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

Zinc Deficiency Clinical Trial

Official title:

Evaluation of the Effects of Zinc in the Management on Tinnitus Patients With Noise Induced Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951715
• Other study ID #: 102-3893A3
• Status: Completed
• Phase: N/A
• First received: October 31, 2016
• Last updated: October 31, 2016
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Chang Gung University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 months	No
Primary	Serum zinc level		2 months	No
Secondary	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).	2 months	No
Secondary	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).	2 months	No
Secondary	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).	2 months	No
Secondary	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.	2 months	No
Secondary	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.	2 months	No
Secondary	Tinnitus loudness level (dB SL)	The tinnitus loudness level (dB SL) was calculated as the intensity level minus the baseline-hearing threshold	2 months	No