Online sound therapy for chronic tinnitus using a novel type of sound
| ISRCTN | ISRCTN18390012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18390012 |
| Secondary identifying numbers | 4574/2020, 222071/Z/20/Z |
- Submission date
- 25/07/2024
- Registration date
- 21/08/2024
- Last edited
- 16/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Tinnitus, the sensation of ringing or other sounds in one or both ears, affects 10-15% of people on a long-term basis, and at present there is no established treatment to silence or suppress this sound. Researchers at Newcastle University, led by Dr William Sedley, have developed a specific type of sound intended to reduce the loudness of tinnitus when listened to regularly over a period of time. This study aims to test the effectiveness of this sound in quietening tinnitus and also to explore the feasibility of a fully online longitudinal study of this kind.
Who can participate?
Anyone over 18 years old who has subjective tinnitus, has access to a phone or a computer to download the sound files, and is able to clearly hear those sounds playing through their headphones/earphones.
What does the study involve?
1. Listening to a range of sounds in order to estimate hearing, type, and frequency of tinnitus
2. A 6-week period of listening to one type of sound (active or sham) daily, which can be done while performing other activities if preferred. Each day, participants record how long they listened to the sound, but there is no set time of required listening - it is the volunteer's choice (as a suggestion, 30-60 minutes at a time is recommended)
3. A 3-week 'washout' period with no daily listening
4. A further 6-week period of daily listening (to the other type of sound), and a further 3-week washout period
5. Completing questionnaires before and after each listening and washout period about hyperacusis (sound sensitivity), tinnitus loudness, and the impact of tinnitus at the time
What are the possible benefits and risks of participating?
Participants would be helping to advance medical science in the field of tinnitus, and working towards better treatment for the hundreds of millions of people worldwide with this condition. Furthermore, there is a chance that taking part might result in some improvement in their tinnitus. This might be difficult to tell for certain, as many factors can influence the perceived loudness of tinnitus, including naturally occurring changes over time, and also the very act itself of taking part in a study. If participants perceive a benefit from listening to the sounds used in the study then they will be able to download or continue to access these even after they have completed the study. The researchers are unable to provide any financial incentive for taking part in the study.
Where is the study run from?
Newcastle University (UK)
When is the study starting and how long is it expected to run for?
July 2020 to April 2022
Who is funding the study?
1. Royal National Institute for Deaf People (UK)
2. Wellcome Trust (UK)
3. Masonic Charitable Foundation (UK)
Who is the main contact?
Dr Ekaterina Yukhnovich, Kate.Yukhnovich@newcastle.ac.uk
Contact information
Public, Scientific
Newcastle University
Newcastle upon Tyne
NE1 7RU
United Kingdom
| Phone | +44 (0)191 208 6000 |
|---|---|
| Kate.Yukhnovich@newcastle.ac.uk |
Principal Investigator
Newcastle University Medical School
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom
| Phone | +44 (0)191 208 6000 |
|---|---|
| william.sedley@newcastle.ac.uk |
Study information
| Study design | Fully online interventional randomized blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Home, Internet/virtual |
| Study type | Treatment |
| Study type | Participant information sheet |
| Scientific title | Online sound therapy for chronic tinnitus using a novel cross-frequency covariance-cancelling stimulus |
| Study objectives | A novel type of sound modulation was created, aiming to reduce the covariance of neuronal activity in different frequency channels within and surrounding the tinnitus frequency (or frequency range). The hypothesis was that listening to sounds with a modulation applied to tones within the tinnitus frequency range of each participant would reduce the self-rated tinnitus loudness of that participant and that this loudness reduction would not occur following a 'sham' condition where the same participants listen to sounds with a modulation applied to tones far outside of their tinnitus frequency range. |
| Ethics approval(s) |
Approved 11/08/2020, Research, Policy, Intelligence and Ethics Team (Newcastle University, Newcastle upon Tyne, NE1 7RU, United Kingdom; +44 (0)191 208 6000; res.policy@ncl.ac.uk), ref: 4574/2020 |
