Status:
RECRUITING
Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
Tinnitus, Subjective
Eligibility:
All Genders
18-84 years
Phase:
NA
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). ...
Detailed Description
Three visits will be conducted, with intervals of two periods lasting five weeks each. Inclusion visit (T0): Following the assessment of eligibility, the patient will receive an informative document ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2028
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06880367
Start Date
March 18 2025
End Date
September 18 2028
Last Update
December 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Orleans
Orléans, France, 45067