Association Between Severe-to-profound Hearing Loss and the Vestibular Function of the Inner Ear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Cervical vestibular evoked myogenic potential (cVEMP).
研究概览
简要总结
Severe-to-profound hearing loss can have a major impact on patients´ lives leading to social isolation and decreased quality of life. Most commonly the hearing loss is caused by damage to the inner ear or cochlear nerve. Since the vestibular system which is central for our balance is located in the inner ear it can be suspected that patients with severe-to-profound hearing loss also might have an impaired vestibular function. This impairment may lead to a feeling of dizziness or vertigo. This study aims to investigate if patients with severe-to-profound hearing loss also have impaired vestibular function. The vestibular function will be measured with caloric irrigation, video head impulse test and vestibular evoked myogenic potential.
详细描述
Background: It is well known that uncorrected hearing loss can lead to increased feeling of exhaustion, social isolation and decreased quality of life. Sensorineural hearing loss originates from a damage to the cochlea in the inner ear or to the cochlear nerve and progresses with increasing age. Severe-to-profound hearing loss (STPHL) is defined as hearing levels 70 dB or worse on the better ear. The Swedish registry for adult patients with STPHL has showed that 30 % of the patients suffer from vertigo or dizziness often or always. The reasons for this are not established.
Apart from the cochlea the inner ear harbors the vestibular system consisting of the semicircular canals and the two otolithic organs, utriculus and sacculus. The vestibular system is the sensory system that helps us maintain balance. This study aims to investigate if patients with STPHL ie cochlear injury also have impaired vestibular function ie damage to the vestibular system.
The function of the vestibular system can be measured in three main ways. The semicircular canals can be assessed with caloric irrigation and video head impulse test (vHIT). The function of the sacculus and utriculus can be determined by the recording of vestibular evoked myogenic potential (VEMP). The sacculus is assessed by cervical VEMP (cVEMP) and the utriculus by ocular VEMP (oVEMP).
In patients with sensorineural STPHL the damage is most often located in the cochlea in the inner ear. The hypothesis in this study is that these patients also have a deteriorated function in the vestibular system. The aim of this study is to investigate whether the vestibular function between persons with STPHL differ from that of persons with age-adequate hearing levels.
Method: This study will be conducted in the county of Värmland in Sweden, a county with approximately 280,000 inhabitants. Auditbase is the hearing data software used in Värmland where all audiograms are stored. By conducting a database search The investigators have identified all patients in Värmland with severe-to-profound hearing loss.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hearing level of 70 decibel or worse in the better ear
排除标准
- •Congenital deafness
- •Presence of cochlear implant/implants
- •Severe vision impairment
- •Conductive hearing loss
研究组 & 干预措施
Patients with severe-to-profound hearing loss
Patients with severe-to-profound hearing loss will undergo investigation with caloric irrigation, video head impulse test and vestibular evoked myogenic potential. Patients will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: Caloric irrigation (Diagnostic Test)
Patients with severe-to-profound hearing loss
Patients with severe-to-profound hearing loss will undergo investigation with caloric irrigation, video head impulse test and vestibular evoked myogenic potential. Patients will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: vHIT (Diagnostic Test)
Patients with severe-to-profound hearing loss
Patients with severe-to-profound hearing loss will undergo investigation with caloric irrigation, video head impulse test and vestibular evoked myogenic potential. Patients will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: VEMP (Diagnostic Test)
Controls
Controls will undergo investigation with caloric irrigation, video head impuls test and vestibular evoked myogenic potential. Controls will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: Caloric irrigation (Diagnostic Test)
Controls
Controls will undergo investigation with caloric irrigation, video head impuls test and vestibular evoked myogenic potential. Controls will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: vHIT (Diagnostic Test)
Controls
Controls will undergo investigation with caloric irrigation, video head impuls test and vestibular evoked myogenic potential. Controls will complete the Dizziness Handicap Inventory-questionnaire.
干预措施: VEMP (Diagnostic Test)
结局指标
主要结局
Cervical vestibular evoked myogenic potential (cVEMP).
时间窗: Baseline
cVEMP gives information whether the response can be recorded at all. The latency time to the response and the amplitude of the response will be measured. The values of patients with STPHL will be compared with the values from the controls.
Caloric irrigation
时间窗: Baseline
This tests results in two measurements of slow phase velocity of the nystagmus in each ear. A total of four measurements when combining both ears. The values of patients with STPHL will be compared with the values from the controls.
Video head impuls test (vHIT)
时间窗: Baseline
The vHIT gives a gain value of the vestibulo-ocular reflex for each of the semicircular canals. The values of patients with STPHL will be compared with the values from the controls.
Ocular vestibular evoked myogenic potential (oVEMP).
时间窗: Baseline
oVEMP gives information whether the response can be recorded at all. The latency time to the response and the amplitude of the response will be measured. The values of patients with STPHL will be compared with the values from the controls.
次要结局
未报告次要终点