The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
1 other identifier
interventional
49
0 countries
N/A
Brief Summary
The University of Sao Paulo Department of Otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. These prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population). Currently, the Brazilian Public Heath Care does not have any such hearing aids. So, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of Public Policies in Brazil. The aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Shorter than P25 for not_applicable
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
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 15, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedJune 26, 2013
May 1, 2013
7 months
May 15, 2013
June 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
THI
tinnitus handicap inventory
3 months
Study Arms (2)
control
OTHERhearing aid without an integrated sound generator
sound generator
EXPERIMENTALhearing aid with an integrated sound generator
Interventions
Eligibility Criteria
You may qualify if:
- mild to moderate sensorineural hearing loss
- tinnitus (THI \> 20)
- first user
You may not qualify if:
- profound hearing loss
- conductive hearing loss
- THI \< 20
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
dos Santos GM, Bento RF, de Medeiros IR, Oiticcica J, da Silva EC, Penteado S. The influence of sound generator associated with conventional amplification for tinnitus control: randomized blind clinical trial. Trends Hear. 2014 Jul 23;18:2331216514542657. doi: 10.1177/2331216514542657.
PMID: 25073131DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 15, 2013
First Posted
May 20, 2013
Study Start
September 1, 2012
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
June 26, 2013
Record last verified: 2013-05