NCT06880367 Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
| NCT ID | NCT06880367 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Tinnitus, Subjective |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2028-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2025-03-18 with a primary completion date of 2028-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Isabelle Dr MARIE-BAILLY, PhD
PRINCIPAL INVESTIGATOR
CHU Orléans
Frequently Asked Questions
Who can join the NCT06880367 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Tinnitus, Subjective. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06880367 currently recruiting?
Yes, NCT06880367 is actively recruiting participants. Contact the research team at isabelle.marie-bailly@chu-orleans.fr for enrollment information.
Where is the NCT06880367 trial being conducted?
This trial is being conducted at Orléans, France.
Who is sponsoring the NCT06880367 clinical trial?
NCT06880367 is sponsored by Centre Hospitalier Régional d'Orléans. The principal investigator is Isabelle Dr MARIE-BAILLY, PhD at CHU Orléans. The trial plans to enroll 56 participants.