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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorCentre Hospitalier Régional d'Orléans

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

  • high-density electroencephalogram (HD-EEG)

    Diagnostic test

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Group 1: audio-proprio-phonatory training (phase 1) then no training (phase 2)Experimental treatment 2 interventions
Group B: Group 2: No training (phase 1) then audio-proprio-phonatory training (phase 2)Experimental treatment 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Evaluation at T0 (Day 0), T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
2

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.

Time frame
Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
3

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.

Time frame
Evaluation at T1 (Day 42 +/- 7 days) and T2 (Day 92 +/- 7 days)
4

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.

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

Other outcomes

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