NCT04892095

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,427

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

May 6, 2021

Last Update Submit

May 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tinnitus prevalence

    Prevalence of study participants reporting having tinnitus

    Baseline

Study Arms (1)

Study participants

Adult subjects (men and women) aged 18 years or more, living in 12 European countries

Other: No intervention

Interventions

This is an observational cross-sectional study. No intervention is considered.

Study participants

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In each of the 12 selected European countries, approximately 1000 individuals, representative of the general population aged 18 years and above in terms of age, sex, geographic area, and socio-economic characteristics, were enrolled in this cross-sectional study. The final sample therefore includes a total of 11,427 subjects.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DOXA Institute

Milan, 20144, Italy

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Silvano Gallus, ScD

    Istituto Di Ricerche Farmacologiche Mario Negri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 19, 2021

Study Start

June 1, 2017

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations