ClinicalTrials.gg
Not yet recruitingNCT07830069ANTARESUpdated Sep 21, 2026

Advanced Neurofeedback for Tinnitus

An interventional study of Neurofeedback in Tinnitus, Subjective, sponsored by University of Zurich. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University of Zurich · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tinnitus, Subjective

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Keywords

  • Tinnitus
  • Neurofeedback
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Intention to become pregnant during the course of the study
  • Known or suspected drug or alcohol abuse
  • Participation in another study with drug within the 30 days preceding and during the present study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Other
    Real NFB - Sham NFB

    Cross-Over Design, starting with real neurofeedback followed by sham neurofeedback

    Other: Neurofeedback

  • Other
    Sham NFB - Real NFB

    Cross-Over Design, starting with sham neurofeedback followed by real neurofeedback

    Other: Neurofeedback

Interventions

  • OtherNeurofeedback

    individualized, norm-based EEG neurofeedback

06

What researchers measure

Primary outcomes

  1. Behavioral - Minimal Masking Level

    Changes in tinnitus intensity measured with audiometric testing: \- MML (Minimal Masking Level) in dB SL

    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)

  2. 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

    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)

  3. Behavioral - Tinnitus Functional Index

    Changes of tinnitus intensity and distress measured with questionnaires: \- TFI (Tinnitus Functional Index) with a score between 0 and 100

    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)

  4. Behavioral - Tinntitus Handicap Inventory

    Changes of tinnitus intensity and distress measured with questionnaires: \- THI (Tinntitus Handicap Inventory) with a score between 0 and 100

    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)

Secondary outcomes

  1. Neurophysiological - neural features

    Changes in individually-defined neural targets, so called neural features (e.g., EEG power, connectivity)

    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)

  2. Neurophysiological - Correlation between the behavioral changes and neurophysiological changes.

    Correlation between the behavioral changes (NRS, TFI, THI) 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07830069
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Tobias Kleinjung, Prof. Dr. med.
Contact
tobias.kleinjung@usz.ch
+41 44 255 58 55

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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