Tinnitus Week 2022 podcast transcript

For our Tinnitus Week 2022 podcast, we discussed the potential of a Tinnitus Biobank for tinnitus research. Nic Wray, Communications Manager at the British Tinnitus Association, was joined by David Stockdale, Chief Executive of the British Tinnitus Association, and Will Sedley, who is the Wellcome Trust Clinical Research Fellow and Consultant Neurologist at Newcastle University. Listen to the podcast


Nic Wray 0:00
Hello and welcome to the latest in our series of That Tinnitus Podcast and this edition is going to be talking about a tinnitus biobank and the potential that that might have in tinnitus research. And joining the podcast today are David Stockdale who is the Chief Executive of the British Tinnitus Association, and Will Sedley, who is the Wellcome Trust Clinical Research Fellow and Consultant Neurologist at Newcastle University. My name is Nic Wray, I’m the Communications Manager at the British Tinnitus Association and I will be facilitating this session, but David and Will will be leading the conversation so I will ask them both to introduce themselves now, so David.

David Stockdale 0:52
Thanks, Nic. So yes, I’m David Stockdale, Chief Executive of the British Tinnitus Association, been with the BTA for 12 years nearly now and yeah, really enthusiastic about tinnitus research, finding better ways to manage tinnitus, and ultimately a cure for tinnitus as well so we can deliver on the British Tinnitus Association’s vision of a world where no one suffers from tinnitus.

Nic Wray 1:17
Thank you, David. And Will, would you like to say a few words?

Will Sedley 1:20
Yes, thank you, Nic. My name is Will Sedley, I lead a little bit of a split existence, I spent half my time as a neurologist, not having very much to deal with tinnitus and the other half conducting research into the auditory system, how our brain makes sense of sounds and why we perceive what we perceive with a very particular interest in mechanisms that might go wrong in order to cause tinnitus and other related disorders. I conduct mainly quite small scale studies with human volunteers looking at brain recordings mainly to really try and get at the mechanisms of how tinnitus comes to be perceived as a sound where there is no external sound to begin with what I call the hard problem of tinnitus. And in an ideal world, I’d love to learn everything about tinnitus, there’s a lot I don’t directly cover, but I’m interested in including the myriad ways in which that goes on to affect people’s brains and experiences and functioning and all the other impacts tinnitus has as well.

Nic Wray 2:23
Thank you Will, and finally, I’d like to thank an important organisation that that aren’t here with us, our podcast sponsors Ótologie Tinnitus Care. Thank you very much for your support. So I guess the first question is, what exactly is a biobank?

David Stockdale 2:45
A biobank is in essence, a collection of biological data. And that can then be broadened out as well to not only biological data, and by that we might mean things like blood samples, saliva samples, but also then looking at other broader data as well, which helps us inform and develop and build a picture really to help better understand a condition or impact of different factors rarely in terms of either generating a condition making the condition worse, or also improving as well. And one of the reasons that the British Tinnitus Association are interested in developing a biobank is really through the journey that we’ve been on to really understand tinnitus research, where we’ve got up to, what some of the challenges and barriers are, and how we best respond to them as well. So going through that that journey that we’ve been on in terms of developing a map of tinnitus, if you like, the cure map, so looking at all of the tinnitus research that’s happened, which we then published in a paper called ‘Why is there no cure for tinnitus?’ and then using that to really extrapolate and look at where the challenges are and how can we best address them. And actually, through developing that, through discussions, through arguments, through a lot of different interactions that we’ve had with funders, people living with tinnitus, potential sponsors and the research community, we believe that one of the ways that we may be able to address several of those questions at once is through developing a biobank, a condition specific biobank around tinnitus, to really help us understand those factors and really build on our knowledge and hopefully accelerate our understanding at a pace that we haven’t really seen yet in tinnitus research.

Nic Wray 4:33
As a researcher, Will, do you think that there’s value in it and the need for a biobank? What do you hope it will bring for you?

