OBJECTIVES: Conducting a systematic literature review to investigate the efficacy and safety of hypoglossal nerve stimulation (HGNS) in treating obstructive sleep apnea (OSA). Evaluation based on defined patient-reported outcomes and other parameters, considering different stimulation technologies.

METHODS: Systematic literature search using the PICOS scheme in the databases Medline (PubMed) and Cochrane Library, and systematic literature evaluation for the parameters daytime sleepiness, quality of life, adherence, apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and safety.

RESULTS: 33 publications were included and evaluated: 2 randomized controlled trials (RCTs, Level Ib), 1 study Level IIb (n = 1), and 30 Level IV studies. Some publications describe the same study population over time. The maximum observation period is 60 months. The patient-relevant endpoints daytime sleepiness and quality of life showed better values in the RCTs under HGNS treatment than the control group. Under placebo stimulation or therapy withdrawal, AHI and ODI worsened in the RCTs. In the other studies, similar results were found for all parameters examined. The adherence results remained at a consistently high level over the long term. The adverse events under HGNS were mostly temporary or could be resolved by non-invasive measures, serious adverse events were rare and could mostly be resolved by repositioning of electrodes or the replacement of device parts.

CONCLUSIONS: The evaluation of the 33 publications confirms hypoglossal nerve stimulation, as shown by consistent results in different studies, as an effective and safe treatment alternative for patients with OSA after unsuccessful CPAP therapy. Using real-world data, the application of HGNS should be systematically evaluated to gain more insights into the relevance of the method in clinical routine.