2024-510798-84-00招募中3 期
Hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss - a multicentre randomized controlled trial
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 490
- 试验地点
- 12
- 主要终点
- Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz
研究概览
简要总结
To assess if the addition of HBOT to standard care leads to better hearing 3 months after treatment than treatment with standard care only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Study period
- 盲法
- Single (Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Onset of acute hearing loss no longer than 7 days ago
- •HBO can be started within 7 days from symptom onset
- •Pure tone audiometry shows sensorineural hearing loss with at least 30dB loss in three consecutive frequencies
- •Idiopathic sensorineural hearing loss is the most probable diagnosis according to clinical judgement
- •The hearing threshold is 50 dB or more in PTA (based on 0,5kHz, 1kHz, 2kHz, 4kHz)
排除标准
- •Not idiopathic sudden sensorineural hearing loss, but another disease, injury or condition is most likely the cause of the current hearing loss.
- •Cognitive or language barriers that hamper adherence to the study protocol
- •Major alcohol abuse
- •Any contraindication to treatment with hyperbaric oxygen: - COPD, asthma or other lung disease with severely reduced lung function corresponding to GOLD III (spirometry shows FEV1 <50% of expected) - Asthma not well regulated on oral basic medication and/or with attacks within the last year - Current pneumonia or <4 weeks from complete recovery - X-ray showing emphysema-bulla or non-static atelectasis - Severe cardiac failure, instable angina, cardial infarction <6 months ago - Ongoing use of Disulfiram (Antabus ®) - Earlier treatment with Bleomycin (any time) - Artificial middle ear bones - Pregnancy
结局指标
主要结局
Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz
Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz
次要结局
- Mean change in PTA (dB) from baseline to week 14
- Proportion of patients with improvement of at least 10dB PTA from baseline to week 14
- Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline
- Categories of hearing recovery according to Siegel's criteria at week 14
- Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14
- Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14
- RAND-12 scores at day 1 and week 14
- Adverse events (AE) and serious AEs (SAE)
- Known side-effects of HBOT
- Mean APHAB score at week 14
研究者
Bernd Mueller
Scientific
Helse Bergen HF
研究点 (12)
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