Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Tinnitus impact
研究概览
简要总结
Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus.
Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors after implantation.
详细描述
Primary objective:
Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss.
Secondary objectives:
- Determine the prevalence, nature, and severity of tinnitus before cochlear implantation.
- Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation.
- Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus.
Patient identification:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older.
- •Determined to be eligible for unilateral cochlear implantation.
- •Did not previously receive a cochlear implant in either ear.
- •Sufficient written or spoken English to participate in study activities.
- •Have access to internet or suitable device to complete online study questionnaires.
- •Able to give informed consent.
排除标准
- •Significant difficulties preventing independent completion of study activities.
结局指标
主要结局
Tinnitus impact
时间窗: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Tinnitus Functional Index (TFI). Maximum score: 250, higher score indicates greater tinnitus symptom severity
Tinnitus characteristics and associated medical and sociodemographic factors
时间窗: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ). This is a case history questionnaire without a numerical scoring system.
Anxiety
时间窗: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety
Patient health
时间窗: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms
Insomnia
时间窗: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
Insomnia Severity Index (ISI) scored 0 to 28 with a higher score indicating more severe insomnia
Life quality
时间窗: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
EuroQol Quality of Life Questionnaire (EQ-5D-5L) scored from 0 to 100, with a lower score indicating worse health
Hearing function
时间窗: Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant
Speech, Spatial and Qualities of Hearing (SSQ-12) questionnaire scored 0-120, with a higher score indicating better hearing ability
次要结局
未报告次要终点
研究者
Derek Hoare
Chief Investigator
University of Nottingham