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Effects of Caffeine in Tinnitus

Primary Purpose

Tinnitus

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

caffeine

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, caffeine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

tinnitus for more than 6 months
THI > 38
no central acting drugs in the last 6 months
tympanogram type A-n
daily intake of caffeine greater than 150 ml

Exclusion Criteria:

vascular and muscular tinnitus
concomitant TMJ disorders
abnormal otoscopy
mixed and conductive hearing losses
Ménière disease

Sites / Locations

Faculdade de Medicina de Valença
OTOSUL Otorrinolaringologia Sul-Fluminense

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory

Secondary Outcome Measures

Visual Analog Scale

Full Information

NCT ID

NCT00628316

First Posted

February 25, 2008

Last Updated

March 21, 2011

Sponsor

Faculdade de Medicina de Valenca

1. Study Identification

Unique Protocol Identification Number

NCT00628316

Brief Title

Effects of Caffeine in Tinnitus

Official Title

Effects of Caffeine Consumption on Tinnitus Perception

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Faculdade de Medicina de Valenca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Caffeine intake is reported by many authors to enhance the perception of tinnitus. The aim of this study is to determine the effects of 1 month caffeine intake reduction in the scores of validated questionnaire Tinnitus Handicap Inventory (THI) and in a visual-analog scale (VAS).

Detailed Description

A group of 50 patients who takes more than 3 small cups (50 ml) of caffeine daily and have tinnitus will be asked to reduce caffeine intake for 1 month. Scores of THI and VAS will be taken before and after this period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

Keywords

tinnitus, caffeine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Dietary Supplement

Intervention Name(s)

caffeine

Intervention Description

caffeine daily intake will be reduced form 150 ml per day

Primary Outcome Measure Information:

Title

Tinnitus Handicap Inventory

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Visual Analog Scale

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: tinnitus for more than 6 months THI > 38 no central acting drugs in the last 6 months tympanogram type A-n daily intake of caffeine greater than 150 ml Exclusion Criteria: vascular and muscular tinnitus concomitant TMJ disorders abnormal otoscopy mixed and conductive hearing losses Ménière disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ricardo R Figueiredo, MD,MSc

Organizational Affiliation

Faculdade de Medicina de Valença

Official's Role

Study Chair

Facility Information:

Facility Name

Faculdade de Medicina de Valença

City

Valença

State/Province

ZIP/Postal Code

27600-000

Country

Brazil

Facility Name

OTOSUL Otorrinolaringologia Sul-Fluminense

City

Volta Redonda

State/Province

ZIP/Postal Code

27255-650

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Effects of Caffeine in Tinnitus

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