Abstract
Hypoglossal nerve stimulation (HGNS) has emerged as a widespread and innovative treatment option for selected moderate-to-severe obstructive sleep apnea (OSA) patients who cannot be treated effectively with traditional treatment modalities. In this observational cohort study, the objective and subjective outcomes of Belgian OSA patients treated with HGNS therapy were analyzed at 6 and 12 months post-implantation. Thirty-nine patients implanted with a respiration-synchronized HGNS device at the Antwerp University Hospital w ere included in this study. Patients underwent baseline in-laboratory polysomnography and a follow-up sleep study 6 and 12 months post-implantation. Questionnaires on patient experience and daytime sleepiness were filled out and data on objective therapy usage were collected. All 39 patients completed the 6-month follow-up and 21 patients (54%) completed the 12-month follow-up. Median AHI decreased from 33.8 [26.1;45.0] to 10.2 [4.8;16.4] at the 6-month follow-up, and to 9.6 [4.1;16.4] at the 12-month follow-up (p < 0.001). The surgical success rate, according to the Sher20 criteria, was 80% and 76% at the 6- and 12-month follow-ups, respectively. Median ESS improved from 12.0 [7.0;18.0] at baseline to 6.0 [2.5;11.0] at 6 months (p < 0.001) and to 6.5 [2.8;11.5] at 12 months (p = 0.012). Objective therapy usage was 7.4 [6.6;8.0] and 7.0 [5.9:8.2] h/night at the 6- and 12-month follow-ups, respectively. A high overall clinical effectiveness of HGNS therapy, as shown by a mean disease alleviation of 58%, was demonstrated at 12 months post-implantation. Overall, HGNS therapy using respiration-synchronized neurostimulation of the XII cranial nerve resulted in a significant improvement in both objective and subjective OSA outcomes, with a high level of patient satisfaction and high treatment adherence.
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