Tinnitus, SubjectivePHONACOUNCT06880367
Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
A study testing The intervention is an audio-proprio-phonatory training and high-density electroencephalogram (HD-EEG) in people with Tinnitus, Subjective, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- The intervention is an audio-proprio-phonatory training and high-density electroencephalogram (HD-EEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2025to 18 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Orleans
Orléans, 45067
Isabelle Dr MARIE-BAILLY, PhD, 238744328 ext. +33, isabelle.marie-bailly@chu-orleans.fr
About this study
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.
Read the 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.
- Conditions
- Tinnitus, Subjective
- Being tested
- The intervention is an audio-proprio-phonatory training, high-density electroencephalogram (HD-EEG)
- Keywords
- Subjective tinnitus, neuromodulation, audio-proprio-phonatory reinforcement, high-density electroencephalogram
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention is an audio-proprio-phonatory trainingBehavioural
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
high-density electroencephalogram (HD-EEG)Diagnostic test
HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: The intervention is an audio-proprio-phonatory training; Diagnostic Test: high-density electroencephalogram (HD-EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Visual analog scale of discomfort (VAS-D) tinnitus (scale from 0 to 10 with 10 being the worst score), completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), 4 times per week.
- For the group with APPR training between T0 and T1, they will be completed : morning and evening, on the day of the group workshops (Monday or Tuesday) and on Friday
- For the group without APPR training between T0 et T1, they will be completed : upon waking up and in the evening, every Monday and Friday.
This will first involve comparing the average of the daily differences obtained over 5 weeks . Then we will compare the evolution (taking the daily average of the tinnitus VAS-D) over 5 weeks between T0 et T1 for the 2 groups.
NB : These results can be confirmed bu analyzing the tinnitus VAS-D over the 5 weeks between T1 (Day 42) and T2 (Day 92) for group B (having the APPR training over this period.
Measured: 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.
To study stability over time, only data from patients in group A, without APPR training between T1 (Day 42) et T2 (Day 92) will be used :
- The THI score (scale from 0 to 100 with 10 being the worst score) measured at T1 and T2 This will involve comparing the results at T2 compared to T1.
Measured: 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.
To study stability over time, only data from patients in group A, without APPR training between T1 (Day 42) et T2 (Day 92) will be used :
- VAS-D tinnitus scale (scale from 0 to 10 with 10 being the worst score), completed by te patient (on the Siopi application), weekly between T1 and T2, 4 times per week.
Measured: 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
Evolution over time of the THI score (scale from 0 to 100 with 10 being the worst score) measured at T0 (Day 0), T1 (Day 42) and T2 (Day 92) for the 2 groups.
Measured: 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
Visual analog scale VAS-D (scale from 0 to 10 with 10 being the worst score) associated questions about noises, completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), at a rate of 4 times per week, for the 2 groups. We will compare the evolution of each VAS-D taken independantly, taking the daily average of VAS-D concerned, over the 5 weeks between T0 and T1 for the 2 groups.
Measured: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (cervical pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Visual analog scale VAS-D (scale from 0 to 10 with 10 being the worst score) associated questions with cervical pain completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), at a rate of 4 times per week, for the 2 groups. We will compare the evolution of each VAS-D taken independantly, taking the daily average of VAS-D concerned, over the 5 weeks between T0 and T1 for the 2 groups.
Measured: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (jaw pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Visual analog scale VAS-D (scale from 0 to 10 with 10 being the worst score) associated questions with jaw pain completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), at a rate of 4 times per week, for the 2 groups. We will compare the evolution of each VAS-D taken independantly, taking the daily average of VAS-D concerned, over the 5 weeks between T0 and T1 for the 2 groups.
Measured: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (sleep) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Visual analog scale VAS-D (scale from 0 to 10 with 10 being the worst score) associated questions about sleep completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), at a rate of 4 times per week, for the 2 groups. We will compare the evolution of each VAS-D taken independantly, taking the daily average of VAS-D concerned, over the 5 weeks between T0 and T1 for the 2 groups.
