RecruitingNot ApplicableNCT06880367

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


Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

56 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Our ecological approach to neuromodulation in the field of "acouphonology" empowers tinnitus patients to act as their own source of sound stimuli through audio-proprio-phonatory reinforcement (APPR). By engaging in self-phonations, individuals uncoverthe vast potential for sound production, which can effectively mask their tinnitus or induce residual inhibition, all without relying on external sources. This clinical study aims to illustrate the positive impact of audio-proprio-phonatory reinforcement training on individuals suffering from chronic subjective tinnitus. This will be further supported and quantified through high-definition electroencephalography (HD EEG) as we explore the relationship between changes in connectivity within specific brain regions and the varying degrees of response to the therapeutic protocol.


Eligibility

Min Age: 18 YearsMax Age: 84 Years

Inclusion Criteria9

  • 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 Criteria12

  • 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

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Interventions

BEHAVIORALThe intervention is an audio-proprio-phonatory training

The audio-proprio-phonatory training involves engaging in group workshops and performing exercise sessions independently, following the guidance provided by the specialist, over a duration of five weeks

DIAGNOSTIC_TESThigh-density electroencephalogram (HD-EEG)

HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min).


Locations(1)

CHU Orleans

Orléans, France

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NCT06880367


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