Neuromodulatory Effects of Audio-proprio-phonatory Reinforcement Training on Subjective Tinnitus, Demonstrated by High-density Electroencephalogram (HD EEG)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Neurology staff performing the HD EEG examination will not know the treatment arm.
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- Describe the evolution of other collateral discomfort (sleep) 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))
- 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))
- Describe the evolution of other collateral discomfort (cervical pain) 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))
- Describe the evolution of other collateral discomfort (jaw pain) 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))
- Describe the evolution of other collateral discomfort(stress-anxiety) 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))
- Evaluate the effect of APPR training on the usual connectivity of HD-EEG, compared to patients who did not follow APPR training(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(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(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.(Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days))
- 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))
- Describe the evolution of other collateral discomfort (cervical pain) 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))
- Describe the evolution of other collateral discomfort (jaw pain) 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))
- Describe the evolution of other collateral discomfort (sleep) 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))
- Describe the evolution of other collateral discomfort(stress-anxiety) 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))
- 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(Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days))
- Evaluate the effect of APPR training on the usual connectivity of HD-EEG, compared to patients who did not follow APPR training(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.(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(Evaluation at T0 (Day 0) and T1 (Day 42 +/- 7 days))