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Implanted nerve stimulation for obstructive sleep apnea found to be safe and effective in new trial
A randomized controlled trial evaluating the safety and efficacy of proximal hypoglossal nerve stimulation, or pHGNS, (an implanted stimulation therapy targeting specific sectors of nerves in the tongue) for obstructive sleep apnea (OSA) found that pHGNS significantly reduced beathing interruptions during sleep and improved patient-reported daytime sleepiness without any significant adverse events. The study is published in Annals of Internal Medicine.
Hypoglossal nerve stimulation (HGNS) is an FDA-approved alternative therapy for OSA in patients who cannot tolerate nasal positive airway pressure. pHGNS has emerged as a possible treatment option for OSA that offers more stimulation of the tongue and airway muscles and easier implantation without the need for drug-induced sleep endoscopy compared to HGNS. Researchers conducted the OSPREY (treating Obstructive Sleep aPnea using taRgEted hYpoglossal nerve stimulation) trial to better understand the safety and efficacy of pHGNS. The researchers randomly assigned 104 adults aged 22 and older with moderate-to-severe OSA at 23 U.S. health centers to receive pHGNS therapy immediately (treatment) or at month 7 (control). The primary endpoint was apnea–hypopnea index (AHI) below 20 events/h at month 7, and other outcomes measured included oxygen desaturation index (ODI), patient-reported outcomes, and safety.
After seven months, 58.2% of patients in the treatment group achieved the primary endpoint and patients reported feeling less sleepy during the day. In contrast, clinically meaningful improvements were not observed in the control group through month 7. Continued improvements were seen in the treatment group following a 6-month open-label extension of the trial. No serious complications related to the procedure were reported, suggesting pHGNS may be a reasonable option for patients who cannot tolerate traditional sleep apnea treatments, though longer and larger studies are still needed, according to the authors.
