TinnitusNCT00628316
Effects of Caffeine in Tinnitus
A study testing caffeine in people with Tinnitus, run by Faculdade de Medicina de Valenca at 2 sites in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- caffeine
- How many people
- 50 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
- Ménière disease
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Faculdade de Medicina de Valença
Valença, Rio de Janeiro, 27600-000
OTOSUL Otorrinolaringologia Sul-Fluminense
Volta Redonda, Rio de Janeiro, 27255-650
About this study
Official title: Effects of Caffeine Consumption on Tinnitus Perception
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).
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineDietary supplement
caffeine daily intake will be reduced form 150 ml per day
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory
Measured: 30 days
Secondary outcomes (1)
Visual Analog Scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Valenca
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo R Figueiredo, MD,MSc, Study chair, Faculdade de Medicina de Valença
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628316
- Sponsor's protocol ID
- FMV 001 2008
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caffeine Consumption on Tinnitus Perception
- ClinicalTrials.gov ID
- NCT00628316
- Acronym / sponsor ID
- FMV 001 2008
- Conditions
- Tinnitus
- Keywords
- tinnitus, caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Faculdade de Medicina de ValencaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
- Ménière disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeinecaffeine daily intake will be reduced form 150 ml per day | Dietary supplement | – |
Primary outcome
Tinnitus Handicap Inventory
Time frame: 30 days
1 secondary outcome
Visual Analog Scale
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo R Figueiredo, MD,MSc study chair
Faculdade de Medicina de Valença
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine in people with Tinnitus, run by Faculdade de Medicina de Valenca at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011.