Will Sedley 4:41
Yeah, I think that’s a really good point and you know is there a need for it? It’s very, it’s very hard to say ‘what is the need?’ Is there a value? Absolutely, yes. I think this, in short, does stand to be very informative in a number of ways about tinnitus. David, I thought it was a really nice summary of what a biobank is and what this biobank would hope to achieve. And I suppose I’d like to contrast it with another really excellent biobank, which you and I have discussed previously, in the UK which is not specifically about tinnitus, but covers an enormous number of health conditions and aspects of health, and collect vast, very, very broad ranging data, everything from blood samples, genetics, measurements, disease, questionnaires, brain scans, etc. And you know, like a tinnitus biobank might these have the strength of having enormous numbers 1000s 10s of 1000s, or even hundreds of 1000s of people, which just give you the numbers to draw robust conclusions about the relationships between all these many, many interacting factors, without which it’s very hard to understand how all these different parts of very complex picture all fit together. And I think one of the things that’s a limitation in something like UK Biobank for tinnitus research is there’s just not enough in there about tinnitus and all the other things that are so important to characterise, to really get a picture about it. So there’s a question or two of whether you experience sound in your ears on a regular basis? What do you think you have a big problem with your hearing, but that’s kind of about it. And this is a real counterpoint, this tinnitus biobank we’re talking about, which will provide a very, very detailed characterisation of – David, you’re probably planning to talk more about this anyway – but a very detailed characterisation of all the really important relative aspects of tinnitus, and related symptoms and risk factors and consequences, without which you just can’t really answer the scientific questions we want to without there being lots of compounds and caveats. One thing that really struck me very early on about this is that it really might help definitively make headway with this very hot topic in tinnitus research that people just aren’t necessarily getting clear answers to. And that relates to subtypes of tinnitus, there’s this big debate of whether there are distinct different subtypes that we really should consider separate conditions and treat as separate conditions, or whether there are lots of ways in which tinnitus varies, each one of which is on a spectrum and there’s just lots and lots of very variable spectra, and you can set it any place in any number of those. And I think without some sort of big resource or biobank, I don’t think we’ll be able to answer those questions. And I think it’s really exciting to be able to actually move forward, I myself have sat on the fence as to whether subtypes of tinnitus really exist or not and I’m looking forward to having the evidence to really push me one way or another.

David Stockdale 7:53
Yeah, and I think just to give an example of something you saying, Will, about the limitations of using UK Biobank for tinnitus research. I remember projects that we were discussing and looking at, you know, could we use the data in a certain way. And actually, because we didn’t even have data on laterality of tinnitus, or whether someone’s hearing tinnitus in the left ear, the right ear or both ears, we felt that we couldn’t really pursue a project using UK Biobank data, which would have helped us with some of that understanding of tinnitus and moving forward. So with those limitations, I think we are really sort of fighting with one arm tied behind our back, I think in using the data that’s out there within existing biobanks at the moment.

Will Sedley 8:34
And then yeah, to come back to the biobank plans for tinnitus biobank that you’ve floated so far, it’s just the richness of the different measures, you know, or detailed characterisation of not only the symptoms, but as far towards objective measures of tinnitus as it exists pitch matching, loudness matching, the different symptom and rating scales, really good characterisation of hearing function in every way possible, examination of all related aspects of physical and mental health consequences of tinnitus and I think, if I’m not mistaken, you’re planning to collect some follow up data so these things can even be used potentially to predict the course of someone’s tinnitus and its impact moving forward, which can be really informative, particularly as the number of treatment options expands, to be able to really know how best to target, which cases to prioritise, which might get better and improved by themselves and what type of approach to use for different cases requiring those interventions.

David Stockdale 9:38
Absolutely, I think it’s right to be ambitious and, you know, obviously constraints of finance and funding come into it, but I think you know, try and do as much as we can, in one go really with one project rather than having to do future longitudinal studies. I think design in as much as you can to ensure that the projects for future proof and collected longitudinal data will certainly be something that we’ll aspire to do.

Will Sedley 10:04
And I guess you don’t necessarily need to bring people back to do the whole shebang and physically attend in person again, but even just catching up over the phone a year or two later, and just checking on the severity of their tinnitus symptoms, as per questionnaires would would tell you so much more.

David Stockdale 10:22
Yeah, absolutely, that’s a great point. So I think yeah, there’s there’s lots of opportunity and ambition there and I think some of it will be trying to navigate that landscape and understand which tests are really going to be optimal in terms of giving us the best shot at finding and uncovering some of those answers that allow others to get involved and really, hopefully pursue that cure and open the floodgates, really, to industry and to researchers to really interrogate and understand what’s there to hopefully help find future potential cures and better ways to manage tinnitus.

