Tinnitus, SubjectiveANTARESNCT07830069
Advanced Neurofeedback for Tinnitus
A study testing Neurofeedback in people with Tinnitus, Subjective, run by University of Zurich.
Trial summary
This study investigates neurofeedback as a potential treatment for chronic tinnitus. Neurofeedback is a non-invasive method that aims to regulate brain activity and may help reduce tinnitus symptoms and the distress associated with them. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female or male or diverse patients 18 years to 65 years of age
- Persistent chronic, subjective tinnitus with duration of more than 3 months
- Signed informed consent after being informed about the study
- Fluent in German
- Tinnitus with a THI Grade 2 to 4 (18-76 points), moderate to severe
- Willing and able to attend all study visits
Who cannot join
- Hyperacusis
- Concurrent neurological or psychiatric disorders
- Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)
- Somatic tinnitus
- Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss > 40dB in any measured frequency up to 2kHz
- Women who are pregnant and/or breast feeding
Show all 10Show fewer
- Intention to become pregnant during the course of the study
- Known or suspected drug or alcohol abuse
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Advanced Neurofeedback for Tinnitus Applying Representational EEG Signatures
This study investigates neurofeedback as a potential treatment for chronic tinnitus. Neurofeedback is a non-invasive method that aims to regulate brain activity and may help reduce tinnitus symptoms and the distress associated with them. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of this treatment.
The study duration is approximately nine months, including follow-up assessments. Participants attend 25 study visits, consisting of 20 neurofeedback treatment sessions and 5 assessment appointments. The study follows a randomized, placebo-controlled crossover design, meaning all participants receive both active neurofeedback and placebo neurofeedback in different sequences. The placebo provides feedback that is not based on real-time brain activity and serves as a control to ensure reliable scientific results.
Read more
Direct personal benefits cannot be guaranteed; however, participation may contribute to improved understanding and future treatment of tinnitus. A reduction in tinnitus symptoms is possible.
Neurofeedback is an established and safe, non-invasive technique. The specific method examined in this study is newly developed and has not yet been tested. Although no significant side effects are currently known, unforeseen risks cannot be entirely excluded. Overall, the study is classified as a low-risk clinical trial.
- Conditions
- Tinnitus, Subjective
- Being tested
- Neurofeedback
- Keywords
- Tinnitus, Neurofeedback
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
individualized, norm-based EEG neurofeedback
| Study group | Role | What they receive |
|---|---|---|
| Real NFB - Sham NFB | Other | Cross-Over Design, starting with real neurofeedback followed by sham neurofeedback Receives: Other: Neurofeedback |
| Sham NFB - Real NFB | Other | Cross-Over Design, starting with sham neurofeedback followed by real neurofeedback Receives: Other: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral - Minimal Masking Level
Changes in tinnitus intensity measured with audiometric testing:
- MML (Minimal Masking Level) in dB SL
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Numeric Rating Scale
Changes of tinnitus intensity and distress measured with questionnaires:
- NRS (Numeric Rating Scale) on a 11- point Likert scale from 0 to 10
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Tinnitus Functional Index
Changes of tinnitus intensity and distress measured with questionnaires:
- TFI (Tinnitus Functional Index) with a score between 0 and 100
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Behavioral - Tinntitus Handicap Inventory
Changes of tinnitus intensity and distress measured with questionnaires:
- THI (Tinntitus Handicap Inventory) with a score between 0 and 100
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Secondary outcomes (2)
Neurophysiological - neural features
Changes in individually-defined neural targets, so called neural features (e.g., EEG power, connectivity)
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Neurophysiological - Correlation between the behavioral changes and neurophysiological changes.
Correlation between the behavioral changes (NRS, TFI, THI) and neurophysiological changes.
Measured: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830069
- Sponsor's protocol ID
- 2025-01839
- Other IDs
- 2025-01839, 2025
- Acronym
- ANTARES
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Neurofeedback for Tinnitus Applying Representational EEG Signatures
- ClinicalTrials.gov ID
- NCT07830069
- Acronym / sponsor ID
- ANTARES / 2025-01839
- Conditions
- Tinnitus, Subjective
- Keywords
- Tinnitus, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates neurofeedback as a potential treatment for chronic tinnitus. Neurofeedback is a non-invasive method that aims to regulate brain activity and may help reduce tinnitus symptoms and the distress associated with them. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of this treatment.
The study duration is approximately nine months, including follow-up assessments. Participants attend 25 study visits, consisting of 20 neurofeedback treatment sessions and 5 assessment appointments. The study follows a randomized, placebo-controlled crossover design, meaning all participants receive both active neurofeedback and placebo neurofeedback in different sequences. The placebo provides feedback that is not based on real-time brain activity and serves as a control to ensure reliable scientific results.
Direct personal benefits cannot be guaranteed; however, participation may contribute to improved understanding and future treatment of tinnitus. A reduction in tinnitus symptoms is possible.
Neurofeedback is an established and safe, non-invasive technique. The specific method examined in this study is newly developed and has not yet been tested. Although no significant side effects are currently known, unforeseen risks cannot be entirely excluded. Overall, the study is classified as a low-risk clinical trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real NFB - Sham NFB | Other | Other: NeurofeedbackCross-Over Design, starting with real neurofeedback followed by sham neurofeedback |
| Sham NFB - Real NFB | Other | Other: NeurofeedbackCross-Over Design, starting with sham neurofeedback followed by real neurofeedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy female or male or diverse patients 18 years to 65 years of age
- Persistent chronic, subjective tinnitus with duration of more than 3 months
- Signed informed consent after being informed about the study
- Fluent in German
- Tinnitus with a THI Grade 2 to 4 (18-76 points), moderate to severe
Key exclusion criteria (10 listed)
- Hyperacusis
- Concurrent neurological or psychiatric disorders
- Regular intake of medication influencing the central nervous system (e.g. neuroleptics, hypnotics, sedatives, and anti-epileptics)
- Somatic tinnitus
- Asymmetrical hearing (more than 20dB side difference), pantonal hearing loss > 40dB in any measured frequency up to 2kHz
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedbackindividualized, norm-based EEG neurofeedback | Other | Real NFB - Sham NFB, Sham NFB - Real NFB |
Primary outcome
Behavioral - Minimal Masking Level
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes in tinnitus intensity measured with audiometric testing: - MML (Minimal Masking Level) in dB SL
Behavioral - Numeric Rating Scale
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: - NRS (Numeric Rating Scale) on a 11- point Likert scale from 0 to 10
Behavioral - Tinnitus Functional Index
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: - TFI (Tinnitus Functional Index) with a score between 0 and 100
Behavioral - Tinntitus Handicap Inventory
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Changes of tinnitus intensity and distress measured with questionnaires: - THI (Tinntitus Handicap Inventory) with a score between 0 and 100
2 secondary outcomes
Neurophysiological - neural features
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Neurophysiological - Correlation between the behavioral changes and neurophysiological changes.
Time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Tinnitus, Subjective, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Kleinjung, Prof. Dr. med. (+41 44 255 58 55, tobias.kleinjung@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral - Minimal Masking Level (time frame: Difference between Baseline (day 0) and: - after treatment block 1(day 29) - after wash-out period 1 and before treatment block 2 (day 113) - after treatment block 2 (day 143) - after wash-out period 2 (day 227)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.