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

NCT02951715 | Completed DMC

• 1 other identifier: 102-3893A3
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• Serum zinc level

  2 months

Secondary Outcomes (6)

• Pure tone audiometry (PTA)

  2 months

• Speech discrimination

  2 months

• Distortion product otoacoustic emissions (DPOAE)

  2 months

• Pitch of tinnitus

  2 months

• Loudness of tinnitus

  2 months

Study Arms (1)

Zinc

EXPERIMENTAL

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

Interventions

zinc gluconate DRUG

2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day)

Also known as: Zinga

Zinc

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Chang Gung University: collaborator

MeSH Terms

Conditions

Hearing Loss, Noise-Induced; Tinnitus

Interventions

gluconic acid; Nizatidine

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• CHIH-YEN CHIEN, Professor

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 1, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share