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Improvement of Tinnitus After Oral Zinc on Patients With Noise-induced Hearing Loss

Primary Purpose

Hearing Loss, Noise-Induced, Tinnitus, Noise Induced, Zinc Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zinc gluconate
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Noise-Induced

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 1) bilateral typical NIHL audiogram and type A tympanogram; 2) hearing threshold above 4k Hz was greater than 25 dB HL; 3) audiogram showed the characteristic 4 kHz or 6 kHz notch (average hearing threshold was 10 dB HL higher than the baseline); 4) up-turn phenomenon appeared above 6 kHz or 8 kHz, and 5) symmetrical hearing loss threshold over bilateral ears and the disparity was less than 10 dB HL. Patients with other otologic diseases were excluded.

Exclusion Criteria:

  • Patients with pregnancy, psychologic diseases and other otologic diseases were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Zinc

    Arm Description

    A full medical history assessment was performed, and each patient completed the NIHL questionnaire (Supplementary S1), audiogram, tympanogram, speech discrimination test, distortion product otoacoustic emissions (DPOAE) testing, pitch and loudness match of the tinnitus, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. All tests were repeated after 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day).

    Outcomes

    Primary Outcome Measures

    Tinnitus Handicap Inventory (THI)
    We used the Mandarin-Chinese version of THI questionnaire to evaluate subjective tinnitus19. The severity of subjective tinnitus was divided into five subgroups including very mild (0~16 points), mild (18~36 points), moderate (38~56 points), severe (58~76 points), and very severe (78~100 points).
    Serum zinc level

    Secondary Outcome Measures

    Pure tone audiometry (PTA)
    Tests were conducted in a sound-treated booth (background noise level less than 30 dB A) equipped with a two-channel clinical audiometer (GSI 61).
    Speech discrimination
    Tests were conducted in a sound-treated booth (background noise level less than 30 dB A) equipped with a two-channel clinical audiometer (GSI 61).
    Distortion product otoacoustic emissions (DPOAE)
    The measurement of DPOAE used two pure-tone stimuli at frequencies of 65 dB sound pressure level (SPL) (f1) and 55 dB SPL (f2) with an f2/f1 (frequency) ratio of 1.22. The geometric mean frequencies (GM Hz) ranged from 5 to 10 kHz. The most robust DPOAE occurs at the frequency determined by the equation 2f1-f2 (recorded as DP Hz), whereas the actual cochlear frequency region assessed with DPOAE is between these two frequencies, probably close to the f2 stimulus. The stimulus intensity was defined as positive when all frequencies of 2f1-f2 tested 6 dB SPL greater than the noise floors (NF).
    Pitch of tinnitus
    When the matching procedure was first used, the level was initially set at 5 dB above the highest measured audiometric threshold (at any frequency), and the patient reported the audiometric frequency that gave the closest match to the pitch of their tinnitus, repeated three times.
    Loudness of tinnitus
    Then the level was adjusted in 2-dB steps until the patient indicated that the tone matched the loudness of their tinnitus, repeated three times.
    Tinnitus loudness level (dB SL)
    The tinnitus loudness level (dB SL) was calculated as the intensity level minus the baseline-hearing threshold

