NCT00628316

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

2 active sites

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

January 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 22, 2011

Status Verified

February 1, 2008

Enrollment Period

8 months

First QC Date

February 25, 2008

Last Update Submit

March 21, 2011

Conditions

Tinnitus

Keywords

tinnituscaffeine

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Handicap Inventory

    30 days

Secondary Outcomes (1)

  • Visual Analog Scale

    30 days

Interventions

caffeineDIETARY_SUPPLEMENT

caffeine daily intake will be reduced form 150 ml per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculdade de Medicina de Valença

Valença, Rio de Janeiro, 27600-000, Brazil

Location

OTOSUL Otorrinolaringologia Sul-Fluminense

Volta Redonda, Rio de Janeiro, 27255-650, Brazil

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Caffeine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ricardo R Figueiredo, MD,MSc

    Faculdade de Medicina de Valença

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

March 22, 2011

Record last verified: 2008-02

Locations

BR(2)