NCT02508220已完成不适用
Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
Berthold Langguth, MD, Ph.D.0 个研究点目标入组 15 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Change of Clinical global impression scale
研究概览
简要总结
The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •chronic tinnitus with a duration > 6 months
- •medical examination by an ENT specialist
- •sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires
- •VAS score >4 points
排除标准
- •vascular tinnitus
- •muscular tinnitus
- •conductive hearing loss
- •previous experience with oxytocin nasal spray
- •additional medications during the intervention
研究组 & 干预措施
Oxy-Placebo
Other
Syntocinon first, Placebo second 2 puffs in each nostril
干预措施: Syntocinon (Drug)
Oxy-Placebo
Other
Syntocinon first, Placebo second 2 puffs in each nostril
干预措施: Placebo (Drug)
Placebo-Oxy
Other
Placebo first, Syntocinon second 2 puffs in each nostril
干预措施: Syntocinon (Drug)
Placebo-Oxy
Other
Placebo first, Syntocinon second 2 puffs in each nostril
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Clinical global impression scale
时间窗: 30 minutes after intervention
Change of tinnitus on VAS
时间窗: 30 minutes after intervention
次要结局
- Tinnitus Matching(within one hour before intervention)
- Minimum Masking Level measured in dB HL(within one hour before intervention)
- Audiometry measured in dB HL(within one hour before intervention)
研究者
Berthold Langguth, MD, Ph.D.
Chair of the Tinnitus centrum Regensburg
University of Regensburg
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