The Akloma Tinnitus Patch in Patients With Manifested Tinnitus (the Aktin Study)
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Akloma Bioscience AB
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
概览
简要总结
OBJECTIVES:
Primary Objective The primary objective will be a decrease of inconvenience with at least 10% for at least 50% of the subjects.
Secondary Objectives
The secondary objective will be to:
To evaluate if the patch can improve the tinnitus patient's quality of life and sleep quality.
METHODOLOGY
Study Design:
An open safety and performance clinical investigation of the antinitus patch in patients with manifested tinnitus.
Treatment Duration:
1 patch per day for 3 weeks
Primary Endpoint:
Tinnitus severity questionnaire (TSQ)
Performance Parameters:
Tinnitus severity questionnaire (TSQ) and numerical rating scale (NRS) measuring tinnitus annoyance.
Quality of life and sleep quality
Safety Parameters: Adverse Reactions
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults of both sexes \> 18 years of age
- •Signed informed consent
- •Patients who have suffered from tinnitus for ≥ 4 weeks before study entry
- •Manifested tinnitus grade II or above on the Klockhoff-Lindblom tinnitus severity grading scale.
- •Tinnitus score of 5 or above (numerical rating scale for tinnitus annoyance)
- •Pure tone averages better than 40 dB in the worse hearing ear.
排除标准
- •Pregnant or lactating women
- •Malignancy or other serious medical conditions
- •Skin disease
- •Simultaneous or previous (within 30 days prior to study entry) participation in a clinical study using experimental drugs or devices.
- •Severe psychiatric disorder
- •Serious suicidal risk
- •Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before study start.
- •Patients with untreated high blood pressure ≥140/90 mmHg
- •Other tinnitus treatment within 6 weeks before study entry.
- •Previous use of the Antinitus patch
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 7 weeks
Tinnitus severity questionnaire score as a measure of efficacy
时间窗: 3 weeks
次要结局
未报告次要终点