AUDISSEE-Evaluation of a New Digital Therapy of a Cognitive Auditory Training
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Hearing in noise
研究概览
简要总结
The aim of the study is to evaluate the efficiency of the medical device AUDISSEE in improving the perception in noise ability of presbycusis patients with hearing-aids.
详细描述
AUDISSEE is a digital therapy designed specifically to improve the hearing in noise of presbycusis patients by offering a complete cognitive auditory training, with verbal and non-verbal (especially musical) stimuli. This therapy is designed improve the comfort of life of people fitted with hearing aids by improving the observance of the wearing of their hearing aids. It is designed for the greatest number of people regardless of age or type of hearing aids and adapts to all levels of hearing loss (mild to severe).
In this study, 240 patients will be randomized in four groups. The first group will be trained with AUDISSEE-verbal, AUDISSE-non-verbal then with the placebo therapy. The second group will be trained with AUDISSEE-non-verbal, AUDISSEE-verbal, then with the placebo therapy. The third group will be trained with the placebo therapy then AUDISSEE-verbal, and AUDISSE-non-verbal. The fourth group will be trained with the placebo therapy then AUDISSEE-non-verbal, and AUDISSE-verbal.
Each training session will last 20 minutes. 3 sessions are planned per week, for 5 weeks for each sub-training. The protocol lasts 20 weeks in total for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The training will be performed at home. The investigators/evaluators will send a download link of the therapy to the patients without knowing which therapy it corresponds to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •No neurological or psychiatric background
- •No major cognitive deficit, able to understand and apply the recommendation
- •Motivated to participate
- •Have given its written consent
- •Affiliated to a social security system
- •Diagnostic of presbycusis by a health professional
- •Hearing-aids since less than 2 years (no cochlear implants)
- •No tinnitus
- •With a possible access to a personal computer, tactile tablet or smart-phone to perform the training
排除标准
- •Age below 18
- •Pregnant or breastfeeding women
结局指标
主要结局
Hearing in noise
时间窗: 20 weeks to baseline
Measure of speech-in-noise comprehension using vocal audiometry (FrBio): Using SpeechNoise and a SNR (Signal-to-Noise Ratio) of 5dB, a percentage of correct repetition of 20 sentences is measured
次要结局
- Quality of life and hearing : listening effort(5 weeks to baseline)
- Non-verbal auditory testing :pitch change detection task(5 weeks to baseline)
- Quality of life and hearing : personal efficacy(5 weeks to baseline)
- Non-verbal auditory testing: Auditory Streaming separation task(20 weeks to baseline)
- Quality of life and hearing : spatial learning abilities(5 weeks to baseline)
- Quality of life and hearing: spatial learning abilities(20 weeks to baseline)
- Non-verbal auditory testing: Emotional prosody recognition task(20 weeks to baseline)
- Quality of life and hearing: personal efficacy(20 weeks to baseline)
- Quality of life and hearing: listening effort(20 weeks to baseline)
- Non-verbal auditory testing: Direction of pitch change identification task(20 weeks to baseline)
- Non-verbal auditory testing: Short term memory for pitch task(20 weeks to baseline)
- Non-verbal auditory testing: Pitch Change Detection task(20 weeks to baseline)