Participant Information Sheet

Last updated: 15 July 2026

Placeholder notice. Fields shown in angle brackets < > are populated per trial (from the admin portal or trial design) and must be finalised and ethics-approved before recruitment. This page reproduces the approved Participant Information Sheet; the definitive version and Consent Form are presented in the TRipple app before you take part.

  • Trial name: <Insert specific trial name>
  • Trial opening date: <Insert date trial opened>
  • ClinicalTrials.gov ID: <Insert specific identifier>
  • Consent form number and version: <Insert unique number, matching consent form>
  • Consent form date: <Date PIS was finalised>
  • Chief Investigator: Dr William Sedley, Senior Lecturer in Neurology, Newcastle University

In brief

This is one of a series of studies on a new form of sounds that aim to cause a lasting quieting of tinnitus.

Volunteers in this trial…

  • Must have tinnitus, and must have some functioning hearing at their tinnitus frequency in the tinnitus ear(s)
  • Complete all trial-related activities using the TRipple app on their Android or iOS device
  • Complete questionnaires and simple tests to measure their hearing and tinnitus pitch
  • Listen to a special type of sound tailored to their hearing and tinnitus pitch on a daily basis
  • Give brief ratings of how loud and how annoying their tinnitus currently is, before and after listening to these sounds
  • Go through periods of time where they listen to the sounds daily, and other periods where they do not listen to the sounds
  • Still provide a daily tinnitus loudness and annoyance rating on days without listening to the sounds
  • Listen to different types of sounds over different time periods, to compare their effects. One type may be a placebo sound (i.e. not targeted to their tinnitus frequency)
  • May receive notifications or other prompts to complete trial-related activities
  • Are allowed to download the sounds to use in their own time, once the trial is complete
  • May not volunteer for the same trial twice, but can volunteer for further trials using the TRipple app, once the trial is complete.

What are the specific features of this trial compared to others run through the TRipple app?

Trial description: <Auto-populated from the text description entered for the trial in the admin portal>

Trial protocol: <Auto-populated from admin portal, specifying number of treatments, number of days in each, and listening duration per day>

The trial will terminate early if any of the following occur: <Auto-populated from trial design dashboard, e.g. number of days of non-engagement with app>

Overview

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.

There is some evidence from our previous research that regular daily listening to certain types of sounds can have a lasting quieting effect on tinnitus.

This study aims to compare how some different types of sounds compare in terms of the effect they have on tinnitus. The study may compare the sound types to each other, and one or more of the types included may be a placebo (meaning it is not targeted to your tinnitus frequency, but a different frequency).

The study follows a randomised blinded format, meaning that the order in which you listen to different types of sounds will be randomised, and you will not know what kind of sounds you are listening to, at any stage in the study.

The study is run entirely through the app, and takes a total of <auto-populated from trial duration information>. Participation is voluntary at every stage, and volunteers can withdraw at any time, with or without giving a reason.

Detailed description of the study

The study is run entirely through the TRipple app. While there is the opportunity to ask questions of the research team by e-mail, if you need information that is not available on the app, actually signing up for and taking part in the study does not involve any interaction between you and the research team.

The study involves the following:

  • Downloading the TRipple app and setting up an account
  • Reading of the detailed information in this Participant Information Sheet
  • Optionally, the chance to look at the Frequently Asked Questions section of the TRipple website, and to ask any questions to the research team that are not covered on the website or information sheet
  • After a minimum of 24 hours, a decision whether or not to take part, and digital signing of a consent form
  • Providing information such as age, sex, details about tinnitus, and other medical conditions or medications
  • Completing standardised questionnaires, including the Tinnitus Handicap Inventory, Tinnitus Functional Index, and Inventory of Hyperacusis Symptoms
  • Listening to a range of sounds in order to estimate the degree of any high-frequency hearing loss you might have (if any)
  • Listening to a range of sounds to determine the frequency (pitch) of your tinnitus
  • <Auto-populated from trial design dashboard> rounds of the following:
    • A <auto-populated> week period of listening to one type of sound (active or sham) daily, aiming for <auto-populated> minutes daily, which can be done while performing other activities if preferred
    • A <auto-populated> week 'washout' period with no daily listening
  • Daily ratings of how loud and how distressing your tinnitus currently is
  • Before and after each listening and washout period, repeating of the standardised questionnaires

Listening to the sounds in the study can be <auto-populated to specify whether headphones essential or headphones optional>.

