “Accurately distinguishing between these conditions is critical, as it can significantly alter treatment decisions. This is an exciting step that will help clinicians stratify and manage patients more efficiently.”

According to Huxley Medical, the test uses artificial intelligence to analyze physiological signals associated with CSA.

“Few home sleep apnea tests are FDA cleared to differentiate central from obstructive sleep apnea,” says Brennan Torstrick, PhD, chief scientific officer at Huxley, in a release. “Our extensive validation across multiple clinical sites and a diverse patient population further expands SANSA’s multi-diagnostic capabilities and gives physicians even more confidence to choose SANSA for determining the most appropriate path to treatment.”

In her new role as medical director of sleep medicine, Collop will help guide Huxley’s clinical and technology development strategy. Collop has previously chaired multiple AASM task forces on home sleep testing, including those that developed clinical guidelines and technology evaluations.

“I am pleased to join Huxley Medical and support its mission to deliver more actionable and accessible diagnostic tools,” says Collop, in a release. “My career has focused on advancing innovation in patient care, and I believe SANSA has significant potential to further evolve the field of sleep medicine.”

Chris Lee, PhD, chair and CEO of Huxley, noted Collop’s long-standing influence in the field. She “has been a champion for patient-first innovation for decades and has fundamentally shaped the field of sleep medicine,” says Lee, in a release. “Her contributions to SANSA’s development have been instrumental. We are honored that she will take on an expanded role.”

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