TinnSpire:Personalised vagus nerve & sound stimulation for tinnitus_v6

• Research type

  Research Study

• Full title

  TinnSpire: Open-label, Single Arm, non-randomised, Feasibility study of Bimodal Transcutaneous auricular vagus nerve stimulation & Broadband Shaped-Noise Sound Therapy with Slow Resonant Breathing for the treatment of tinnitus.

• IRAS ID

  336506

• Contact name

  Alan Sanderson

• Contact email

  a.sanderson@bsms.ac.uk

• Sponsor organisation

  University of Sussex

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  Tinnitus is the perception of sound in the absence of an external sound source and has a prevalence of between 10 and 30% with 2% being severely affected. It is believed that most subtypes of tinnitus result from a maladaptive neuroplasticity of the auditory cortex, triggered by hearing loss and exacerbated by stress.
  The current psychological interventions focus on helping sufferers come to terms with the annoyance and stress of the tinnitus. Sound therapy aims to promote habituation to tinnitus by presenting one of many types of modulated noise. Neither intervention is universally effective and there are no effective medications. The use of hearing aids can be helpful for individuals with hearing loss.
  In the last few years a number of studies have shown some benefit of transcutaneous auricular vagus nerve stimulation (taVNS) in the reduction of tinnitus symptoms. This involves the placement of electrodes on the ear and the appliance of very small electrical pulses that are designed to activate the vagus nerve and help induce the “rest and digest” response of the parasympathetic system. It is also believed that taVNS can help induce neuroplasticity.
  Slow diaphragmatic resonant breathing at 6 breaths per minute. This resonant breathing has been used effectively to help with many stress related conditions such as pain, irritable bowel syndrome and anxiety.
  There are a number of studies looking at Broadband Shaped-Noise (BSN) Sound Therapy, which uses sounds that are adjusted to match the participants' hearing threshold levels (HTL), in order to retrain the auditory system to compensate for the part of the spectrum that is not being heard anymore. This may be facilitated by the relaxing effect of resonant breathing and taVNS.
  Thus the research question is; could the combination of taVNS, BSN Sound Therapy and resonant breathing, be a practical intervention that could reduce tinnitus symptoms and stress.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  24/EE/0069

• Date of REC Opinion

  7 May 2024

• REC opinion

  Further Information Favourable Opinion