Clinical trial NCT06880367: Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
Official title: Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tinnitus, Subjective
Keywords: Subjective tinnitus
neuromodulation
audio-proprio-phonatory reinforcement
high-density electroencephalogram
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is prospective, randomized into two groups with stratification based on the THI score specifically comparing grade 3 to grades 4 and 5.

The neurology staff conducting the HD EEG examination will remain unaware of the treatment allocation, ensuring a single-blinded design.
Primary purpose: SUPPORTIVE_CARE

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.

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 regarding the study. After a period of contemplation, the patient will provide consent to participate.

This visit will include a medical examination, an APPR test accompagnied by spectrogram feedback, a tinnitus assessment focusing on residual inhibition, high-density electroencephalograms and self-assessment questionnaires.

Phase 1: Other the course of five weeks, Group A, designated for"audio-proprio-phonatory training" will participate in one group videoconference session each week, along with daily exercises to complete. Participants will also be required to self-assess using the Visual Analog Scale of discomfort (VAS-D) on the days of the group workshops and on Fridays (both morning and evening).

Concurrently, Group B, labeled "no training" will conduct self-assessments using the VAS-D on Mondays and Fridays (morning and evening).

T1 visit: This visit will involve a medical examination, high-density electroencephalograms and self-assessment questionnaires will be performed.

Phase 2: The 2 groups will switch roles and follow the same protocol as outlined in phase 1.

End of study visit (T2): A medical examination and self-assessment questionnaires will be conducted.

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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Determine whether APPR exercises reduce the discomfort linked to tinnitus in the short term (tinnitus discomfort VAS), compared to patients who have not followed APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Study the stability over time of quality of life (THI score) after APPR training.
timeFrame: Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Study the stability over time of tinnitus-related discomfort (VAS) after APPR training.
timeFrame: Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of quality of life (THI score) during the study
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of other collateral discomfort (noise) to tinnitus of patients who followed APPR training, compared to patients without APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of other collateral discomfort (cervical pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of other collateral discomfort (jaw pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of other collateral discomfort (sleep) to tinnitus of patients who followed APPR training, compared to patients without APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Describe the evolution of other collateral discomfort(stress-anxiety) to tinnitus of patients who followed APPR training, compared to patients without APPR training
timeFrame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
measure: Evaluate the effect of APPR training on the usual connectivity of HD-EEG, compared to patients who did not follow APPR training
timeFrame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
measure: Evaluate the effect of APPR training on the usual connectivity (duration of states) of HD-EEG, compared to patients who did not follow APPR training
timeFrame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
measure: Evaluate the effect of APPR training on the usual microstate parameters (distribution of states) of HD-EEG, compared to patients who did not follow APPR training
timeFrame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
measure: Describe the evolution of the quality of life (THI score) of patients before and after APPR training and the usual connectivity and microstate parameters of HD-EEG, over time.
timeFrame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHU Orleans
Study officials:
affiliation: CHU Orléans
name: Isabelle Dr MARIE-BAILLY, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: De Ridder D, Vanneste S, Weisz N, Londero A, Schlee W, Elgoyhen AB, Langguth B. An integrative model of auditory phantom perception: tinnitus as a unified percept of interacting separable subnetworks. Neurosci Biobehav Rev. 2014 Jul;44:16-32. doi: 10.1016/j.neubiorev.2013.03.021. Epub 2013 Apr 15.
citation: Huang H, Cai Y, Feng X, Li Y. [An electroencephalogram-based study of resting-state spectrogram and attention in tinnitus patients]. Sheng Wu Yi Xue Gong Cheng Xue Za Zhi. 2021 Jun 25;38(3):492-497. doi: 10.7507/1001-5515.202012015. Chinese.
citation: Vanneste S, Byczynski G, Verplancke T, Ost J, Song JJ, De Ridder D. Switching tinnitus on or off: An initial investigation into the role of the pregenual and rostral to dorsal anterior cingulate cortices. Neuroimage. 2024 Aug 15;297:120713. doi: 10.1016/j.neuroimage.2024.120713. Epub 2024 Jun 27.