Three-year outcomes of proximal hypoglossal nerve ytimulation in OSA
Background - Targeted proximal hypoglossal nerve stimulation was shown to improve sleep-disordered breathing, sleep architecture, and quality of life (QOL) with a favorable safety profile over 1 year in the Targeted Hypoglossal Stimulation 3 (THN3) randomized controlled trial. Herein, THN3 proximal...
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| Autori principali: | , , , , , , , , , , , , , , , , , |
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| Natura: | Article (Journal) |
| Lingua: | inglese |
| Pubblicazione: |
May 2026
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| In: |
Chest
Year: 2026, Volume: 169, Fascicolo: 5, Pages: 1357-1370 |
| ISSN: | 1931-3543 |
| DOI: | 10.1016/j.chest.2025.11.057 |
| Accesso online: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.chest.2025.11.057 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0012369226001480 
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| Note sull'autore: | Alan R. Schwartz, MD, Ofer Jacobowitz, MD, PhD, Samuel A. Mickelson, MD, Mitchell B. Miller, MD, Arie Oliven, MD, Victor Certal, MD, PhD, Martin L. Hopp, MD, PhD, David H. Winslow, MD, Tod C. Huntley, MD, Nathan E. Nachlas, MD, Luu V. Pham, MD, David W. Eisele, MD, M. Boyd Gillespie, MD, Brian H. Weeks, MD, Eric G. Lovett, PhD, John Shen, MS, Atul Malhotra, MD, and Joachim T. Maurer, MD |
| Riassunto: | Background - Targeted proximal hypoglossal nerve stimulation was shown to improve sleep-disordered breathing, sleep architecture, and quality of life (QOL) with a favorable safety profile over 1 year in the Targeted Hypoglossal Stimulation 3 (THN3) randomized controlled trial. Herein, THN3 proximal hypoglossal nerve stimulation (pHGNS) 3-year safety and efficacy are profiled with reference to distal hypoglossal nerve stimulation (dHGNS) from the Stimulation Therapy for Apnea Reduction (STAR) trial. - Research Question - What are the long-term safety and efficacy of pHGNS, and how do they compare with dHGNS? - Study Design and Methods - THN3 (NCT02263859) enrollees had an apnea-hypopnea index (AHI) 20-65/hr and BMI ≤ 35 kg/m2. Participants completing the prespecified 3-year visit were analyzed. Outcomes included adverse events, AHI, Oxygen Desaturation Index, percentage of sleep time with oxygen saturation <90%, and QOL. pHGNS responses at 24 and 36 months were compared with baseline and 11 months of therapy (months 12/15). pHGNS and dHGNS results were compared through 36 months. - Results - One hundred four of 138 (75%) THN3 participants completed 3-year follow-up. pHGNS delivered sustained improvements in sleep-disordered breathing, oxygenation, and QOL at months 24 and 36 vs baseline. Long-term outcomes were comparable to those at 11 months of treatment: median AHI reductions were -15.1/h (95% CI, -18.6, -12.6) and -17.7/h (-21.9, -15.3) with large effect sizes; probabilities of superiority vs baseline were 0.79 (0.72-.87) and 0.79 (0.70-.87), respectively. Benefits in sleep-disordered breathing and QOL were sustained at 36 months and appeared to be comparable to those reported for dHGNS at 3 years. - Interpretation - Therapeutic responses to pHGNS at 1 year were maintained through 3 years with relatively few adverse events. Similarities in responses to dHGNS suggest that pHGNS provides safe and efficacious long-term OSA treatment. - Clinical Trial Registration - ClinicalTrials.gov; No.: NCT02263859; URL: www.clinicaltrials.gov |
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| Descrizione del documento: | Online verfügbar: 12. Februar 2026, Artikelversion: 8. Mai 2026 Gesehen am 09.07.2026 |
| Descrizione fisica: | Online Resource |
| ISSN: | 1931-3543 |
| DOI: | 10.1016/j.chest.2025.11.057 |