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The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial

Primary Purpose

Tinnitus, Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sound generator
hearing aids with only amplification
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring tinnitus, hearing loss, hearing devices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • mild to moderate sensorineural hearing loss
  • tinnitus (THI > 20)
  • first user

Exclusion Criteria:

  • profound hearing loss
  • conductive hearing loss
  • THI < 20

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    control

    sound generator

    Arm Description

    hearing aid without an integrated sound generator

    hearing aid with an integrated sound generator

    Outcomes

    Primary Outcome Measures

    THI
    tinnitus handicap inventory

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2013
    Last Updated
    June 25, 2013
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01857661
    Brief Title
    The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
    Official Title
    The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This study, in the form of a blind randomized clinical trial, was approved by CAPPesq under protocol number: 0163/10. 49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. Both groups received counseling about tinnitus. One group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. After the fitting process, both groups were told to use the hearing devices 8 hours per day. The outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus, Hearing Loss
    Keywords
    tinnitus, hearing loss, hearing devices

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Other
    Arm Description
    hearing aid without an integrated sound generator
    Arm Title
    sound generator
    Arm Type
    Experimental
    Arm Description
    hearing aid with an integrated sound generator
    Intervention Type
    Device
    Intervention Name(s)
    sound generator
    Intervention Description
    hearing aid with an integrated sound generator
    Intervention Type
    Device
    Intervention Name(s)
    hearing aids with only amplification
    Primary Outcome Measure Information:
    Title
    THI
    Description
    tinnitus handicap inventory
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: mild to moderate sensorineural hearing loss tinnitus (THI > 20) first user Exclusion Criteria: profound hearing loss conductive hearing loss THI < 20

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25073131
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial

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