[Ten years of hypoglossal nerve stimulation in obstructive sleep apnea: a systematic literature review]. / Zehn Jahre Hypoglossusnerv-Stimulation bei obstruktiver Schlafapnoe ­ ein systematischer Literaturreview.

ABSTRACT

OBJECTIVE: To show the importance of hypoglossal nerve stimulation (HGNS) as a treatment method for obstructive sleep apnea (OSA) in the German healthcare context and to better assess the way patients who do not receive adequate care could benefit from HGNS. METHODS: A systematic literature review in the Medline and Cochrane Library literature database was conducted, including publications using different stimulation technologies for HGNS. The efficacy of HGNS was assessed based on patient-relevant outcomes (daytime sleepiness, quality of life), treatment adherence and the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI). The safety of the treatment method was assessed based on adverse events (AEs). RESULTS: Inclusion and analysis of 33 publications 2 randomized controlled trials (RCTs, level Ib), 1 level IIb trial (n = 1) and 30 level IV trials with a study duration of up to 60 months. The RCTs showed better values for daytime sleepiness and quality of life when using HGNS than in the control group. AHI and ODI showed a deterioration under placebo stimulation or therapy withdrawal in the RCTs. Consistently high adherence was also reported in the long-term course. Severe AEs under HGNS were rare and could usually be resolved by repositioning electrodes or replacing device components. Other AEs were mostly transient or could be resolved by non-invasive measures. All investigated parameters showed similar results in the evaluated studies. The results of different stimulation systems are comparable in type and extent. CONCLUSION: The comprehensive review of the literature shows consistent data that highlight the importance of HGNS as an effective and safe treatment for OSA after unsuccessful CPAP treatment. The evaluation also shows that the different stimulation systems make it possible to better tailor the therapy to the patient's individual requirements. A future systematic evaluation of real-world data on the use of HGNS would help gain additional insights into the relevance of the method in routine clinical practice.