Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
The intervention is an audio-proprio-phonatory traininghigh-density electroencephalogram (HD-EEG)
The 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
high-density electroencephalogram (HD-EEG): HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min).
Study 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
Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
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
Primary outcome measure(s)
The objective is to assess whether training that incorporates audio-proprio-phonatory reinforcement (APPR) can alleviate the daily life disability associated with tinnitus, in comparison to patients who have not undergo APPR training. — Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days) of the study. The international Tinnitus Handicap Inventory (THI) questionnaire will be employed to assess the influence of training on the quality of patients affected by tinnitus.. This assessment will include a comparison of the changes in THI scores from T0 (Day 0) to T1 (Day 42) in the group that underwent APPR training, relative to the changes in THI scores from T0 (Day 0) to T1 (Day 42) in the group that did not receive APPR training.
Trial sites (1)
Facility
City
Region
Status
CHU Orleans
Orléans
France
Recruiting
More Centre Hospitalier Régional d'Orléans trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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