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

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ClinicalTrials.gov Identifier: NCT02951715
Recruitment Status : Completed
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborator:
Chang Gung University
Information provided by (Responsible Party):
Chung Feng Hwang, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Noise-Induced Tinnitus, Noise Induced Zinc Deficiency Drug: zinc gluconate Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Zinc in the Management on Tinnitus Patients With Noise Induced Hearing Loss
Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Zinc
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).
Drug: zinc gluconate
2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day)
Other Name: Zinga




Primary Outcome Measures :
  1. Tinnitus Handicap Inventory (THI) [ Time Frame: 2 months ]
    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).

  2. Serum zinc level [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Pure tone audiometry (PTA) [ Time Frame: 2 months ]
    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).

  2. Speech discrimination [ Time Frame: 2 months ]
    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).

  3. Distortion product otoacoustic emissions (DPOAE) [ Time Frame: 2 months ]
    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).

  4. Pitch of tinnitus [ Time Frame: 2 months ]
    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.

  5. Loudness of tinnitus [ Time Frame: 2 months ]
    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.

  6. Tinnitus loudness level (dB SL) [ Time Frame: 2 months ]
    The tinnitus loudness level (dB SL) was calculated as the intensity level minus the baseline-hearing threshold



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951715


Sponsors and Collaborators
Chang Gung Memorial Hospital
Chang Gung University
Investigators
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Study Director: CHIH-YEN CHIEN, Professor Chang Gung Memorial Hospital

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Responsible Party: Chung Feng Hwang, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02951715     History of Changes
Other Study ID Numbers: 102-3893A3
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Tinnitus
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs