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TinnSpire: Personalised vagus nerve & sound stimulation for the treatment of tinnitus

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22165252
Enrollment
20
Registered
2026-04-15
Start date
2024-08-14
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic tinnitus Ear, Nose and Throat

Interventions

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 collect

Sponsors

University of Sussex
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Countries

England, United Kingdom

Contacts

Public ContactTony Steffert
tony.steffert@sona.help-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026