Study on the Treatment of Tinnitus with Personalized Brainwave Training (Neurofeedback)
Résumé de l'étude
This study investigates whether a specific training with brainwaves (neurofeedback) can alleviate the complaints of people with persistent ear noise (tinnitus). Participants will attend several sessions over approximately nine months, during which brain activity will be measured using a special cap. Through visual feedback on a screen, participants learn to intentionally influence their brainwaves. A total of 20 training sessions and 5 measurements are planned. The study is designed so that participants receive both active training and a placebo treatment. Neither the participants nor the examiners know which treatment is administered at which time, corresponding to a random assignment like a coin toss. Additionally, hearing tests will be conducted, and questionnaires regarding well-being and tinnitus experience will be used. All procedures are safe and non-invasive. Mild, temporary side effects such as fatigue or headaches may very rarely occur after the sessions. The results of the study aim to contribute to improving the treatment of tinnitus in the future.
(BASEC)
Intervention étudiée
The intervention studied in this research is a personalized neurofeedback therapy (NFB). This is a non-invasive training procedure aimed at the targeted alteration of brain activity patterns associated with chronic tinnitus. An EEG system (BrainProducts actiChamp) with 64 electrodes is used to measure the participants' brainwaves in real-time. A specially developed software analyzes this data and identifies individual, tinnitus-relevant features in the EEG for each participant using machine learning. These personalized features serve as the basis for the training. During the sessions, participants receive visual feedback of their brain activity on a screen, usually in the form of an animation. The goal is for participants to learn to voluntarily control their brainwaves in such a way that the tinnitus-associated patterns normalize. A training session lasts about 15 minutes. The entire study also includes a control condition with a placebo treatment (placebo neurofeedback) to verify the specific effectiveness of the training. The study is conducted in a double-blind manner, so neither participants nor examiners know which treatment is administered.
(BASEC)
Maladie en cours d'investigation
Tinnitus
(BASEC)
Individuals can participate in the study if they meet the following criteria: Healthy women, men, or diverse individuals aged 18 to 65 years; Existing chronic, subjective tinnitus for more than 3 months; Tinnitus burden of grade 2 to 4 (moderate to severe) according to the Tinnitus Handicap Inventory (THI questionnaire with 18–76 points); Fluent German language skills; Willingness and ability to attend all necessary appointments for the study; Signed consent form after comprehensive information about the study. (BASEC)
Critères d'exclusion
Individuals cannot participate in the study if any of the following criteria apply: Concurrent neurological or psychiatric disorders; Regular intake of medications that affect the central nervous system (e.g., antipsychotics, sleeping pills, tranquilizers, or antiepileptics); Presence of hyperacusis (sound sensitivity); Somatic tinnitus (tinnitus influenced by body movements); Asymmetric hearing loss (difference between ears of more than 20 dB) or a pantonal hearing loss of more than 40 dB at frequencies up to 2 kHz; Pregnancy, breastfeeding, or the intention to become pregnant during the study period; Known or suspected drug or alcohol abuse; Participation in another clinical study with an investigational product within the last 30 days before or during the current study; Individuals who are in a dependent relationship with the study management or sponsor (e.g., employees, family members). (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
University and University Hospital of Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Tobias Kleinjung
+41 44 255 58 55
tobias.kleinjung@clutterusz.chUniversity Hospital Zurich Department of Otorhinolaryngology and Head & Neck Surgery Frauenklinikstrasse 24 CH-8091 Zurich Switzerland
(BASEC)
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
20.02.2026
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
ANTARES: Advanced Neurofeedback for Tinnitus Applying Representational EEG Signatures (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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