Training to help manage subjective tinnitus using sound and self-phonation
Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
This study tests if a new training method using sound and voice exercises can help people with chronic tinnitus feel better by masking their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Régional d'Orléans Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT06880367 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of audio-proprio-phonatory reinforcement training on individuals suffering from chronic subjective tinnitus. Participants will engage in self-phonation exercises to create sound stimuli that may help mask their tinnitus, while their brain activity is monitored using high-density electroencephalography (HD EEG). The study involves two groups that will alternate between training and no training phases, with assessments conducted at multiple visits to evaluate the impact of the intervention on tinnitus symptoms and brain connectivity. The goal is to quantify the therapeutic effects of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have been experiencing subjective tinnitus for more than three months.
Not a fit: Patients with objective tinnitus or those currently using white noise generators may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, self-managed method for alleviating tinnitus symptoms.
How similar studies have performed: While the specific approach of audio-proprio-phonatory reinforcement is novel, similar neuromodulatory techniques have shown promise in managing tinnitus in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Orléans
- CHU Orleans — Orléans, France (Recruiting)
Study contacts
- Principal investigator: Isabelle Dr MARIE-BAILLY, PhD — CHU Orléans
- Study coordinator: Isabelle Dr MARIE-BAILLY, PhD
- Email: isabelle.marie-bailly@chu-orleans.fr
- Phone: 2 38 74 43 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.