{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T18:54:48Z","timestamp":1793732088319,"version":"4.6.1"},"reference-count":42,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"IMPORTANCE<\/jats:title>Evidence from randomized clinical trials of transcutaneous auricular vagus nerve stimulation (taVNS) for chronic insomnia disorder is lacking.<\/jats:p><\/jats:sec>OBJECTIVE<\/jats:title>To evaluate the efficacy and safety of taVNS for chronic insomnia compared with the sham taVNS.<\/jats:p><\/jats:sec>DESIGN, SETTING, and PARTICIPANTS<\/jats:title>This randomized clinical trial was conducted from October 2021 to December 2022 at a single center in Beijing, China. Patients with chronic insomnia disorder with a Pittsburgh Sleep Quality Index (PSQI) of at least 8 were enrolled. Statistical analysis was performed from June to September 2023.<\/jats:p><\/jats:sec>INTERVENTIONS<\/jats:title>Patients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 30 minutes each time, twice a day, 5 consecutive days a week, with an 8-week treatment and a 12-week follow-up.<\/jats:p><\/jats:sec>MAIN OUTCOMES AND MEASURES<\/jats:title>The primary end point was the mean change from baseline through week 8 in PSQI scores. Minimal clinically important difference was 2.5 points. Secondary outcomes included mental health, sleepiness, and fatigue. Safety was also evaluated.<\/jats:p><\/jats:sec>RESULTS<\/jats:title>A total of 72 participants were randomized to either active taVNS group (36 participants; mean [SD] age, 45.2 [14.5] years; 27 [75.0%] female) or the sham taVNS group (36 participants; mean [SD] age, 44.6 [13.9] years; 31 [86.1%] female); 68 participants completed the 8-week intervention. The least-square mean changes from baseline to week 8 in PSQI were \u22128.2 (95% CI, \u22129.3 to \u22127.0) points in the taVNS group and \u22123.9 (95% CI, \u22125.1 to \u22122.7) points in the sham group. Both groups experienced statistically significant improvements from before to after the intervention. However, active taVNS showed a clinically meaningful 4.2-point greater reduction (95% CI, \u22125.9 to \u22122.6 points; P<\/jats:italic>\u2009&amp;lt;\u2009.001; Cohen d<\/jats:italic> effect size, 1.2) in PSQI compared with the sham group (minimal clinically important difference\u2009=\u20092.5 points). Secondary outcomes, including mental health and fatigue, showed similar favorable results. The efficacy of taVNS was sustained throughout the 20-week study period.<\/jats:p><\/jats:sec>CONCLUSIONS AND RELEVANCE<\/jats:title>In this randomized clinical trial, taVNS significantly reduced insomnia severity. Clinically meaningful enhancements in PSQI scores were observed compared with sham stimulation, with the benefits of taVNS sustained over a 20-week period. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness across diverse populations.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>Chinese Clinical Trial Registry: ChiCTR2100051319<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2024.51217","type":"journal-article","created":{"date-parts":[[2024,12,16]],"date-time":"2024-12-16T16:32:15Z","timestamp":1734366735000},"page":"e2451217","source":"Crossref","is-referenced-by-count":96,"title":["Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Insomnia Disorder"],"prefix":"10.1001","volume":"7","author":[{"given":"Shuai","family":"Zhang","sequence":"first","affiliation":[{"name":"Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China"},{"name":"Department of Geriatrics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 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