| Health condition(s) or problem(s) studied | Tinnitus |
| Intervention | Participants are randomised to receive one of three types of modulated sound: 1. Notch degradation 2. Amplitude modulation 3. Phase modulation Randomisation method: block randomisation. There were six blocks. The first three had the sham condition as the first listening period and the last three had the active condition as the first listening period. The first and fourth blocks were amplitude-modulated sounds, the second and fifth were notch degradation sounds, the third and sixth were phase-modulated sounds. Within their modulation group, participants are randomly assigned to listen to either sham or active sound therapy first (a sound with a modulation within their tinnitus frequency range, or outside of it) for 6 weeks, and then, after a 3-week washout period, they cross over to the other condition for a further 6 weeks of listening and a 3-week washout period. As the difference between the conditions is not easily discernible, they do not know which condition they are in. The carrier sounds are hour-long sequences of non-overlapping 4-second broadband (spectrum 1-16 kHz) harmonic complexes. In the first condition, there is a frequency-specific notch degradation applied to the sounds. For the second and third conditions, dynamic spectral ripple modulations are applied to tinnitus or non-tinnitus sections of the sounds, with the spectral modulation rate also being constantly modulated over a one-octave range. There are two alternative implementations of this modulation, which are applied either as an amplitude modulation (range 0-2) or phase modulation (range 0 to 2 π). |
| Intervention type | Other |
| Primary outcome measure | Tinnitus loudness measured using a numerical rating scale before the start of the listening period and after the end of the listening period |
| Secondary outcome measures | 1. Tinnitus bothersomeness measured using the Tinnitus Handicap Inventory, just before and immediately after each 6-week listening period and immediately after the 3-week washout period 2. Tinnitus bothersomeness measured using the Tinnitus Functional Index, just before and immediately after each 6-week listening period and immediately after the 3-week washout period 3. Sound sensitivity/hyperacusis measured using the Hyperacusis Questionnaire, just before and immediately after each 6-week listening period and immediately after the 3-week washout period |
| Overall study start date | 01/07/2020 |
| Completion date | 01/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 x 3 clusters |
| Total final enrolment | 560 |
| Key inclusion criteria | 1. At least 18 years old 2. Able to make a voluntary and informed choice about whether to take part 3. Experience tinnitus (persistent sound in one or both ears) for the MAJORITY of the time, provided that the level of background sound is not loud enough to mask it. It is not important whether you notice the tinnitus most of the time, provided it is there if you listen out for it |
| Key exclusion criteria | 1. Do NOT have hearing loss that is in the 'severe' or 'profound' range at the higher frequencies. Where there are such high degrees of hearing loss, it is unlikely the sounds used in the study will have any effect on the tinnitus. If you do have this level of hearing loss, but USE A HEARING AID OR COCHLEAR IMPLANT to correct this, then you CAN still take part, though we cannot guarantee that the sounds will have the same effect when used with such a device; 2. Do NOT have tinnitus that is 'PULSATILE', meaning that it gets significantly louder and quieter in time with your pulse. This type of tinnitus is usually described as a low-pitched 'whooshing' sound. |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 01/02/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle upon Tyne
NE1 7RU
United Kingdom
Sponsor information
University/education
Newcastle University
King's Gate
Newcastle upon Tyne
NE1 7RU
England
United Kingdom
| Phone | +44 (0)191 208 6000 |
|---|---|
| rec-man@ncl.ac.uk | |
| Website | http://www.ncl.ac.uk/ |
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- RNID
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Wellcome, WT
- Location
- United Kingdom
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The Masonic Charitable Foundation, MCF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A presentation about this study was done in 2023 at the TRI conference. We plan a publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 25/07/2020 | 30/07/2024 | No | Yes |
Editorial Notes
25/07/2024: Study's existence confirmed by the Research, Policy, Intelligence and Ethics Team at Newcastle University.
