We are working in collaboration with Earswitch Ltd. to test if an otoscope (a small camera) can be used to detect voluntary rumbling in the ear.
The information below will explain what the research is about and what your participation will involve. Please get in contact with us (see details below) if you are interested in taking part.
What is the purpose of the project?
The Earswitch is an ear-based assistive communication device. It uses an in-ear camera to detect when a muscle in the ear, called the tensor tympani (TT), is contracted or tightened. When the tensor tympani muscle contracts you may hear a dull rumbling sound, this is known as “ear rumbling”. Some people can voluntarily ear rumble by purposefully contracting their tensor tympani on-demand.
The Earswitch senses your ability to ear rumble so that it can be used for communication. For some individuals, the Earswitch has the potential to be a communication device when other communication technologies do not work. In addition, there is the possibility that the ability to ear rumble may be preserved until later stages of degenerative diseases (e.g., motor neurone disease), allowing people to communicate for longer.
This project is looking at how we can develop the Earswitch into a useful device for those who need it. To do this, we want to understand how well different people can ear rumble and how well the Earswitch fits with other assistive technology. Your input into this process is invaluable for making the Earswitch the best device it can be.
Who can participate?
We are looking to recruit participants aged 18+ who can voluntarily contract the tensor tympani muscle in their ear (are able to “ear rumble”).
This study will include both participants with and without assistive technology needs.
Do I have to take part?
It is completely up to you to decide if you would like to participate.
Before you decide to take part, we will describe the project and go through this information sheet with you. If you agree to take part, we will then ask you to sign a consent form. However, if at any time you decide you no longer wish to take part in this project you are free to withdraw, without giving a reason.
What will I be asked to do?
The purpose of this study is to better understand how well you can "ear rumble". We'll collect data to improve the robustness of detecting voluntary eardrum contractions with an otoscope and to get your feedback about how comfortable and usable you think the otoscope with an earbud is.
This study should take no longer than one and a half hours to complete. The study will be split into four distinct parts:
- Pre-study Questionnaire [15 mins]
- Otoscope Insertion by Carer or Experimenter [10 mins]
- Data Collection of "Ear Rumbling" [25 mins]
- Interactive Applications [15 mins]
Phase 1: Pre-study questionnaire
Firstly, you will be asked to complete a demographic questionnaire about yourself (e.g., age, gender). You will then be asked to complete a questionnaire to understand what, if any, assistive technology you currently use.
During this, we will agree on a signal with you so that you can indicate if you wish to stop the study or want the device to be removed. During the study you will be asked to wear the otoscope and earbud, however, you will not be asked to remove any assistive communication devices you currently use.
Phase 2: Earswitch Insertion by Carer or Experimenter
Following this, you will select an earbud size (see Figure 1), with the help of the experimenter or your carer, which will be inserted into your ear. You will then be asked if it is comfortable or whether you would like to try a different size according to the comfort or fit of the earbud.
Once you are happy with the size of the earbud, your carer or the experimenter will insert the otoscope into your ear (see Figure 2). This involves putting the small camera into your ear and positioning it so that it can see your ear drum (see Figure 3).
During this procedure, please let your carer or the experimenter know if it is uncomfortable or if you wish to stop. This should be similar to putting a regular earbud into your ear.
Once this is complete, we will ask you some questions about the comfort of the device, and how easy you felt the insertion process was. The experimenter will then measure how well the device fits in your ear and will take a close-up picture of the otoscope in your ear. The photo will be taken to make sure you cannot be identified and will help us to understand how well it fits in your ear.
Phase 3: Data Collection of TT Muscle Contraction
Next, we will ask you to perform a series of ear rumbles and we will record videos from the ear of your ear drum.
We will ask you to ear rumble based on a number of different stimuli presented to you either visually on a screen or audibly through speakers. The purpose of this is to see how well you can ear rumble and to provide data for improving the accuracy of the otoscope detecting voluntary eardrum movements.
