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NCT Number: NCT07830069

Advanced Neurofeedback for Tinnitus

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

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 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

Treatment and study plan

Neurofeedback

Other

individualized, norm-based EEG neurofeedback

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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)

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

  2. 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)

    Correlation between the behavioral changes (NRS, TFI, THI) and neurophysiological changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Tobias Kleinjung, Prof. Dr. med.

CONTACT

[email protected]

+41 44 255 58 55

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Advanced Neurofeedback for Tinnitus Applying Representational EEG Signatures

Acronym: ANTARES

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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