Effect and neurophysiological mechanisms of transcutaneous auricular vagus nerve stimulation (taVNS) for misophonia (taVNS-MISO): a study protocol for a single-centre double-blind randomised sham-controlled trial
Abstract
Introduction: Misophonia is a newly recognised sound sensitivity disorder with clinically significant symptoms affecting up to 18% of the population. It is characterised by extreme negative reactions to specific sounds which are often repetitive and generated by the human oral-nasal tract (eg, sniffing and eating sounds). Although misophonia currently has no standard treatment, research suggests that transcutaneous auricular vagus nerve stimulation (taVNS) holds promise therapeutically. This study aims to investigate both the effects of 4 weeks taVNS (compared with sham) on misophonia and related symptoms as well as its underlying neurophysiological mechanisms. To our knowledge, this is the first trial on taVNS in misophonia.
Methods and analysis: This is a single-centre double-blind sham-controlled trial in which 60 participants with clinically significant misophonia are randomly allocated in a 1:1 ratio to receive taVNS or sham stimulation. The intervention will be self-administered over 4 weeks (two times per day for 30 mins each). The primary efficacy outcome is self-reported misophonia severity with secondary outcomes, including mental health and audiological symptoms. In addition, all participants will undergo preintervention and postintervention testing, including MRI and physiology to investigate neurophysiological mechanisms underlying taVNS effects.
Ethics and dissemination: The study has been approved by the Brighton and Sussex Medical School ethics board…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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