Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Average functional hearing gain
研究概览
简要总结
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.
Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.
详细描述
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.
No patients will be implanted with a Bonebridge as part of the study.
Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.
Questionnaires consist of the AQol-8D and the SSQ-12
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with a Bonebridge device and are active users
- •Unilateral and/or bilateral conductive hearing loss (CHL)
- •Subjects aged 13 years or older
- •Capable of the German language
- •Willingness and ability to perform all tests required for the study
- •Signed, and dated informed consent before the start of any study specific procedure
排除标准
- •Pregnancy or breastfeeding
- •Patient is intolerant of the materials as described by Manufacturer's IFU
- •Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- •Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
- •Patient presents with retrocochlear, or central auditory disorder.
- •any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
结局指标
主要结局
Average functional hearing gain
时间窗: 3 weeks
The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.
次要结局
- AQoL-8D (quality of life)(3 weeks)
- Quality of hearing(3 weeks)
- Word recognition score(3 weeks)
- Sentence test(3 weeks)
研究者
Dominik Riss
Assoc. Prof PD Dr.
Medical University of Vienna