Prognosis of Vestibular Dysfunction in Patients With Idiopathic Sudden Sensorineural Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
研究概览
简要总结
Idiopathic sudden sensorineural hearing loss (ISSNHL) refers to idiopathic sensorineural hearing loss of at least 30 dB over at least three test frequencies occurring over a 72-hour period. Vertigo has been considered a risk factor of poor prognosis in patients with ISSNHL. However, the clinical outcome and development of vestibular function in these patients have not been reported yet. We'd like to conduct a study on the problem whether these patients resulted in a complete recovery of the peripheral vestibular functions or compensation of the central vestibular system. If the answer is the former one, these cases might be supportive evidence of regeneration of hair cells in vestibular disorders.
详细描述
This study is designed as a prospective cohort study with only one cohort. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The primary measurement is the vestibular function tests including SOT, the caloric reflex test, vHIT, VEMP (cVEMP and oVEMP). The secondary measurements included PTA, DHI, and VAS. The sample size was set at 60 patients. The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description. P <0.05 was considered statistically significant.
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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16 to 70 years old.
- •Diagnosed as ISSNHL.
- •Present with vertigo.
- •At least 1 abnormal result in vestibular function tests(SOT, vHIT, caloric reflex test, and VEMP).
- •The onset of the disease was within 30 days.
排除标准
- •Unwilling to sign informed consent.
- •The cause of sudden hearing loss has been identified, such as trauma, vasogenic disease, et al.
- •Bilateral hearing loss.
- •Patients with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss et al.
- •Patients not suitable to receiving vestibular function tests, such as those with severe cervical spine disease, cardiovascular disease, or pregnancy et al.
- •Cognitive impairment;
- •Other conditions that the investigator evaluated the patients as not appropriate for this study.
结局指标
主要结局
Abnormal rate of vestibular function in the Sensory Organization Test(SOT) at baseline.
时间窗: Baseline
abnormal rate=(number of participants who have abnormal results in vestibular function in SOT at the baseline)/(number of participants in total)
Recovery rate of vestibular input in the Sensory Organization Test(SOT) at 2-months follow-up after onset.
时间窗: 2 months after onset
recovery rate=(number of participants who had abnormal results in vestibular function in SOT at the baseline and get normal vestibular function results in SOT at 2-months follow-up after onset)/(number of participants who had abnormal vestibular function results in SOT at the baseline)
Abnormal rate of the caloric test at baseline.
时间窗: Baseline
Abnormal rate=(number of participants who have abnormal results in the caloric test at the baseline)/(number of participants in total). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Recovery rate of the caloric test at 2-months follow-up after onset.
时间窗: 2 months after onset
recovery rate=(number of participants who had abnormal results in the caloric test at the baseline and get normal results in the caloric test at 2-months follow-up after onset)/(number of participants who get abnormal results in the caloric test at the baseline). An abnormal result is considered if unilateral reaction weakening is greater than 22%, and/or directional preponderance is greater than 27%.
Abnormal rate of the vHIT at baseline.
时间窗: Baseline
Abnormal rate=(number of participants who have abnormal results in vHIT at the baseline)/(number of participants in total). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Abnormal rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at baseline.
时间窗: Baseline
Abnormal rate=(number of participants who had abnormal results in oVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Recovery rate of the vHIT at 2-months follow-up after onset.
时间窗: 2 months after onset
recovery rate=(number of the participants who had abnormal results in vHIT at the baseline and get normal results in vHIT at 2-months follow-up after onset)/(number of the participants who get abnormal results in vHIT at the baseline). An abnormal result is considered if there are pathological saccades and the gain of each semicircular canal is out of normal range.
Abnormal rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at baseline.
时间窗: Baseline
Abnormal rate=(number of participants who have abnormal results in cVEMP at the baseline)/(number of participants in total) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Recovery rate of Cervical Vestibular Evoked Myogenic Potentials (cVEMP) at 2-months follow-up after onset.
时间窗: 2 months after onset
recovery rate=(number of the participants who had abnormal results in cVEMP at the baseline and get normal results in cVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in cVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
Recovery rate of Ocular Vestibular Evoked Myogenic Potentials (oVEMP) at 2-months follow-up after onset.
时间窗: 2 months after onset
recovery rate=(number of the participants who had abnormal results in oVEMP at the baseline and get normal results in oVEMP at 2-months follow-up after onset)/(number of the participants who had abnormal results in oVEMP at the baseline) The abnormal result is considered if potentials were not elicited or out of normal range, or the asymmetrical ratio is larger than normal.
次要结局
- Change of Visual Analogue Scale in Vertigo at 2 month after onset(2 months after onset)
- Change of Dizziness Handicap Inventory at 2 months after onset(2 months after onset)
- Change of Pure Tone Audiometry(PTA) at 2 months after onset(2 months after onset)