Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG) (PHONACOU)

Centre Hospitalier Régional d'Orléans

Status: Enrolling

Conditions: Tinnitus, Subjective

Treatments: Behavioral: The intervention is an audio-proprio-phonatory training; Diagnostic Test: high-density electroencephalogram (HD-EEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06880367

CHUO-2024-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Group 1: audio-proprio-phonatory training (phase 1) then no training (phase 2)

Experimental group

Description:

Patients will undergo audio-proprio-phonatory training and evaluate their discomfort using the VAS-D scale for a duration of five weeks. Following this period, they will be assessed with the THI score and undergo HD EEG examination (T1). Subsequently, there will be no training and patients will again evaluate their discomfort using the VAS-D score over the next five weeks. At the conclusion of the ten weeks of follow-up, patients will be assessed with the THI score.

Treatment:

Diagnostic Test: high-density electroencephalogram (HD-EEG)

Behavioral: The intervention is an audio-proprio-phonatory training

Group 2: No training (phase 1) then audio-proprio-phonatory training (phase 2)

Experimental group

Description:

Patients will be no training and evaluate their discomfort using the VAS-D scale for a duration of five weeks. Following this period, they will be assessed with the THI score and undergo HD EEG examination (T1). Subsequently, there will undergo audio-proprio-phonatory training and patients will again evaluate their discomfort using the VAS-D score over the next five weeks. At the conclusion of the ten weeks of follow-up, patients will be assessed with the THI score.

Treatment:

Diagnostic Test: high-density electroencephalogram (HD-EEG)

Behavioral: The intervention is an audio-proprio-phonatory training