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Search / Trial NCT06880367

Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)

Launched by CENTRE HOSPITALIER RÉGIONAL D'ORLÉANS · Mar 11, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

Subjective Tinnitus Neuromodulation Audio Proprio Phonatory Reinforcement High Density Electroencephalogram

ClinConnect Summary

This clinical trial is exploring a new way to help people who experience tinnitus, which is a ringing or buzzing sound in the ears that isn’t caused by an outside source. The study focuses on a method called audio-proprio-phonatory reinforcement training, where participants will learn to create their own sounds to help mask the noise of their tinnitus. By using high-definition EEG technology, researchers will look at how this training affects brain activity and connectivity, helping to understand its benefits for those suffering from chronic tinnitus.

To participate in this trial, individuals must be between 18 and 85 years old and have had tinnitus for more than three months. They will need to have a smartphone that works with the study app and be willing to follow the training protocol independently. Participants should not be receiving other tinnitus treatments during the study and must be able to complete assessments and training sessions. This trial not only aims to offer a new approach to managing tinnitus but also seeks to empower individuals to take control of their condition through sound production.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Person who agreed to participate in the study and gave consent
  • Aged ≥ 18 years and \< 85 years
  • Suffering from subjective tinnitus for more than 3 months
  • Have a score on the THI questionnaire taken at T0 greater than or equal to 38
  • Be equipped with a smartphone compatible with the Siopi application and a computer connection for videoconference sessions
  • Have answered the questionnaires on the Siopi application: THI, VAS-D and associated questions and insomnia severity index
  • Have committed to diligently following the study protocol, including independent training
  • Have agreed not to take other new treatments for tinnitus throughout the duration of the study
  • Able to understand and carry out assessment instructions.
  • Exclusion Criteria:
  • Patient suffering from objective tinnitus
  • Current port of white noise generators
  • Patient having consulted phoniatrics more than twice or having participated in more than two sound-mediated workshop sessions
  • Bilateral hearing loss \> 40 dB uncorrected on an audiogram or having declared serious or severe hearing loss on Siopi questionnaire, with or without prosthetic correction
  • New therapy introduced less than 2 months ago
  • Psychatric disorders causing auditory hallucinations
  • Protected person (under guardianship or curatorship)
  • Person under judicial protection
  • Person deprived of liberty
  • Person not affiliated to a social security system
  • Pregnant or breastfeeding woman
  • Person participating in a drug study

About Centre Hospitalier Régional D'orléans

The Centre Hospitalier Régional d'Orléans is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Located in Orléans, France, the center is committed to fostering a collaborative environment that integrates clinical expertise with cutting-edge research methodologies. By facilitating multidisciplinary studies across various therapeutic areas, the Centre Hospitalier Régional d'Orléans aims to enhance treatment protocols and contribute to the global body of medical knowledge, ultimately benefiting patients and the healthcare community at large.

Locations

Orléans, , France

Patients applied

0 patients applied

Trial Officials

Isabelle Dr MARIE-BAILLY, PhD

Principal Investigator

CHU Orléans

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported