Hearing Handicap in Patients With Single Sided Deafness
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Tinnitus handicap inventory (THI)
研究概览
简要总结
Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant worsening of hearing in one ear compared to the other.
In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new SSD patients being referred every year.
Only a small number of studies have explored hearing handicap for those with SSD, and music appreciation has not been investigated, to the best of the investigators knowledge, in this patient group.
In the limited number of studies conducted on those with single sided deafness, often only one or two outcome measures have been used, or the patient group has been small. The investigators have a large group of patients with a wide range of aetiologies who have completed several questionnaires as part of their treatment in the single sided deafness clinic and the investigators would like to analyse these data.
At present there are different devices available on the NHS for the management of SSD and many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an under-representation of studies looking specifically at CROS aid devices which is relevant given the cost differences involved between devices.
Study goals and objectives
- To find out what factors drive hearing handicap in SSD patients by analysing the results of several different well validated hearing handicap questionnaires
- To find out whether or not it is possible to change hearing handicap in this patient group by looking to see if there is an improvement in questionnaire scores post treatment.
- The investigators will also look at a sub-group who will be fitted with both traditional wired CROS aids and more up-to-date wireless aids which have been funded through a research grant, in order to assess whether these are more beneficial.
- The investigators will use a new questionnaire developed in-house to further explore the impact of single sided deafness on music appreciation.
详细描述
SSD can lead to:
- Reduction in spatial hearing
- Significant difficulty in background noise and social situations
- Exhaustion from the extra effort required to hear
- Reduced confidence
- Reduced ability to enjoy music
- Isolation
- An emotional burden linked to the onset of the hearing loss and associated symptoms
The investigators have established a specialised clinic to address the consequences of SSD, and assess treatment options including the provision of counselling and wired CROS (Contralateral Routing of Signal) hearing aids.
The investigators use a range of questionnaires, completed pre and post treatment, to assess outcomes and would like to analyse this data to see what drives handicap and whether there is any observable improvement post treatment. The investigators would like to find out more about the impact of SSD on patients' ability to enjoy music and propose to do this using a questionnaire developed in-house.
The investigators have been awarded a grant to fit some of their patients with wireless CROS aids, which are not routinely available under the NHS in Cambridge, but are widely available in other areas and in the commercial sector.
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
- None
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
- •Patients who attend the single sided deafness clinic.
- •Must have either no recordable hearing threshold levels on one side or a significant asymmetry.
- •The 13 CROS aid trial patients must be post-operative vestibular schwannoma patients with an audiological 'dead ear' on the affected side.
排除标准
- •Patients unable to give informed consent
- •Patients under 18 years of age
- •For the CROS aid trial, patients with any aetiology other than vestibular schwanomma, pre-operative vestibular schwanomma patients or vestibular schwanomma patents who still have residual hearing in the affected ear.
结局指标
主要结局
Tinnitus handicap inventory (THI)
时间窗: 180 days
Tinnitus questionnaire
Hearing handicap inventory (HHI)
时间窗: 180 days
Hearing aid benefit questionnaire
Abbreviated hearing aid benefit profile (APHAB)
时间窗: 180 days
Hearing aid benefit questionnaire
Speech and spatial qualities of hearing (SSQ)
时间窗: 180 days
Hearing aid benefit questionnaire
Hospital anxiety and depression scale (HADS)
时间窗: 180 days
Anxiety and depression questionnaire
次要结局
未报告次要终点
研究者
Rachel Knappett
Specialist Audiologist
Cambridge University Hospitals NHS Foundation Trust