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

Quantifying tinnitus perception improvement: deriving the minimal clinically important difference of the minimum masking level

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91448124

Enrollment

Registered

2023-07-03

Start date

2023-07-05

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic subjective tinnitus Ear, Nose and Throat Tinnitus

Interventions

Participants will receive tinnitus counseling and sound therapy. The counseling will be educational, providing information about tinnitus and how to deal with it, and will consist of six to twelve ses

Eligibility

Sex/Gender

All

Inclusion criteria

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 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 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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 11/06/2024: 1. Hearing threshold is measured using the puretone audiometry (decibels) at baseline and 3 months 2. Tinnitus frequency and loudness are measured using tinnitogram (Herz and decibels) at baseline and 3 months 3. Quality of life impairment due to tinnitus is measured by the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ, 100 points) at baseline and 3 months Previous secondary outcome measures: 1. Hearing threshold is measured using the puretone audiometry (decibels) at baseline, 1.5 months, and 3 months 2. Tinnitus frequency and loudness are measured using tinnitogram (Herz and decibels) at baseline, 1.5 months, and 3 months 3. Loudness and annoyance of tinnitus are measured using the visual analog scale (100 points) at baseline, 1.5 months, and 3 months 4. Quality of life impairment due to tinnitus is measured by the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ, 100 points) at baseline, 1.5 months, and 3 months	—

Measure

Time frame

Current secondary outcome measures as of 11/06/2024: 1. Hearing threshold is measured using the puretone audiometry (decibels) at baseline and 3 months 2. Tinnitus frequency and loudness are measured using tinnitogram (Herz and decibels) at baseline and 3 months 3. Quality of life impairment due to tinnitus is measured by the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ, 100 points) at baseline and 3 months Previous secondary outcome measures: 1. Hearing threshold is measured using the puretone audiometry (decibels) at baseline, 1.5 months, and 3 months 2. Tinnitus frequency and loudness are measured using tinnitogram (Herz and decibels) at baseline, 1.5 months, and 3 months 3. Loudness and annoyance of tinnitus are measured using the visual analog scale (100 points) at baseline, 1.5 months, and 3 months 4. Quality of life impairment due to tinnitus is measured by the Korean version of the Tinnitus Primary Function Questionnaire (K-TPFQ, 100 points) at baseline, 1.5 months, and 3 months

—

Countries

Korea, South

Contacts

Public ContactTae-Jun Jin

inkijin@hallym.ac.kr+82 (0)10 7387 2711

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026