OBJECTIVETo observe and evaluate the clinical efficacy of transcutaneous vagus nerve stimulation (taVNS) at auricular concha for primary insomnia (PI) and affective disorder.

METHODSA total of 35 patients who met the diagnosis standard of PI in(5th edition) were included. The self-developed auricular vagus nerve stimulator (TENS-200A) was applied at auricular concha, 30 min per treatment, twice a day, 5 days a week for consecutive 4 weeks. The follow-up visit was conducted at the end of 6th week. The Pittsburg sleep quality index scale (PSQI), 17-items Hamilton depression scale (17HAMD) and Hamilton anxiety scale (HAMA) were applied for evaluation. The PSQI, HAMA and 17HAMD were observed before and after treatment; the safety was also observed.

RESULTSCompared before treatment, the PSQI was significantly decreased to (13.20±3.61) at the end of 2nd week (<0.05); compared before treatment, the 17HAMD and HAMA were significantly decreased at the end of 4th week and 6th week (all<0.05). No adverse reaction was observed.

CONCLUSIONSThe taVNS could not only relieve PI symptoms, but also improve the depressive and anxiety symptoms, in addition, it may have positive long-term efficacy and safety.