Defining a minimally clinically identifiable difference in the minimum level at which tinnitus is completely masked
| ISRCTN | ISRCTN91448124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91448124 |
| Secondary identifying numbers | NRF - 2023R1A2C1002929 |
- Submission date
- 30/06/2023
- Registration date
- 03/07/2023
- Last edited
- 08/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Minimum masking level (MML) is a method of measuring the minimum intensity of a masking sound to mask tinnitus. If the MML decreases after tinnitus treatment, the patient's perception of tinnitus decreases. The MML has been suggested to be an important indicator of changes in neural activity that can detect tinnitus signals; however, no evidence exists showing that the MML is a reliable way to measure changes in tinnitus loudness. Therefore, once the minimally clinically identifiable difference (MCID) of a measurement method using the MML is determined, it can be a valid and effective measure of tinnitus loudness reduction in patients with chronic tinnitus. This study aimed to develop a reliable measure of loudness changes in tinnitus using the MCID of the MML.
Who can participate?
People aged 19 to 75 years with chronic subjective tinnitus
What does the study involve?
Participants will be allocated to receive treatment for 3 months and will complete a number of tests and questionnaires 3 months before, during, and after treatment. 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 sessions lasting about 2 weeks. Sound therapy will be provided for 2 hours a day for 3 months using a self-developed sound therapy application and headphones. The duration of the daily sound therapy will be recorded using the application's data-logging system.
What are the possible benefits and risks of participating?
Some participants may experience a reduction in the loudness of their tinnitus or an improvement in tinnitus. There are no risks expected.
Where is the study run from?
Hallym University (South Korea)
When is the study starting, and how long is it expected to run for?
June 2023 to June 2024
Who is funding the study?
National Research Foundation of Korea (NRF) (South Korea)
Who is the main contact?
Prof. In-Ki Jin, inkijin@hallym.ac.kr
Contact information
Public
125, Sakju-ro
Chuncheon-si
24253
Korea, South
 ORCID ID |
0009-0009-2604-569X |
|---|---|
| Phone | +82 (0)10 7387 2711 |
| inkijin@hallym.ac.kr |
Study information
| Study design | Repeated measures within-subject study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home, Laboratory |
| Study type | Other, Treatment |
| Participant information sheet | https://www.nrf.re.kr/index |
| Scientific title | Quantifying tinnitus perception improvement: deriving the minimal clinically important difference of the minimum masking level |
| Study objectives | The minimum masking level (MML) can be a valid and effective way to measure tinnitus loudness reduction in patients with chronic tinnitus if the minimally clinically identifiable difference (MCID) is determined. |
| Ethics approval(s) |
Approved 08/06/2023, The Institutional Review Board of Hallym University (Hallym University 1 Hallymdaehak-gil, Chuncheon, 24252, Korea, South; No telephone number provided; irb@hallym.ac.kr), ref: HIRB-2023-033 |
| Health condition(s) or problem(s) studied | Chronic subjective tinnitus |
| Intervention | 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 sessions lasting about 2 weeks. Sound therapy will be provided for 2 h a day for 3 months using a self-developed sound therapy application and headphones. The duration of the daily sound therapy will be recorded using the application's data-logging system. |
| Intervention type | Behavioural |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 07/06/2023 |
| Completion date | 06/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 19 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 74 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 05/07/2023 |
| Date of final enrolment | 11/11/2023 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Chuncheon
24252
Korea, South
Sponsor information
Government
201, Gajeong-Ro, Yuseong-Gu
Daejeon
34113
Korea, South
| Phone | +82 (0)42 869 6114 |
|---|---|
| basicresearch@nrf.re.kr | |
| Website | https://www.nrf.re.eng/index |
"ROR" |
https://ror.org/013aysd81 |
Funders
Funder type
Government
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- 한국연구재단이 창의적 연구와, National Research Foundation (South Korea), NRF
- Location
- Korea, South
Results and Publications
| Intention to publish date | 15/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Research using these data will be published in a peer-reviewed hearing journal |
| IPD sharing plan | The datasets generated and/or analyzed in the current study are available upon request from In-Ki Jin (inkijin@hallym.ac.kr) The type of data that will be shared: Excel spreadsheet Dates of availability: 01/03/2024 Whether consent from participants was required and obtained: Yes Comments on data anonymization: The data will be anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/02/2025 | 08/07/2025 | Yes | No |
Editorial Notes
08/07/2025: Publication reference added.
11/06/2024: The following changes were made to the study record:
1. The scientific title was changed from 'Development of predicting tinnitus loudness change based on minimum masking level measurement method and identification of minimally clinically identifiable difference' to 'Quantifying tinnitus perception improvement: deriving the minimal clinically important difference of the minimum masking level'.
2. The primary and secondary outcome measures and inclusion criteria were updated.
3. The target number of participants was changed from 46 to 72.
4. The total final enrolment number was changed from 40 to 74.
5. The recruitment start date was changed from 01/08/2023 to 05/07/2023.
6. The recruitment end date was changed from 31/10/2023 to 11/11/2023.
10/10/2023: The total final enrolment was added.
30/06/2023: Study's existence confirmed by the Institutional Review Board of Hallym University.
