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临床试验/NCT04892095
NCT04892095已完成不适用

The European Tinnitus Survey: a Cross-sectional Observational Study on Tinnitus Prevalence in 12 European Countries

Mario Negri Institute for Pharmacological Research1 个研究点 分布在 1 个国家目标入组 11,427 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11,427
试验地点
1
主要终点
Tinnitus prevalence

研究概览

简要总结

A European cross-sectional study was conducted with the aims of: i) examining inter-country differences in prevalence of tinnitus by comparing prevalence estimates in countries with relatively low versus high gross domestic product (GDP) per capita and comparing prevalence estimates in countries within different European regions (i.e., Northern, Southern, Eastern and Western Europe); ii) understanding the effect of sex, age, socio-economic variables, body mass index (BMI), and marital status on overall prevalence of tinnitus; iii) assessing the effect of hearing difficulty on tinnitus prevalence; and iv) exploring the effect of tinnitus severity on use of healthcare resource for tinnitus Overall, approximately 12,000 individuals aged 18 years or over are enrolled in 12 different European countries (BG, DE, ES, FR, GR, IE, IT, LV, PL, PT, RO, UK). Survey sample from each country were representative of the country-specific population in terms of sex, age, and socio-economic characteristics.

详细描述

BACKGROUND AND RATIONALE Tinnitus is a common symptom of clinically heterogeneous pathologies and is defined as the conscious perception of an auditory sensation in the absence of a corresponding external stimulus. Tinnitus, in its debilitating form, negatively affects emotional health and social well-being, and can precipitate psychological distress severe enough to cause self-harm and suicidal ideations, while exerting substantial individual and societal financial burden. Therefore, it becomes crucial to implement adequate preventive measures and health interventions. According to population-based studies from Western Europe and US, tinnitus prevalence lies between 10% and 15%. Nonetheless, there is a lack of clear understanding of global prevalence of tinnitus. Inherent methodological drawbacks and between study differences hinder deriving a global estimate by pooling data from studies conducted in different countries and world regions. Therefore, uncertainties with regards to the prevalence of tinnitus remain.

OBJECTIVE The primary objective of this population-based cross-sectional study is to estimate the overall and country specific prevalence of any tinnitus, bothersome tinnitus, and severe tinnitus in 12 European Union (EU) countries.

The study data have been analyzed to fulfil the following secondary objectives:

  • To examine inter-country differences in prevalence of tinnitus by making the following comparisons:

  • Comparing prevalence estimates in countries with relatively low versus high gross domestic product (GDP) per capita

  • Comparing prevalence estimates in countries within different European regions (i.e., Northern, Southern, Eastern and Western Europe)

  • To understand the effect of sex, age, socio-economic variables, body mass index (BMI), and marital status on overall prevalence of tinnitus

  • To assess the effect of hearing difficulty on tinnitus prevalence

  • To explore the effect of tinnitus severity on use of healthcare resource for tinnitus

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • individuals aged 18 years and above
  • individuals who are residents of the 12 selected countries
  • individuals able to understand and answer the questions of the study questionnaire in the country-specific language
  • individuals who formally accept to participate in the study

排除标准

  • No specific exclusion criteria are considered

结局指标

主要结局

Tinnitus prevalence

时间窗: Baseline

Prevalence of study participants reporting having tinnitus

次要结局

未报告次要终点

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (1)

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