NCT07830069

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jan 2027

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

April 17, 2026

Last Update Submit

September 14, 2026

Conditions

Tinnitus, Subjective

Keywords

TinnitusNeurofeedback

Outcome Measures

Primary Outcomes (4)

  • Behavioral - Minimal Masking Level

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

    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

    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

    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

    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

    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.

    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)

Study Arms (2)

Real NFB - Sham NFB

OTHER

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

Other: Neurofeedback

Sham NFB - Real NFB

OTHER

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

Other: Neurofeedback

Interventions

NeurofeedbackOTHER

individualized, norm-based EEG neurofeedback

Real NFB - Sham NFBSham NFB - Real NFB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Tobias Kleinjung, Prof. Dr. med.

CONTACT

+41 44 255 58 55tobias.kleinjung@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

September 21, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 21, 2026

Record last verified: 2026-09