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Contact Information:

Alan Sanderson
a.sanderson@bsms.ac.uk


Alan Sanderson
a.sanderson@bsms.ac.uk


Study Location:

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Be Part of Research - Trial Details - TinnSpire:Personalised vagus nerve & sound stimulation for tinnitus_v6

TinnSpire:Personalised vagus nerve & sound stimulation for tinnitus_v6

Recruiting

Open to: Female / Male

Age: 18 Years - N/A

Medical Conditions

Other disorders of ear


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 isÍľ could the combination of taVNS, BSN Sound Therapy and resonant breathing, be a practical intervention that could reduce tinnitus symptoms and stress.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Jul 2024 01 Nov 2024

Interventional

Interventional type: Complex Intervention;Rehabilitation;



You can take part if:



You may not be able to take part if:


● Tinnitus Functional Index < 90 points ● Objective tinnitus ● Acute tinnitus ● Pulsatile Tinnitus ● Conductive Hearing loss ● Active middle ear pathology ● Significant sensori-neural Hearing loss ● > mild hearing loss (target group is normal to mild hearing levels) ● Retrocochlear lesions such as auditory neuropathy and acoustic neuroma ● Traumatic hearing loss ● Ménière’s disease ● Skin lesions or piercing or extensive tattooing of the concha or Skin disease: infection or eczema of the ears ● Active implant, e.g. ICD, pacemaker, neurostimulator, cochlear implant, and VP shunt ● Ongoing vagal nerve stimulation or s.p. vagotomy ● Progressive neurological disease (e.g., Parkinson’s, epilepsy, multiple sclerosis) ● Relevant cardiac disease, e.g., bradycardic arrhythmia, insufficiency, & s.p. infarction ● Severe psychiatric disease (e.g., schizophrenia) ● Pregnant ● Breathing-related difficulties (e.g., COPD, Emphysema, or asthma), ● Raynaud's disease ● Beta blockers


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Sussex County Hospital
    Eastern Road
    Brighton
    BN2 5BE

Alan Sanderson
a.sanderson@bsms.ac.uk


Alan Sanderson
a.sanderson@bsms.ac.uk



The study is sponsored by University of Sussex and funded by NIHR Central Commissioning Facility (CCF) .




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for Trial ID: CPMS 61735

Last updated 06 February 2025

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