Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus,… (NCT06880367) | Clinical Trial Compass
RecruitingNot Applicable
Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
France56 participantsStarted 2025-03-18
Plain-language 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.
Who can participate
Age range
18 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days) of the study.