The daily listening duration is a target we ask you to aim for, rather than an absolute requirement. You <can/cannot> listen for longer than this if you wish.

Sounds are stored on your device, so you can listen even if you are offline.

You can listen to the sounds at any time, day or night, and you do not need to be actively paying attention to them. However, please make sure you can clearly hear them.

The sounds do not need to sound particularly loud, and there is no evidence that louder is better.

Make sure to protect your hearing with safe sound listening practices. These are not unique to this study, and apply to all situations where you listen to sounds through personal devices. We advise the '60/60' rule, in which you set your device's volume to no more than 60% of its maximum volume, and listen for no more than 60 minutes at a time. Once you reach 60 minutes, we recommend a break of at least 60 minutes.

Once the results are available, you will be sent the results, or a link to them, if you have indicated that you want to be informed of these.

You are free to withdraw from the study at any time, and a link to do so is present on the main study screen in the TRipple app. This will not automatically delete data we hold about you. If you wish for your data to be deleted, please use the link to contact the research team, and ask for your data to be deleted. Once the trial is completed, it may no longer be possible to delete your anonymised research data, but only your personally identifiable information.

Am I eligible to take part in the study?

To be eligible for the study, you need to confirm that you…

  • Are at least 18 years of age
  • Are able to make a voluntary and informed choice about whether to take part
  • Experience tinnitus (persistent sound in one or both ears) for the majority of the time, provided that the level of background sound is not sufficiently loud to mask it. It is not important, for these purposes, whether you notice the tinnitus most of the time, provided it is there if you listen out for it.
  • 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.
  • Do not have tinnitus that is 'pulsatile', meaning that it gets significantly louder and quieter in time with your pulse. This type of tinnitus usually is described as a low-pitched 'whooshing' sound.
  • Have received medical attention for your tinnitus, if it began suddenly with sudden severe hearing loss

We would advise caution in participating if you find that your tinnitus gets louder or more bothersome while you are in a noisy environment, or just after being in one.

What is the evidence that these sounds can help tinnitus?

Our research group has developed a specific type of sounds intended to reduce the loudness of tinnitus when listened to regularly over a period of time. We have conducted an online trial (published research) which showed that regular listening to these sounds for 60 minutes daily for 6 weeks produced, on average, a 9% lasting reduction in the perceived loudness of tinnitus. This is not yet a large enough effect to be considered clinically meaningful. This trial is part of a series of trials which aim to make the technique more effective in quieting tinnitus, but it is presently uncertain whether we will be able to make the effect stronger.

How long will the study run for?

This study will run from <auto-populated from trial start date> until either <auto-populated from end date>, or until <auto-populated from recruitment target> participants have completed the study. In exceptional circumstances, we may occasionally need to terminate a study early. We intend to run a series of studies, and these dates and numbers only refer to this specific study.

What do the sounds in the study sound like?

The sounds are based on harmonic complexes with a flat spectrum, which have a specific modification applied. They sound like slightly buzzy, synthetic musical notes, with a random pitch, which play one at a time, rising and falling slowly over a few seconds. Examples of the sounds are available on the study website.

Do I need to listen with headphones?

For this study we <auto-populated with whether headphones are mandatory or optional>. We would suggest using the highest quality headphones available. Ideally, we suggest using headphones physically connected with a cable. Bluetooth can sometimes introduce some loss of fine detail and higher frequency content. We are presently unsure how much of a difference this makes to the effectiveness of the sounds.

I use a hearing aid (or cochlear implant). Can I still take part in the study?

As long as you have hearing loss that is not severe or profound in the higher frequencies, with the hearing device switched on, then you can take part. It is up to you whether to listen to the sounds with your hearing device switched on or off. If the sounds used in the study turn out to have an effect on tinnitus, then it is presently unclear whether the use of a hearing aid or cochlear implant will interfere with, or enhance, that effect.

Who is funding and running the study?

The study is being run by Newcastle University's Translational and Clinical Research Institute. The lead researcher is Dr William Sedley, Senior Lecturer in Neurology, Newcastle University.

What will the results of the study be used for once the trial is complete?

This study is one in a series of studies aiming to improve the effectiveness of the sounds for quieting tinnitus. The principle is that the exact type of sounds showing the best effect in one study will be used as the basis for the next study, which will test further changes, making the sounds better with each iteration. Over time, we hope the sounds will evolve into the most effective possible version.

