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

NCT06880367 | Recruiting

• 1 other identifier: CHUO-2024-18
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus, Subjective

Keywords

Subjective tinnitus; neuromodulation; audio-proprio-phonatory reinforcement; high-density electroencephalogram

Outcome Measures

Primary Outcomes (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.

  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.

  Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days) of the study.

Secondary Outcomes (13)

• 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

  Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)

• Study the stability over time of quality of life (THI score) after APPR training.

  Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)

• Study the stability over time of tinnitus-related discomfort (VAS) after APPR training.

  Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)

• Describe the evolution of quality of life (THI score) during the study

  Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)

• Describe the evolution of other collateral discomfort (noise) to tinnitus of patients who followed APPR training, compared to patients without APPR training

  Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

The intervention is an audio-proprio-phonatory training BEHAVIORAL

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

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

high-density electroencephalogram (HD-EEG) DIAGNOSTIC_TEST

HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min).

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

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHU Orleans

Orléans, 45067, France

RECRUITING

Related Publications (5)

• Norena AJ. An integrative model of tinnitus based on a central gain controlling neural sensitivity. Neurosci Biobehav Rev. 2011 Apr;35(5):1089-109. doi: 10.1016/j.neubiorev.2010.11.003. Epub 2010 Nov 19.

  PMID: 21094182 BACKGROUND

• Tonndorf J. The analogy between tinnitus and pain: a suggestion for a physiological basis of chronic tinnitus. Hear Res. 1987;28(2-3):271-5. doi: 10.1016/0378-5955(87)90054-2.

  PMID: 2820913 BACKGROUND

• 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.

  PMID: 23597755 BACKGROUND

• 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.

  PMID: 34180194 BACKGROUND

• 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.

  PMID: 38944171 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle Dr MARIE-BAILLY, PhD

  CHU Orléans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Dr MARIE-BAILLY, PhD

CONTACT

2 38 74 43 28; isabelle.marie-bailly@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Neurology staff performing the HD EEG examination will not know the treatment arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 17, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (1)