Prognostic Factors for Outcomes of Idiopathic Sudden Onset Sensorineural Hearing Loss
试验速览
- 阶段
- 不适用
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Change in auditory function
研究概览
简要总结
Each year, approximately 15,000 people in the United Kingdom experience sudden loss of hearing that is sensorineural in nature. In the majority of cases, the cause is unknown despite investigation, and these cases are termed idiopathic 'sudden onset sensorineural hearing loss' (SSNHL). Treatment options for idiopathic SSNHL mainly include steroid treatments, with considerable limitations in their effectiveness and evidence base.
There are a number of new treatments being developed for idiopathic SSNHL based upon recent discoveries in underlying molecular mechanisms. These treatments require rigorous testing in clinical trials before they can become available for clinical use. To allow for such trials to be run effectively, there is an urgent need for information on patient numbers, geographical distribution, demographics, patient and treatment pathways, as well as outcomes.
This study proposes to collect these data through an ENT trainee and Audiologist led nationwide prospective cohort study of adult patients presenting with SSNHL within the National Health Services (NHS). The study will take place at 97 NHS sites across England with Ear, Nose, and Throat (ENT) and Audiology services.
Data once collected will be analysed to:
- Establish the patient pathway for patients presenting with SSNHL in the NHS
- Develop a tool that will help predict recovery for patients with idiopathic SSNHL.
- Establish the impact of idiopathic SSNHL on people's quality of life.
详细描述
Each year, approximately 20 people per 100,000 experience sudden loss of hearing that is sensorineural in nature. 'Sensorineural' indicates an abnormality of the cochlea, the auditory nerve, or higher central auditory pathways. When the hearing loss is of 30 dB (decibel) or more, over at least 3 contiguous frequencies and within 3 days, the condition is termed sudden onset sensorineural hearing loss (SSNHL). SSNHL is predominantly unilateral and the hearing loss can range from mild to profound. In 71% to 90% of cases, the cause is unknown despite investigation, and these cases are termed idiopathic.
Associated symptoms include tinnitus, vertigo and aural fullness. Idiopathic SSNHL is a serious condition, adversely impacting people's lives with research indicating associations with emotional distress, depression, difficulties at work and impaired social integration. It is estimated that 32% to 65% of cases of idiopathic SSNHL recover spontaneously, although clinical experience suggests that this may be an overestimation, with further research required in this area.
Current care pathways for patients suffering from idiopathic SSNHL appear to vary considerably in terms of the type of service patients first present to, their subsequent referral, length of time between onset of symptoms, presentation and start of treatment, the treatment plan as well as follow-up. Treatment options for idiopathic SSNHL include systemic and intratympanic steroids, antiviral agents, rheological agents, diuretics, hyperbaric oxygen treatment, and observation alone. The lack of evidence regarding the comparative effectiveness of these treatments is recognised by clinical guidelines published by National Institute for Health and Care Excellence (NICE), the American Academy of Otolaryngology-Head and Neck Surgery (ORL-HNS), and the British Academy of Audiology.
Based upon recent discoveries in the molecular mechanisms that lead to sensorineural hearing loss, biotechnology and pharmaceutical companies are developing new treatments for patients with idiopathic SSNHL. These treatments require rigorous testing in clinical trials before they can become available for application in a clinical service setting. To allow for such trials to be run effectively reliable information is required on where patients with idiopathic SSNHL present and can be recruited from within the optimum timeframe from onset of symptoms to start of treatment based upon the preclinical profile of the drug. This means that there is an urgent need for information on patient numbers, geographical distribution, demographics, patient and treatment pathways, as well as outcomes.
This study proposes to collect these data through an ENT trainee and Audiologist led nationwide prospective cohort study of adult patients presenting with SSNHL within the NHS. Importantly, this study will not only provide key data to inform future trial design and delivery, but also a unique dataset to develop a prediction model to predict recovery for patients with idiopathic SSNHL.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (male or female) aged over 16 years of age presenting to NHS ENT and hearing services with SSNHL AND
- •Diagnosed with a hearing loss in one or both ears of 30 dB HL or more, over at least 3 contiguous frequencies, between 250, 500, 1000, 2000, 4000 and 8000 Hz.
- •Willing and able to provide written informed consent.
排除标准
- •Patients with mixed or conductive hearing loss (CHL). CHL will be defined as a 'true' air-bone gap of 15 dB HL or more in 3 or more contiguous frequencies between 500, 1000, 2000, 4000 Hz.
结局指标
主要结局
Change in auditory function
时间窗: 6 to 16 weeks from onset of symptoms
The change in auditory function in the affected ear from initial presentation to follow-up (at any one time between 6 and 16 weeks from onset of symptoms). Auditory function will be defined as the Pure Tone Average (PTA) of air conduction thresholds at 250, 500, 1000, 2000, 4000 and 8000 Hz. If multiple pure tone audiograms have been carried out between 6 and 16 weeks, the most recent pure tone audiogram will be used for the calculation of auditory function. Change in auditory function classified as: 1. Full recovery: Final PTA in affected ear within 10dB of PTA of unaffected ear (≤10dB) 2. Partial to no recovery: Final PTA in affected ear ≥ 10dB of PTA of unaffected ear.
次要结局
- Degree of change in auditory function(6 to 16 weeks from onset of symptoms)
- Quality of life using Health Utility Index 3(6 to 16 weeks from onset of symptoms)
- Quality of life using Hearing Handicap Inventory(6 to 16 weeks from onset of symptoms)