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
About this trial
This is an interventional treatment trial for Hearing Loss, Noise-Induced
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.
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
NCT ID
NCT02951715
First Posted
October 31, 2016
Last Updated
October 31, 2016
Sponsor
Chang Gung Memorial Hospital
Collaborators
Chang Gung University
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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