Nic Wray 10:58
You’ve spoken a little bit about the type of data that you’ll be collecting and I know plans are at the very, very early stages, but what do you think it would involve, if somebody wants to be part of this biobank? What would you like to see from the tinnitus community in sort of the information that you collect or how they get involved with it?

David Stockdale 11:23
At the moment, we’re designing a collection battery that will take around about two hours because we think that’s the most that we can hope and expect from people rarely to commit to sort of putting themselves through such rigorous testing. And a key tenant of that is going to be getting high quality audiological data, because that’s what’s really lacking in a lot of those existing biobanks at the moment is getting that data around hearing and really thoroughly understanding the interaction between hearing and tinnitus. So a big part of it will be collecting audiological data, we’ll also hopefully be collecting blood samples to continue the excellent work was happened in looking at a better understanding of the impact of different objective markers or biomarkers that may exist for tinnitus, and a whole range of questionnaires as well suggested to understand some basic demographics and some basic history of medical histories of people who are in there, but also then some really specific questionnaires around tinnitus, and probably some mental health questionnaires as well to help us better characterise and understand some of the interactions that seem to occur there. Beyond that, there really is a broad discussion happening about you know, do we need imaging? How can we get imaging if possible, especially within the constraints of how we’re thinking of collecting the data? And also then, you know, looking more broadly as well at tinnitus specific testing or testing that you wouldn’t normally experience within a sort of hearing test, if you like, or an audiology exam. So things like Will mentioned around upper loudness limits and tinnitus pitch matching, and those sorts of things as well and better understanding how they can help us understand and characterise tinnitus and potentially like Will said drop that characterisation that allows us to give a definite type of tinnitus or maybe helped to develop those different categorisations and subtypes of tinnitus as well.

Will Sedley 13:25
I think that’s all really well put. Thank you. And just to pick up on your point about imaging, so for anyone who isn’t clear on that, we’re talking about brain imaging, which is a term that covers everything from very expensive MRI based brain scans to simple things like EEG, ie electrical recordings with little sticky pads placed on the head, a bit like a heart tracing, but on your head, that are very safe and comparatively cheap and straightforward. I think it’s a really key question. I mean, it’s a whole, this is obviously relates a lot to my areas of research. And there’s been decades of interest in brain imaging and tinnitus, and very few, if any, conclusive reproducible findings. And largely because we tend to see a whole series of very small studies with maybe only 20 or 30 people with tinnitus, compared to a control group, often who aren’t matched for even basic things like hearing and sometimes not even age, and trying to make a lot based on them. And the trouble is that lots and lots of small studies never add up to the quality of one big rigorous study. There have been one or two larger ones, even then we’re just talking a few 100 people and still with some caveats. So in a sense, it seems like an amazing opportunity to just go to, you know, 10 or 100 times bigger than anything that’s been done before. I think it’s a challenging thing. Obviously, brain imaging is not absolutely straightforward. It would have to be something very basic like with EEG that’s very portable, cheap and quick to do, there’s still a lot to consider in how one does it. But it’s a big question because I think it comes down to whether the tinnitus is biobank is looking to characterise subtype and prognosticate and follow tinnitus, whether it also wants to in itself, have a shot at uncovering what is the basis or the underlying mechanism of tinnitus, which is still a highly controversial and still rather elusive question without a definitive answer, even now, after the enormous research investment worldwide, that’s gone into tinnitus, I say enormous obviously, it’s another conversation about whether it’s as enormous as it should be, given the incredible scale of the tinnitus problem and I think we all agree, my use of the term enormous here is still an order of magnitude less than we’d like it to be, and less than on a par with other conditions. But it’s not to underestimate the number of minds that have looked at problem in various ways, and still not yet come up with the definitive goods. And I do find this an exciting prospect because I think this very large number of volunteers taking part coupled with a very extensive, broad and rigorous set of tests really will be unique in the field of tinnitus. And I think it’s such a big opportunity to try and make the absolute most of because this does have the potential to move things forward in a way that just hasn’t been possible before.

Nic Wray 16:33
I think that’s a very positive way of looking forward but I think both of you have have mentioned some of the challenges that might be involved in collecting this data and the limitations that there might be, possibly because of funding, because there isn’t the funding in tinnitus research perhaps that there is in other conditions. So what do you think some of the challenges that you’re working on now to overdress of and what could be down the line?

