Proximal hypoglossal nerve stimulation found effective for obstructive sleep apnea

1. In this randomized controlled trial, proximal hypoglossal nerve stimulation (pHGNS) was effective in improving obstructive sleep apnea (OSA) in adults who had previously not responded to positive airway pressure (PAP) therapy.

2. No serious adverse events were associated with the pHGNS device or implantation, and most treatment-related adverse events were mild or non-serious in severity.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Nasal positive airway pressure (PAP) therapy remains the first-line treatment for obstructive sleep apnea (OSA), though tolerance varies significantly among patients. Hypoglossal nerve stimulation (HGNS) has been approved by the U.S. Food and Drug Administration as an alternative therapy, but its overall efficacy continues to be defined. This study evaluated the safety and effectiveness of percutaneous HGNS (pHGNS) over a 6-month treatment period with 1-year follow-up. Compared with controls, participants receiving pHGNS were more likely to achieve clinically meaningful improvements in apnea-hypopnea index (AHI). They also demonstrated reductions in oxygen desaturation events, improved clinician-rated global improvement, and higher oxygen saturation nadirs. Patient-reported outcomes, including daytime sleepiness and its impact on daily functioning, improved in the treatment group but not in controls. These benefits were largely sustained or further improved at 1-year follow-up, including reductions in sleep arousals. The pHGNS device and implantation procedure were generally well tolerated, with no serious adverse events reported. The majority of treatment-related adverse events were mild in severity, and no clinically meaningful changes were observed in heart rate or blood pressure. Limitations of the study include lack of blinding, a relatively small sample size, and limited follow-up duration, which may affect generalizability. Overall, these findings suggest that pHGNS may be a safe and effective treatment option for patients with OSA who are unable to tolerate or have failed PAP therapy.

Click to read this study in AIM

Relevant Reading: Upper-Airway Stimulation for Obstructive Sleep Apnea

In-Depth [randomized controlled trial]: This randomized controlled trial evaluated the efficacy and safety of percutaneous hypoglossal nerve stimulation (pHGNS) for obstructive sleep apnea (OSA). Adults ≥22 years with BMI ≤35 kg/m² and moderate-to-severe OSA (AHI 15–65 events/h) who were previously unresponsive to PAP therapy were recruited from 23 primary care centers across the United States. Patients were excluded for conditions such as chronic insomnia, moderate-to-severe respiratory disease, and cerebrovascular disease. The primary outcome was the proportion of patients achieving an AHI response at 7 months, defined as ≥50% reduction in AHI from baseline and an AHI <20 events/h. Secondary outcomes included AHI response at 13 months, oxygen desaturation index (ODI), Clinical Global Impression of Improvement (CGI-I), SpO₂ nadir, and patient-reported outcomes (Epworth Sleepiness Scale [ESS] and Functional Outcomes of Sleep Questionnaire [FOSQ]). A total of 104 patients were enrolled (67 pHGNS, 37 control). Mean age was 55.6 years, mean BMI 30.6 kg/m², and baseline AHI 35.7 events/h. All participants underwent successful outpatient implantation without hospitalization. At 7 months, the AHI response rate was 58.2% in the pHGNS group versus 13.5% in controls. The treatment group also showed improvements in ODI, CGI-I, and SpO₂ nadir compared with baseline, along with reductions in AHI and ODI that were not seen in controls. By 13 months, both groups demonstrated improvements in several sleep parameters, though changes were earlier and more pronounced in the treatment group. The arousal index in the treatment group decreased from ~55 per hour at baseline to 29 per hour at 13 months. ESS scores improved at 7 months only in the pHGNS group but improved in both groups by 13 months. FOSQ scores showed a similar pattern. No serious adverse events occurred. Most adverse events were mild, including headache, implant site pain, and dysphagia; 12.5% were related to stimulation and 41.3% to implantation, with ≥75% classified as non-serious. No clinically meaningful changes in heart rate or blood pressure were observed. Overall, pHGNS appears safe and effective for treating OSA in patients unable to tolerate PAP therapy.

Image: PD

©2026 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.