The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- hearing threshold
研究概览
简要总结
This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged >= 18 and <= 70,
- •diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI > 15/h,
- •diagnosed with ISSHL by AAO-HNS 2019 criteria,
- •ISSHL onset within 1 week.
排除标准
- •sudden hearing loss with certain causes,
- •with severe comorbid diseases,
- •pregnant or breast-feeding women,
- •AHI <= 15/h,
- •hearing threshold recovered > 50% when included,
- •previously regularly treated with PAP.
研究组 & 干预措施
medication
patients treated by medication only
干预措施: Ginaton (Drug)
PAP plus medication
patients treated by both PAP and medication
干预措施: non-invasive positive airway pressure (Device)
PAP plus medication
patients treated by both PAP and medication
干预措施: Methylprednisolone Hemisuccinate (Drug)
PAP plus medication
patients treated by both PAP and medication
干预措施: Ginaton (Drug)
medication
patients treated by medication only
干预措施: Methylprednisolone Hemisuccinate (Drug)
结局指标
主要结局
hearing threshold
时间窗: 3 months after onset of ISSHL
the recovery of hearing threshold which will be measured by pure tone audiometry
次要结局
未报告次要终点
研究者
Ye Jingying
Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine
Beijing Tsinghua Chang Gung Hospital