Effects of Caffeine in Tinnitus

Tinnitus Clinical Trial

Official title:

Effects of Caffeine Consumption on Tinnitus Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628316
• Other study ID #: FMV 001 2008
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: March 21, 2011
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2008
• Source: Faculdade de Medicina de Valenca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Dietary Supplement:
• caffeine
caffeine daily intake will be reduced form 150 ml per day

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina de Valença	Valença	RJ
Brazil	OTOSUL Otorrinolaringologia Sul-Fluminense	Volta Redonda	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina de Valenca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory		30 days	No
Secondary	Visual Analog Scale		30 days	No

External Links

•   Tinnitus Center Homepage