Journal of Clinical Trials

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 7868 792050


Transcutaneous Vagus Nerve Stimulation for the Treatment of Insomnia Disorder: A Study Protocol for a Double Blinded Randomized Clinical Trial

Li Shao-Yuan, Jiao Yue, Rong Pei-Jing, Li Su-Xia, Yu Yu-Tian, Lu Lin and Tang Xiang-Dong

Background: Insomnia disorder (ID) is a prevalent and costly health condition. Pharmacological treatment, one of the most common treatments provided by primary caregivers, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. Cognitive Behavioral Therapy for Insomnia is recommended. Effectiveness, however, is still limited. Another opportunity for optimization of treatment is based on the idea that the people suffering from insomnia most is seen as an organic unity, with acupuncture, a typical traditional Chinese medicine, can provide expected treatment responses. This double-blind controlled randomized multicenter clinical trial aims to examine whether noninvasive transcutaneous vagus nerve stimulation (taVNS) is a safe and tolerable alternative treatment option for insomnia disorder.

Design: A random sample of seventy - four participants with insomnia disorder will receive transcutaneous vagus nerve simulation (taVNS) or transcutaneous non-vagus nerve simulation (tnVNS) for 4 weeks and for 2 weeks follow-up afterwards. The primary outcomes are PSG parameter, Pittsburgh Sleep Quality Index (PSQI) score, and the concentration of melatonin in plasma. The secondary outcomes are Epworth, Flinders, Hamilton Depression Rating Scale (HDRS; 17 items), Hamilton Anxiety Scale (HAMA;14 items), the MOS item short from health survey (SF-36), Heart Rate Viability (HRV) and functional magnetic resonance imaging (fMRI). PSQI, Epworth and Flinders are to be assessed at baseline and on the 7th, 14th, 21th, and 28th day of treatment and the 14th day of follow-up afterwards. PSG, melatonin, HRV and fMRI are to be detected measured at baseline and on the 28th day of treatment. 17 HDRS, 14HAMA and SF-36 are to be assessed at baseline and on the 28th day of treatment and the 14th day of follow-up afterwards.

Discussion: This study evaluates the effects of taVNS on insomnia disorder and on the quality of life of patients.