Comparison of Synchronous or Delayed Speech Therapy and Audioprosthetic Care in Older Adults With First-time Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 66
- 主要终点
- Assessment of the Impact of Deafness in Adults
研究概览
简要总结
The purpose of the study is to evaluate the score of the Evaluation of the Impact of Deafness in Adults(ERSA)/150 questionnaire obtained at 3 months compared to the inclusion score.
详细描述
This is a pilot, prospective, interventional, comparative, randomized, longitudinal, open, multicenter study comparing synchronous and delayed hearing aid and speech therapy.
Patients will be randomly divided by drawing lots into 2 groups. Both groups will benefit from a hearing aid prescription and speech therapy for a series of 24 sessions at the rate of 1 per week, for an approximate duration of 6 months. Group A will benefit from speech therapy and synchronous equipment, and group B will begin speech therapy after 3 months after the installation of the equipment.
Regarding the equipment, it will not be the same for all patients. Indeed, it is the one that will best suit the patient who will be chosen. The same will apply to the settings, in accordance with the usual support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, male or female, aged 65 to 80;
- •First equipment;
- •Average hearing loss between 40 and 70 db;
- •Speech comprehension greater than 50%;
- •Absence of acoustic recruitment phenomenon;
- •Symmetrical bilateral deafness (inter aural difference <20dB);
- •Affiliated patient or beneficiary of a social security scheme;
- •Patient speaking and understanding French, able to complete questionnaires and scales;
- •Patient having been informed and having signed an informed consent to participate in the study.
排除标准
- •Patient with a psychiatric pathology;
- •Patient with neurological disorders;
- •Patient taking psychotropic drugs;
- •Patient participating in another clinical study;
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
- •Patient hospitalized without consent.
结局指标
主要结局
Assessment of the Impact of Deafness in Adults
时间窗: 3 months
Score of the questionnaire "Assessment of the Impact of Deafness in Adults" obtained at 3 months compared to the inclusion score. The ERSA (Evaluation of the Repercussions of Deafness in Adults) assesses four areas: quality of life, personal life, social life and professional life. It is rated out of 200 or out of 150 in the absence of professional life. The higher the ERSA score, the better the patient's quality of life.
次要结局
未报告次要终点