Our long-term goal is to make the best possible type of sounds for quieting tinnitus, and learn how to use these for maximal effect. We would like to make these widely available around the world, at an affordable cost, including through TRipple and other apps, and by building the technology into everyday audio devices such as smartphones, headphones, hearing aids and televisions.

What do I have to gain by taking part?

By taking part, you 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 your 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 you perceive a benefit from listening to the sounds used in the study then you will be able to download them to use even after you have completed the study. For a number of reasons, we are unable to provide any financial incentive for taking part in the study. These include limited funding, and the risk of compromising the study by recruiting participants with motivations other than helping to advance tinnitus science and see if it helps their own tinnitus.

If I feel that the sounds used in the study help my tinnitus, am I able to continue to use these?

Yes: you will have the option to download and save the sounds for future use. You can also choose to keep participating in further trials, which may involve further advances to the sounds.

Are there any risks or downsides to taking part?

The study requires a significant time commitment, mainly in listening to the sounds, and reporting back each day on how long you spent listening. We guide you through steps to ensure that the sounds you listen to are kept at a volume that is comfortable and safe. However, because we cannot directly measure the volume of the particular speakers or headphones you will be using, we cannot absolutely guarantee that the sounds will be at a low enough volume to not cause any hearing damage. That said, the sounds are in most ways similar to music and other sounds commonly listened to, and there is no reason to think they should pose any greater risk to hearing than listening to music. In fact, the sounds are likely to be less hazardous to hearing than most music. The very act of taking part in a research study, and focusing on your tinnitus, can change the way you perceive the tinnitus, which can sometimes make it seem more intrusive. In our previous study, we found that on average people found their tinnitus became less bothersome and less intrusive, whether they listened to the active or placebo sounds. There may also be coincidental changes that occur in tinnitus for other reasons besides the study, and it may seem natural to assume that taking part in the study has caused these changes. Finally, while most people find that external sounds make their tinnitus quieter and less noticeable, there is a minority of people whose tinnitus is made worse by external sounds, and can sometimes remain worse for a period of time after listening to these sounds. We advise considerable caution in taking part in the study for people whose tinnitus behaves in this way. In all cases, we would advise against taking part in the study if you notice that the sounds used in the study cause your tinnitus to get significantly louder while you are listening to these sounds, or in the period of time after you have listened to them.

What will happen to information I provide as part of the study?

All data you provide will be stored confidentially, and used only for the purposes of conducting the study and analysing the results. While the study is ongoing, your data will be securely stored on the study website linked to the app. Once your participation has finished, the data will be transferred to a secure server in Newcastle University. At this point, any personally identifiable information will be removed, and the data cannot be specifically linked to you.

Anonymised data will be published in scientific journals and presented at scientific meetings. It may also be made available for other researchers to analyse.

Information you provide is confidential, and will be stored and handled according to General Data Protection Regulation (GDPR). You have the option to ask for your information to be deleted, in which case we will delete all information we hold about you, and this will not feature as part of the study. This might only be possible while the study is ongoing, before your data is anonymised and transferred to the Newcastle University server.

Although all data is stored confidentially and securely, we also take steps to minimise the level of personal information we collect about you. As such, the only information we store that can be linked to you as a person is your e-mail address, and a password of your choosing. Other information we collect and store includes your age, sex, and details of your tinnitus and related symptoms.

Has this study been subject to ethical review?

The study has been through the ethical review process in Newcastle University, and been granted a favourable opinion. Its reference number is <Ethics ref number>.

Can I take part in the study more than once?

The app will not allow you to enlist for the same trial twice, which is necessary to maintain scientific validity. Please do not create a new account to re-register for a trial you have already participated in. There will be various trials over time, and you are able to participate in as many of these as you like, but just not the same trial multiple times. If you find the sounds from a trial useful for your tinnitus then you will be able to download these after the trial is finished, to use as you wish.

What if there is a problem, or I am unhappy about any aspect of the study?

We advise that the first port of call in this case would be to contact the lead researcher, using the complaint link in the app. If you are unsatisfied with the response you receive, or you do not wish to contact the research team, then you can raise the issue in writing with the Research Integrity and Governance Manager:

Newcastle University King's Gate Newcastle upon Tyne NE1 7RU [email protected]

If you have any questions not covered in this document then please contact the research team by e-mail.