TinnitusNCT00976547
Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients
An observational study of Tinnitus and Hearing Loss, run by Faculdade de Medicina de Valenca at 2 sites in Brazil.
Trial summary
Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus, Hearing Loss, Depression
- How many people
- 48 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2009to Jun 2009
- Phase
- Observational
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: 48 tinnitus patients sensorineural hearing losses
Who may be able to join
- tinnitus for more than 6 months
- sensorineural hearing loss
- normal otoscopy
Who cannot join
- conductive or mixed hearing losses
- A-r, A-d, B and C tympanograms
- tinnitus treatment in the last 6 months
- pregnant woman
- Vestibular Schwannoma
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Diagnóstico e Tratamento do Zumbido
Belo Horizonte, Minas Gerais
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, Rio de Janeiro, 27255-650
About this study
Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients.
Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil.
Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.
- Conditions
- Tinnitus, Hearing Loss, Depression
- Keywords
- tinnitus, depression, audiometry, measurement
- Medical subject headings
- Tinnitus, Hearing Loss, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tinnitus patients | Group of 48 tinnitus patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionJun 2009
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Valenca
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo R Figueiredo, MDMSc, Study chair, OTOSUL, Faculdade de Medicina de Valença
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976547
- Sponsor's protocol ID
- FMV 2009 001
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of Hearing Thresholds, Validated Questionnaires and Psychoacoustic Measurements in Tinnitus Patients
- ClinicalTrials.gov ID
- NCT00976547
- Acronym / sponsor ID
- FMV 2009 001
- Conditions
- Tinnitus, Hearing Loss, Depression
- Keywords
- tinnitus, depression, audiometry, measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Faculdade de Medicina de ValencaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Sep 2009 (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.
Objective: To evaluate the correlation between audiometric thresholds, pitch matching (PM), minimum masking level (MML), Tinnitus Handicap Inventory (THI) and the Beck Depression Inventory (BDI) in tinnitus patients.
Subjects: 48 patients with tinnitus as the main complaint from OTOSUL, Otorrinolaringologia Sul-Fluminense, Volta Redonda, RJ, Brasil and Centro de Tratamento e Pesquisa em Zumbido, Belo Horizonte, MG, Brasil.
Method: Subjects performed tonal audiometry, Pitch Matching (PM) and Minimum Masking Level (MML) for tinnitus. They also fulfilled the Tinnitus Handicap Inventory (THI) and Beck Depression Inventory (BDI). Data was statistically compared for correlation between audiometric thresholds, psycho-acoustic measures and questionnaires.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tinnitus patients | – | –Group of 48 tinnitus patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 48 tinnitus patients sensorineural hearing losses
Key inclusion criteria (3 listed)
- tinnitus for more than 6 months
- sensorineural hearing loss
- normal otoscopy
Key exclusion criteria (5 listed)
- conductive or mixed hearing losses
- A-r, A-d, B and C tympanograms
- tinnitus treatment in the last 6 months
- pregnant woman
- Vestibular Schwannoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Sep 2009.
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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, MDMSc study chair
OTOSUL, 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?
An observational study of Tinnitus and Hearing Loss, 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 3 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 14 Sep 2009. 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.
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 14 Sep 2009.