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. 2022 Sep 26;12(10):1296.
doi: 10.3390/brainsci12101296.

Transcutaneous Vagus Nerve Stimulation Could Improve the Effective Rate on the Quality of Sleep in the Treatment of Primary Insomnia: A Randomized Control Trial

Yating Wu  1   2 , Lu Song  3 , Xian Wang  1 , Ning Li  1 , Shuqin Zhan  1 , Peijing Rong  4 , Yuping Wang  1 , Aihua Liu  1
Affiliations

Transcutaneous Vagus Nerve Stimulation Could Improve the Effective Rate on the Quality of Sleep in the Treatment of Primary Insomnia: A Randomized Control Trial

Yating Wu et al. Brain Sci. .

Abstract

(1) Background: The purpose of this study was to investigate the efficacy and safety of transcutaneous vagus nerve stimulation (t-VNS) in the treatment of primary insomnia. (2) Methods: This is a single center, randomized, double-blind study. A total of 30 patients diagnosed with primary insomnia were randomly divided into two groups to receive 20 Hz t-VNS in either the auricular concha area (treatment group) or periauricular area (control group), twice a day for 20 min during a one-month study period. The effective rate of treatment, defined as a ≥50% reduction of the Pittsburgh Sleep Index Scale (PSQI) after treatment, was compared between the two groups as the primary outcome. Response rate (defined as ≥10% change in the PSQI score), and changes in the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) scores were also assessed. (3) Results: After one month of treatment, the PSQI score of the treatment group decreased significantly (p = 0.001). The effective rate of the treatment group (73% vs. 27%, p = 0.027) was significantly higher than that of the control group. No statistical differences in changes of HAMA and HAMD scores were detected between the two groups. There were no complications in all patients. (4) Conclusion: T-VNS appeared to be a safe and effective treatment for primary insomnia.

Keywords: Pittsburgh Sleep Index; anxiety; depression; primary insomnia; transcutaneous vagus nerve stimulation.

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Conflict of interest statement

The authors declare no conflict of interests.

Figures

Figure 1
Figure 1
The timeline diagram of the study process, which demonstrates the whole process of study including the follow-up.
Figure 2
Figure 2
Positioning of the electrode of the t-VNS device for stimulation in the treatment and control groups.
Figure 3
Figure 3
A flowchart of the study. The number of enrolled patients was 32 in total, and equal numbers of patients were randomly grouped into treatment and control groups. One patient in the treatment group discontinued the study due to unsatisfactory effects associated with the therapy, and another patient dropped out from our study because of adding sleeping medicine.
See this image and copyright information in PMC

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