Actively Recruiting

Phase Not Applicable
Age: 18Years - 84Years
All Genders
NCT06880367

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

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30

56

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 84Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Agreed to participate and provided consent
  • Aged 18 years or older and younger than 85 years
  • Have subjective tinnitus for more than 3 months
  • Score of 38 or higher on the THI questionnaire at study start
  • Own a smartphone compatible with the Siopi application and have computer internet access for videoconferences
  • Completed the THI, VAS-D, and insomnia severity index questionnaires on the Siopi app
  • Committed to following the study protocol, including independent training
  • Agreed not to start any new tinnitus treatments during the study
  • Able to understand and complete assessment instructions
Not Eligible

You will not qualify if you...

  • Suffering from objective tinnitus
  • Currently using white noise generators
  • Have consulted a phoniatrics specialist more than twice or participated in more than two sound therapy workshops
  • Have bilateral hearing loss over 40 dB uncorrected or severe hearing loss with or without hearing aids
  • Started a new therapy less than 2 months ago
  • Have psychiatric disorders causing auditory hallucinations
  • Under guardianship, curatorship, judicial protection, or deprived of liberty
  • Not affiliated with a social security system
  • Pregnant or breastfeeding
  • Participating in another drug study

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU Orleans

Orléans, France, 45067

Actively Recruiting

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Research Team

I

Isabelle Dr MARIE-BAILLY, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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