Defining a minimally clinically identifiable difference in the minimum level at which tinnitus is completely masked

Not Applicable

Completed

• Conditions: Chronic subjective tinnitus; Ear, Nose and Throat; Tinnitus

• Registration Number: ISRCTN91448124
• Lead Sponsor: ational Research Foundation of Korea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-03
• Study Completion: 2024-06-06
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Current inclusion criteria as of 11/06/2024:
1. Subjective chronic tinnitus
2. Participants complaining of discomfort and irritation due to tinnitus
3. Pure-tone hearing thresholds of <40-dB hearing level at 0.5, 1, and 2 kHz
4. Average score of the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ) >30 points
5. Participants willing to undergo pure tone audiometry, tinnitogram, minimum masking Level (MML), the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ), and Clinical Global Impression (CGI)

Previous inclusion criteria:
1. Subjective chronic tinnitus
2. Participants complaining of discomfort and irritation due to tinnitus
3. Pure-tone hearing thresholds of <40-dB hearing level at 0.5, 1, and 2 kHz
4. Average score of the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ) >30 points
5. Participants willing to undergo pure tone audiometry, tinnitogram, minimum masking Level (MML), visual analog scale (VAS), the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ), and Clinical Global Impression (CGI)

Exclusion Criteria

1. Participants experiencing a scientific disease (acoustic tumor, otitis media, hyperacusis, etc) or mental disorder
2. Participants currently undergoing litigation associated with tinnitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 11/06/2024:<br>1. Tinnitus loudness is measured using the Clinical Global Impression (CGI, 5 points) at 3 months<br>2. Loudness of tinnitus is measured using the minimum masking level (MML, decibels) at baseline and 3 months<br><br>Previous primary outcome measures:<br>1. Tinnitus loudness is measured using the Clinical Global Impression (CGI, 5 points) at 1.5 and 3 months<br>2. Loudness of tinnitus is measured using the minimum masking level (MML, decibels) at 1.5 and 3 months