    Full Information

    First Posted
    October 31, 2016
    Last Updated
    October 31, 2016
    Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    Chang Gung University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02951715
    Brief Title
    Improvement of Tinnitus After Oral Zinc on Patients With Noise-induced Hearing Loss
    Official Title
    Evaluation of the Effects of Zinc in the Management on Tinnitus Patients With Noise Induced Hearing Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital
    Collaborators
    Chang Gung University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Twenty patients with tinnitus and a typical noise-induced hearing loss (NIHL) audiogram were included. Each subject underwent an otoscopic examination, distortion product otoacoustic emissions, tinnitus-match testing, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. After 2 months of treatment with zinc, all tests were repeated.
    Detailed Description
    This study enrolled patients who visited our out-patient department with the primary complaint of tinnitus. A full medical history assessment was performed, and each patient underwent an otoscopic examination, a basic audiologic evaluation. We selected the patients whose audiogram data met the inclusion criteria for NIHL: 1) bilateral typical NIHL audiogram and type A tympanogram; 2) hearing threshold above 4 kilohertz (kHz) was greater than 25 dB hearing level (HL); 3) audiogram showed the characteristic 4 kHz or 6 kHz notch (average hearing threshold was 10 dB HL higher than the baseline); 4) up-turn phenomenon appeared above 6 kHz or 8 kHz, and 5) symmetrical hearing loss threshold over bilateral ears and the disparity was less than 10 dB HL. Patients with other otologic diseases were excluded. A full medical history assessment was performed, and each patient completed the NIHL questionnaire (Supplementary S1), audiogram, tympanogram, speech discrimination test, distortion product otoacoustic emissions (DPOAE) testing, pitch and loudness match of the tinnitus, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. All tests were repeated after 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Noise-Induced, Tinnitus, Noise Induced, Zinc Deficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zinc
    Arm Type
    Experimental
    Arm Description
    A full medical history assessment was performed, and each patient completed the NIHL questionnaire (Supplementary S1), audiogram, tympanogram, speech discrimination test, distortion product otoacoustic emissions (DPOAE) testing, pitch and loudness match of the tinnitus, Tinnitus Handicap Inventory (THI) and serum zinc level analyses. All tests were repeated after 2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day).
    Intervention Type
    Drug
    Intervention Name(s)
    zinc gluconate
    Other Intervention Name(s)
    Zinga
    Intervention Description
    2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day)
    Primary Outcome Measure Information:
    Title
    Tinnitus Handicap Inventory (THI)
    Description
    We used the Mandarin-Chinese version of THI questionnaire to evaluate subjective tinnitus19. The severity of subjective tinnitus was divided into five subgroups including very mild (0~16 points), mild (18~36 points), moderate (38~56 points), severe (58~76 points), and very severe (78~100 points).
    Time Frame
    2 months
    Title
    Serum zinc level
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Pure tone audiometry (PTA)
    Description
    Tests were conducted in a sound-treated booth (background noise level less than 30 dB A) equipped with a two-channel clinical audiometer (GSI 61).
    Time Frame
    2 months
    Title
    Speech discrimination
    Description
    Tests were conducted in a sound-treated booth (background noise level less than 30 dB A) equipped with a two-channel clinical audiometer (GSI 61).
    Time Frame
    2 months
    Title
    Distortion product otoacoustic emissions (DPOAE)
    Description
    The measurement of DPOAE used two pure-tone stimuli at frequencies of 65 dB sound pressure level (SPL) (f1) and 55 dB SPL (f2) with an f2/f1 (frequency) ratio of 1.22. The geometric mean frequencies (GM Hz) ranged from 5 to 10 kHz. The most robust DPOAE occurs at the frequency determined by the equation 2f1-f2 (recorded as DP Hz), whereas the actual cochlear frequency region assessed with DPOAE is between these two frequencies, probably close to the f2 stimulus. The stimulus intensity was defined as positive when all frequencies of 2f1-f2 tested 6 dB SPL greater than the noise floors (NF).
    Time Frame
    2 months
    Title
    Pitch of tinnitus
    Description
    When the matching procedure was first used, the level was initially set at 5 dB above the highest measured audiometric threshold (at any frequency), and the patient reported the audiometric frequency that gave the closest match to the pitch of their tinnitus, repeated three times.
    Time Frame
    2 months
    Title
    Loudness of tinnitus
    Description
    Then the level was adjusted in 2-dB steps until the patient indicated that the tone matched the loudness of their tinnitus, repeated three times.
    Time Frame
    2 months
    Title
    Tinnitus loudness level (dB SL)
    Description
    The tinnitus loudness level (dB SL) was calculated as the intensity level minus the baseline-hearing threshold
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1) bilateral typical NIHL audiogram and type A tympanogram; 2) hearing threshold above 4k Hz was greater than 25 dB HL; 3) audiogram showed the characteristic 4 kHz or 6 kHz notch (average hearing threshold was 10 dB HL higher than the baseline); 4) up-turn phenomenon appeared above 6 kHz or 8 kHz, and 5) symmetrical hearing loss threshold over bilateral ears and the disparity was less than 10 dB HL. Patients with other otologic diseases were excluded. Exclusion Criteria: Patients with pregnancy, psychologic diseases and other otologic diseases were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    CHIH-YEN CHIEN, Professor
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Improvement of Tinnitus After Oral Zinc on Patients With Noise-induced Hearing Loss

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