There are five tasks you will be asked to do which involve:
- Ear rumbling when a target appears;
- Ear rumbling at the end of a countdown;
- Ear rumbling twice in quick succession (like a double click on a mouse);
- Ear rumbling multiple times in a row in a short period of time (for example, 3 seconds);
- Holding an ear rumble for a pre-defined amount of time (for example, 1 second).
Following these tasks, we will record your eardrum when you perform “normal” tasks to make sure that the otoscope does not accidentally activate when it shouldn’t. These normal tasks include communicating with the researcher and where possible drinking some water, yawning, and moving your head.
During these tasks you will not get any immediate feedback from the system. Instead, it will be recording the data which we will analyse after you have finished the study. The videos will be recorded using the otoscope in your ear and will therefore only contain images of your ear drum. This means that no one will be able to identify you from the videos taken as we will not store any personally identifiable data alongside the videos.
During the data collection, we will ask you to complete questionnaires about your experiences with the otoscope, including the comfort of the fit and how easy it was to use.
Phase 4: Interactive Applications
Following the data collection, you will have the opportunity to interact with some interfaces. There will be three interfaces which you can try which involve:
- Text entry using an on-screen (switch scanning) keyboard
- A target practice task that provides immediate feedback
- A game
You can complete these applications in any order you wish, and for as long as you wish. The purpose of these applications is to gather feedback about using the device for interaction.
At the end of the study, you will have the opportunity to provide us with your contact details (i.e., an email address or telephone number) in case you would like to receive updates about the study results or if you would like to participate in future studies involving ear rumbling.
This information, if you choose to provide it, will only be accessible by the named University of Bath researchers at the bottom of this page.
What are the exclusion criteria (are there reasons why I should not take part)?
There are no exclusion criteria if you can provide consent and decide for yourself whether you wish to take part.
You should also be able to answer basic yes/no questions and provide a signal to indicate if you wish the study to stop.
What are the possible benefits of taking part?
There are no direct benefits or funding given to you for taking part in the project.
However, the information that you and other participants provide in this project will help us to further develop and understand the Earswitch as an assistive communication device. This has the potential to help many people with assistive technology needs where other technologies fail.
What are the possible disadvantages and risks of taking part?
There are no disadvantages to you taking part in the project. If you feel uncomfortable at any time during the project you are free to stop the study by informing your carer or the experimenter.
This study involves a camera being placed in your ear, and it may not be possible to see the ear drum due to ear wax. If this is the case, we will not be able to collect the required data.
Will my participation involve any discomfort or embarrassment?
You may feel some discomfort when the otoscope is inserted into your ear. However, this should be minor, and we do not expect you to feel any other discomfort or embarrassment if you take part in the project. If, however, you do feel uncomfortable or appear upset at any time, the research will stop.
If at any time you wish to withdraw from the study, you are free to do so without any adverse consequences.
How will we use information about you?
We will need to collect personal information from you for this research project. This information will include your name, age, and contact details which is required to organise the study appointment. The videos of your ear drum collected during the data collection will be used to train and analyse software to automatically to detect ear rumbles. All data collected during the project will be anonymised and will not contain personally identifiable information.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a numeric code number instead and will be stored separately to your name or any other identifying information. No pseudonymisation will occur, meaning that your results will be anonymous and therefore, we won’t know which results belong to you.
We will keep all information about you safe and secure. None of the data will leave the UK. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
Who will have access to the information that I provide?
Both the University of Bath and Earswitch Ltd will have access to the information that you provide.
The data will be anonymised and securely shared with Earswitch Ltd to analyse in the future for the development of more robust algorithms for detecting voluntary tensor tympani movement.
Who has reviewed the project?
This project has been given a favourable opinion by the NHS Research Ethics Committee [reference IRAS ID: 317435].
How can I withdraw from the project?
You can withdraw from the project at any time without providing a reason for doing so and without any repercussions.
Upon completion of the study, it will not be possible to withdraw your data because your answers will be anonymous and therefore, we won’t know which answers belong to you. Your individual results will not be identifiable in any way in any presentation or publication.