In This Study, we Are Testing Whether Combining Two Interventions, in the Early Stages of Tinnitus, is More Effective in Quieting Tinnitus Than Using One Treatment Alone in the Later Stages of Tinnitus

NCT07128004 | Not Yet Recruiting

• 2 other identifiers: NU-019970American Tinnitus Association
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Tinnitus affects one in seven adults long-term
• Once present persistently for 4 weeks, tinnitus does not usually disappear
• People generally become less aware of, and less affected by, their tinnitus over time
• Only one in six people with tinnitus suffers a long-term negative impact on their life
• Current treatments can help to reduce the impact of tinnitus, but not silence the sound
• Treatments have only so far been tested once tinnitus has been present longer than 6 months
• In this study, the researchers are testing whether combining two interventions, in the early stages of tinnitus, is more effective in quieting tinnitus than using one treatment alone in the later stages of tinnitus
• One intervention (acoustic ripples) involves playing sounds through headphones for up to 60 minutes per day, and is mostly done in your own time
• The other intervention (transcranial direct current stimulation: tDCS) involves applying a weak electrical current to the volunteer's scalp using sponges soaked in salt water. This is performed in Newcastle University Medical School for a total of 8 sessions of 40 minutes each, spread over 4 weeks
• Half the volunteers will receive the 'real' intervention, and half a 'sham' or 'placebo' version. This will be randomly determined, and the volunteers or the research team will not known which you are receiving until the end of the study
• When the study ends, all volunteers will be able to use the 'real' intervention sounds in their own time, for as long as they wish, if they want to do so. No volunteers will be able to receive tDCS after the end of the study.
• All volunteers also complete questionnaires about their tinnitus, related symptoms and general health, and have hearing tests plus EEG (electrical brainwave) recordings
• The study is very low-risk, but does involve a total of 10 visits of around an hour each to Newcastle University Medical School over around a month. These can be arranged flexibly, including daytimes, evenings and weekends
• The researchers will pay all reasonable travel expenses, and £10 per hour for the volunteer's time in participating
• The study only completely ends 6 months after the date the tinnitus first started. At this point, the researchers will send some questionnaires to complete only. There is nothing to do for the study in between the tenth visit and this six-month questionnaire.

Conditions

Tinnitus; Acute

Keywords

Acute Tinnitus; Treatment; Sound therapy; tDCS

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale

  Primary outcome will be perceived tinnitus loudness assessed using a self-reported Numerical Rating Scale (NRS), where participants rate the loudness of their tinnitus on a scale from 0 to 10. Higher scores indicate greater perceived loudness. The NRS will be administered at baseline and post-intervention to evaluate changes in subjective tinnitus loudness.

  6 months for each participant

Secondary Outcomes (3)

• Tinnitus Distress using Tinnitus Handicap Inventory

  6 months

• Tinnitus distress using Tinnitus Functional Index

  6 months

• Changes in tinnitus loudness

  6 months

Other Outcomes (1)

• Changes in source localized power and resting state functional connectivity

  6 months

Study Arms (2)

tDCS and sound therapy active

EXPERIMENTAL

would present active tDCS and sound therapy for 40 minutes

Device: tDCS; Device: sound therapy

tDCS and sound therapy sham

SHAM COMPARATOR

would provide a sham tDCS and sound therapy

Device: tDCS; Device: sound therapy

Interventions

tDCS DEVICE

would provide direct current for 40 minutes in 20 minute interval at 2 mA

Also known as: transcranial direct current stimulation

tDCS and sound therapy active; tDCS and sound therapy sham

sound therapy DEVICE

would provide acoustic ripples along with tDCS

tDCS and sound therapy active; tDCS and sound therapy sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of tinnitus (persistent sound heard in one or both ears that is not coming from an external sound source or actual sounds being generated inside your body such as turbulent blood flow), which has persisted for at least 3 days, and began within the last 8 weeks. You do not need to be aware of the tinnitus all the time, but it must be persistent in the sense that is can always hear it if you listen out for it, and there is not enough other sounds around to mask it.
• Age 18 or over
• The ability to make and communicate an informed choice about whether to take part in the study
• The ability to sit still and comfortably in a comfortable chair for around 1 hour at a time.

You may not qualify if:

• Tinnitus due to a physical sound source in the body, such as turbulent blood flow or muscle contractions in the middle ear.
• Presence of tinnitus over a period of 8 weeks
• Severe or profound hearing loss at high frequencies in the tinnitus ear(s), such that you could not properly hear the sounds used in the study
• Any implanted electronic device, such as a pacemaker, cochlear implant, bone-anchored hearing aid, nerve stimulator, deep brain stimulator or spinal cord stimulator
• Any areas of broken skin on the parts of the scalp where tDCS is applied
• Ménière's disease
• Any abnormality of brain structure (e.g. stroke, tumour), or other neurological disorder (e.g. multiple sclerosis or epilepsy)
• The ongoing use of sedating medications, or certain other nerve- or brain-acting medications
• A current mental health condition of sufficient severity to prevent certain activities of everyday life
• In addition to these criteria, the researcher might have other reasons to suspect that participation is either contraindicated, or might be unsuitable. In such cases, the researcher should discuss these concerns with the potential participant and/or a senior member of the research team. Participation should only proceed if all those involved in these discussions agree it should.

Sponsors & Collaborators

• Newcastle University: lead
• American Tinnitus Association: collaborator

Related Publications (2)

• Vanneste S, Byczynski G, Verplancke T, Ost J, Song JJ, De Ridder D. Switching tinnitus on or off: An initial investigation into the role of the pregenual and rostral to dorsal anterior cingulate cortices. Neuroimage. 2024 Aug 15;297:120713. doi: 10.1016/j.neuroimage.2024.120713. Epub 2024 Jun 27.

  PMID: 38944171 BACKGROUND

• Umashankar A, Gander P, Alter K, Sedley W. Short- and long-term changes in auditory sensitivity and tinnitus distress between acute and chronic tinnitus: Longitudinal observation in a community-based sample. Hear Res. 2025 Jul;463:109299. doi: 10.1016/j.heares.2025.109299. Epub 2025 May 7.

  PMID: 40378541 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• William Sedley, PhD

  Newcastle University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abishek Umashankar, PhD

CONTACT

+447776590118; abishek.umashankar@newcastle.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: principal researcher and participant are blinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 17, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 9, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Tentative from march 2027
• Access Criteria: Access to raw data and study protocols