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
Chronic tinnitus
The TinnSpire stimulation sessions have five elements. Firstly, participants will be asked to rate their tinnitus loudness on a VAS at the start of the session. Physiological data will then be collected using a medical grade ‘Nexus 10’ device, with finger photoplethysmography (PPG) and an abdominal respiration sensor. Five minutes and 15 seconds of data will be recorded. Transcutaneous vagus nerve stimulation The taVNS electrodes will be placed on the cymba concha of both ears using conductive gel, with headphones placed over the top. The taVNS parameter settings are consistent with the majority of other taVNS tinnitus studies, with a frequency of 25 Hz and a pulse width of 200 μs. Stimulation will be delivered using a commercially available TENS device, EM-6300A TENS/EMS (Med-Fit UK Ltd), CE 2460. To set the taVNS amplitude, a standard Parametric Estimation by Sequential Testing (PEST) method will be used to determine the individual’s perceptual threshold, defined as the minimum current required to elicit a perceived sensation. Broadband shaped-noise sound therapy Auditory stimulation will be presented to each participant during the approximately 30 minute TinnSpire stimulation sessions. The stimuli will consist of a broadband signal of approximately 200 Hz to 8 kHz, with frequency-specific level adjustments matched to the participant’s hearing threshold levels (HTL). Participants will be asked to select from different sound types, ranging from static unmodulated sounds such as white noise to natural modulated sounds such as ocean sounds, to avoid undesirable sound quality. Stimuli will be delivered using supra-aural headphones. The sound level will be adjusted by the participant to an audible and comfortable level. Slow diaphragmatic resonant breathing Once the taVNS amplitude and audio volume have been established, participants will be asked to sit still and breathe at six breaths per minute while watching a visual respiration pacer on a laptop. Particip
1. Chronic subjective tinnitus (defined as tinnitus duration 6 months or more) 2. English speaking 3. Male and Female 4. ≥ 18 years 5. > 17 Tinnitus Functional Index Score
1. Active care in audiology for tinnitus 2. Objective tinnitus 3. Acute tinnitus 4. Pulsatile tinnitus 5. Conductive hearing loss 6. Active middle ear pathology (defined by audiological assessment) 7. Severe-to-profound sensori-neural hearing loss (defined by audiological assessment) 8. Ménière’s disease 9. Skin lesions or piercing or extensive tattooing of the concha or skin disease: infection or eczema of the ears 10. Active implant, e.g. ICD, pacemaker, neurostimulator, cochlear implant, and VP shunt 11. Ongoing vagal nerve stimulation or s.p. vagotomy 12. Progressive neurological disease (e.g. Parkinson’s, epilepsy, multiple sclerosis) 13. Relevant cardiac disease, e.g. bradycardic arrhythmia, insufficiency, and s.p. infarction 14. Severe psychiatric disease (e.g. schizophrenia) 15. Pregnant 16. Breathing-related difficulties (e.g. COPD, emphysema, or asthma) 17. Raynaud's disease 18. Beta blockers 19. Involvement in any clinical study within the last 28 days