The impact of a daily sound therapy hour on tinnitus relief for people with chronic subjective tinnitus (ringing in the ears)
| ISRCTN | ISRCTN59618689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59618689 |
| Secondary identifying numbers | NRF 2018R1C1B6003765 |
- Submission date
- 24/11/2021
- Registration date
- 24/11/2021
- Last edited
- 06/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Sound therapy has been considered a treatment option for people with subjective tinnitus. Several studies on sound therapy have reported that some participants, but not all, show significant relief from tinnitus with its use. Therefore, determining the factors influencing the effect of sound therapy is important to increase its effect. A major factor that affects the effectiveness of sound therapy is the duration of sound therapy, with several studies reporting that the longer the duration of sound therapy, the greater the tinnitus relief effect. Although the relationship between the duration of sound therapy and the tinnitus relief effect has been confirmed in previous studies to some extent, the relationship between the daily duration of sound therapy and the tinnitus relief effect remains unclear. In the present study, we aimed to measure the tinnitus relief effect according to the duration of daily sound therapy.
Who can participate?
People with chronic subjective tinnitus
What does the study involve?
Participants will be randomly allocated to receive sound therapy or treatment as usual for 3 months, they completed a number of tests and questionnaires at baseline and 3-month follow-up
What are the possible benefits and risks of participating?
Benefit: Participants can reduce their tinnitus loudness or adverse of tinnitus
Risk: None
Where is the study run from?
Hallym University (South Korea)
When is the study starting and how long is it expected to run for?
July 2018 to October 2021
Who is funding the study?
This work was supported by the Commercializations Promotion Agency for R&D Outcomes (Funding number: 2020 Customer Demand Correspondence Research-0002) and by the National Research Foundation of Korea grant funded by the Korean government (Ministry of Science and ICT; Grant NRF-2018R1C1B6003765).
Who is the main contract?
Prof. In-Ki Jin, inkijin@gmail.com
Contact information
Scientific
1 Hallymdaehak-gil
Division of Speech Pathology and Audiology
Research Institute of Audiology and Speech Pathology
Chuncheon
24252
Korea, South
 ORCID ID |
0000-0002-0834-5981 |
|---|---|
| Phone | +82-33-248-2221 |
| inkijin@hallym.ac.kr |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | 40714 PIS v4.2 01Jun2020.pdf |
| Scientific title | The impact of daily hours of sound therapy on tinnitus relief for people with chronic tinnitus: a randomized controlled study |
| Study objectives | The tinnitus relief effect increases with a longer duration of daily sound therapy. |
| Ethics approval(s) | Approved 10/07/2020, The institutional review board of Hallym University (Hallym University 1 Hallymdaehak-gil, Chuncheon, Gangwon-do, Republic of Korea, 24252; no telephone number provided; irb@hallym.ac.kr), ref: HIRB-2020-069 |
| Health condition(s) or problem(s) studied | Tinnitus relief for people with chronic subjective tinnitus |
| Intervention | Forty-three chronic subjective tinnitus participants were randomly assigned to three groups according to the duration of daily sound therapy (1hour, 3hour, and 5hour groups), and mixing point-based sound therapy was administered for 3 months. Sound therapy was administered using a self-developed sound therapy application and headphones. The duration of daily sound therapy was recorded via a data logging system of the application. In each group, the efficacy of sound therapy was determined based on changes in the tinnitus loudness level, Visual Analog Scale for loudness score, the Korean version of Tinnitus Primary Function Questionnaire score, and the effect size value between the baseline and 3-month time points. Randomization by excel spreadsheet (Microsoft, Redmond, Washington, USA) was used for allocating participants. This randomization program assigned 58 participants from number 1 to number 58 and randomly changes the order. Those assigned to numbers 1 to 20 were assigned to a 1-hour group, people assigned to numbers 21 to 39 were assigned to a 3-hour group, and the rest were assigned to a 5-hour group. |
| Intervention type | Behavioural |
| Primary outcome measure | The efficacy of sound therapy was determined based on changes in the tinnitus loudness level, Visual Analog Scale for loudness score, the Korean version of Tinnitus Primary Function Questionnaire score, and the effect size value between the baseline and 3-month time points. |
| Secondary outcome measures | Hearing status according to the three groups (1H, 3H, 5H) was measured using puretone average at baseline and 3-month follow-up. |
| Overall study start date | 01/07/2018 |
| Completion date | 06/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 43 |
| Key inclusion criteria | 1. Persistent presence of tinnitus for over 1 year 2. Diagnosis of sensorineural tinnitus from medical doctor 3. Presence of discomfort or difficulty due to tinnitus 4. Pure-tone hearing thresholds of <40 dB hearing level at 0.5, 1, and 2 kHz 5. Average score of the Korean version of Tinnitus Primary Function Questionnaire (K-TPFQ) >30 points 6. Willingness to receive tinnitus sound therapy for 6 months 7. Willingness to wear headphones and use the sound therapy app for a set amount of time each day 8. Familiarity with smartphone |
| Key exclusion criteria | 1. Currently receiving tinnitus-related rehabilitation or treatment 2. Presence of current otologic problems (e.g., acoustic tumor, Meniere’s disease, and otitis media) or audiological problems (e.g., hyperacusis) 3. Psychiatric illness 4. Hearing aid user 5. Involvement in tinnitus-related litigation |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 28/02/2021 |
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 | +82-42-869-6114 |
|---|---|
| basicresearch@nrf.re.kr | |
| Website | http://www.nrf.re.kr/nrf_eng_cms/ |
"ROR" |
https://ror.org/013aysd81 |
Government
13 Chungjeong-ro
Seodaemun-gu
Seoul
03737
Korea, South
| Phone | +82-2-736-9799 |
|---|---|
| sknah@compa.re.kr | |
| Website | https://www.compa.re.kr/ |
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
No information available
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The research with this data will be published as one of hearing journals. |
| IPD sharing plan | The data obtained in this study will be provided in the appendices of the submitted manuscript of the journal. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 4.2 | 01/06/2020 | 24/11/2021 | No | Yes |
| Results article | 22/07/2022 | 25/07/2022 | Yes | No | |
| Protocol file | 06/10/2022 | No | No |
Additional files
Editorial Notes
06/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
25/07/2022: Publication reference added.
14/06/2022: The following changes were made to the trial record:
1. The scientific title was changed from 'The impact of a daily sound therapy hour on tinnitus relief for people with chronic subjective tinnitus: a randomized controlled study' to 'The impact of daily hours of sound therapy on tinnitus relief for people with chronic tinnitus: a randomized controlled study'.
2. The intention to publish date was changed from 30/06/2022 to 30/09/2022.
24/11/2021: Trial's existence confirmed by the institutional review board of Hallym University.
