NCT00976547

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

September 11, 2009

Last Update Submit

September 11, 2009

Conditions

TinnitusHearing LossDepression

Keywords

tinnitusdepressionaudiometrymeasurement

Study Arms (1)

Tinnitus patients

Group of 48 tinnitus patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

48 tinnitus patients sensorineural hearing losses

You may qualify if:

  • tinnitus for more than 6 months
  • sensorineural hearing loss
  • normal otoscopy

You may not qualify if:

  • conductive or mixed hearing losses
  • A-r, A-d, B and C tympanograms
  • tinnitus treatment in the last 6 months
  • pregnant woman
  • Vestibular Schwannoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Diagnóstico e Tratamento do Zumbido

Belo Horizonte, Minas Gerais, Brazil

Location

OTOSUL,Otorrinolaringologia Sul-Fluminense

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

Location

MeSH Terms

Conditions

TinnitusHearing LossDepression

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ricardo R Figueiredo, MDMSc

    OTOSUL, Faculdade de Medicina de Valença

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

BR(2)