Clinical trial NCT02951715: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Noise-Induced
Tinnitus, Noise Induced
Zinc Deficiency
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung University
First posted: 2016-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 2 months
measure: Serum zinc level
timeFrame: 2 months
Secondary outcomes:
measure: Pure tone audiometry (PTA)
timeFrame: 2 months
measure: Speech discrimination
timeFrame: 2 months
measure: Distortion product otoacoustic emissions (DPOAE)
timeFrame: 2 months
measure: Pitch of tinnitus
timeFrame: 2 months
measure: Loudness of tinnitus
timeFrame: 2 months
measure: Tinnitus loudness level (dB SL)
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: CHIH-YEN CHIEN, Professor
role: STUDY_DIRECTOR
References: