Obstructive sleep apnoea (OSA) is a sleep-related breathing disorder due to upper airway collapse. Current standard therapy is CPAP therapy, but its effectiveness is limited due to poor compliance. An alternative therapeutic approach is the electrical stimulation of the hypoglossal nerve (HGNS), using an implant to promote airway opening.

For this second update on the assessment of the efficacy and safety of HGNS, an update search was conducted and an EUnetHTA report from 2020 was used as a basis. The update search provided one comparative parallel-arm study for the evaluation of efficacy and one sham-controlled crossover RCT as well as two observational studies for the evaluation of safety. Compared to no therapy, improvements in efficacy endpoints were observed with HGNS after one year. Several serious adverse events were recorded in the observational studies, most of which were due to serious adverse device-related events.

The available evidence does not allow valid conclusions to be drawn about the efficacy of HGNS compared to no therapy and whether HGNS is safe in the target population.