Measured: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort(stress-anxiety) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Visual analog scales VAS-D (scale from 0 to 10 with 10 being the worst score) associated questions about stress-anxiety completed by the patient (on the Siopi application), weekly between T0 (Day 0) and T1 (Day 42), at a rate of 4 times per week, for the 2 groups. We will compare the evolution of each VAS-D taken independantly, taking the daily average of VAS-D concerned, over the 5 weeks between T0 and T1 for the 2 groups.
Measured: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Evaluate the effect of APPR training on the usual connectivity of HD-EEG, compared to patients who did not follow APPR training
Exploratory analyzes of the different HD-EEG parameters measured at T0 (Day 0) and T1 (Day 42) in the 2 groups :
The evolution of HD-EEG connectivity such as : network efficiency, dwill be described in the group with APPR training and compared to the evolution of this same parameter in the group without APPR training between T0 and T1.
Measured: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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
Exploratory analyzes of the different HD-EEG parameters measured at T0 (Day 0) and T1 (Day 42) in the 2 groups :
The evolution of HD-EEG microstate parameters such as : duration of states, will be described in the group with APPR training and compared to the evolution of this same parameter in the group without APPR training between T0 and T1.
Measured: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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
Exploratory analyzes of the different HD-EEG parameters measured at T0 (Day 0) and T1 (Day 42) in the 2 groups :
The evolution of HD-EEG connectivity and microstate parameters such as : distribution of states, will be described in the group with APPR training and compared to the evolution of this same parameter in the group without APPR training between T0 and T1.
Measured: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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.
Exploratory analyzes of the search for correlation between evolution of connectivity parameters of HD-EEG (determine specific parameters like distribution of states) with the evolution of THI score (scale from 0 to 100 with 100 being the worst score) will be explored (between T0 and T1)
Measured: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start18 Mar 2025
- Primary completion18 Sep 2028 (estimated)
- Study completion18 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Dr MARIE-BAILLY, PhD, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880367
- Sponsor's protocol ID
- CHUO-2024-18
- Acronym
- PHONACOU
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21094182Tonndorf 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.
PubMed 2820913De 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.
PubMed 23597755Huang 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.
PubMed 34180194Vanneste 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.
PubMed 38944171
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
- ClinicalTrials.gov ID
- NCT06880367
- Acronym / sponsor ID
- PHONACOU / CHUO-2024-18
- Conditions
- Tinnitus, Subjective
- Keywords
- Subjective tinnitus, neuromodulation, audio-proprio-phonatory reinforcement, high-density electroencephalogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 18 Sep 2028 (estimated)
- Study completion
- 18 Sep 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1: audio-proprio-phonatory training (phase 1) then no training (phase 2) | Experimental | Behavioral: The intervention is an audio-proprio-phonatory training, Diagnostic Test: high-density electroencephalogram (HD-EEG)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. |
| Group 2: No training (phase 1) then audio-proprio-phonatory training (phase 2) | Experimental | Behavioral: The intervention is an audio-proprio-phonatory training, Diagnostic Test: high-density electroencephalogram (HD-EEG)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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention is an audio-proprio-phonatory trainingThe 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 | Behavioural | 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)HD-EEG examination with 256 channels distributed throughout the skull that record resting brain connectivity(10 min). | Diagnostic test | 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) |
Primary outcome
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.
Time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days) of the study.
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.
13 secondary outcomes
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (cervical pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Time frame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (jaw pain) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Time frame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort (sleep) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Time frame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Describe the evolution of other collateral discomfort(stress-anxiety) to tinnitus of patients who followed APPR training, compared to patients without APPR training
Time frame: Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
Evaluate the effect of APPR training on the usual connectivity of HD-EEG, compared to patients who did not follow APPR training
Time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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
Time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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
Time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
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.
Time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Background: PubMed 21094182Norena 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.
- Background: PubMed 2820913Tonndorf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Dr MARIE-BAILLY, PhD principal investigator
CHU Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention is an audio-proprio-phonatory training and high-density electroencephalogram (HD-EEG) in people with Tinnitus, Subjective, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dr MARIE-BAILLY, PhD (2 38 74 43 28 ext. +33, isabelle.marie-bailly@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days) of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880367, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.