David Stockdale 17:05
There are several, I’ll outline them and then maybe Will you can jump in with with thoughts on on any of them or any I miss too. So, as you say, the biggest is funding, what we’d be looking at would be the largest single tinnitus research project that’s ever been undertaken outside of pharmaceutical research. There’s been a couple of bigger research projects, but they tend to be multilateral with lots of partners and lots of different countries involved. So this would be of a magnitude bigger than anything we’ve seen before that’s been taken outside of industry. And there are other challenges as well. So will people living with tinnitus turn up and and be part and participate and sign up and form an orderly queue to to be part of the project and be part of the biobank. We know that a lot of tinnitus trials in the past have failed on recruitment. No one’s ever tried to recruit to a tinnitus biobank before so there’s definitely a big unknown there. And also, we’ll be relying on getting a lot of people involved who don’t have tinnitus as well, because we’ll need those controls to compare the tinnitus cases with so we’ll want people with very similar hearing profiles, for instance, so that you can compare and contrast and control for differences in hearing. And a further barrier is this is probably a one shot that we’ll get at creating a resource like this, so it’ll be absolutely critical to to futureproof it so we can expand it in different ways if we want to look at different tests or biobanking different samples in the future, as well as wanting to make sure that we collect the best highest quality data to the most rigorous protocols that we can to make sure that the data is usable and isn’t rubbish, you know, you could fall foul of the standard sayings on any database that you get out of it, what you put into it, and unless you’re putting in the best, most robust, highest quality data, then you won’t get the research that you want at the other end of it either.

Will Sedley 19:02
I think those are excellent points, David, thanks. And I would agree on all of them. Although I have a slightly different experience of recruiting to tinnitus research studies in that actually the one the one barrier I’ve never had is a lack of willingness to come forward and take part in research from the tinnitus community. Always been really impressed by just how keen so many people with tinnitus are to get involved. And y ou know, this is in studies where they have nothing directly to gain it’s only just to further knowledge of the field as a whole and out of motivation, like feeling they’re doing a useful and good thing. For my studies, we’ve always paid our participants a modest fee for their time. Many have even tried to refuse to take that. We always insist they do obviously. What is interesting though, is actually that I suppose getting the fully representative sample of the whole tinnitus population out there, because there certainly are certain groups or demographics of people who come forward for research more than others. I think it fundamentally relates to time availability. So we see a big peak in students and we see an even bigger peak in people of retirement age, and then a lower amount in in the middle of people who are very busy with work, young kids, etc, like that, so there may be something to think about, about just ensuring that the sample does remain fully reflective of the absolute breadth of people living with tinnitus, which, as we probably all know, although there is an increasing prevalence of it with age we are really talking about both sexes, all ages, any group of people you care to name really are living with tinnitus in significant numbers. In terms of getting people, David, I think we haven’t so far said that I believe your plan is to load up a van and and one or two trained research technicians, and tour the country, taking in huge swathes of volunteers everywhere you go. That’s still the plan is it?

David Stockdale 21:18
Absolutely, yes. So the plan is still to get a van as you say and equip it with audiological equipments in a soundproof room, and the ability to take bloods and then yes, driving around the country and, you know, located somewhere for a week and get as many people through and processed as possible, and really try and use it as a opportunity to promote what tinnitus is and increase awareness of tinnitus around the UK as well. So that’s, yep, certainly, still the plan. It’s interesting what you say about recruitment as well, because I think something we will want is a representative sample, but we probably will want to skew it towards people who have severe tinnitus, and probably people who are slightly younger as well, so that we can try and get as cleaner medical history, if you like as possible, so that we can rule out as many comorbidities as possible and really try and focus in on that, you know, severe categorisation of tinnitus as well. So see, our big part of our work will be learning from from what you’ve done well in terms of recruitment, as well, and really trying to ensure that we do get samples that are really going to benefit us but as well, of course, we will want the the vast gamuts and spectrum of people living with tinnitus there. So yes, that’s that’s certainly the plan and and the hope is that we can take the van around do huge piece of communications work, really promote where we’re going to be and hope that people will sign up and participate.

Will Sedley 22:48
Great. I find it’s such an appealing prospect, the the touring tinnitus van. And David, it’s very, it’s very important, a serious point you make about the real delicate balancing act, you want, yes, sort of clean are unconfirmed cases without too many other health variables. And you want the severe cases to be able to help them and prioritise them, and enough to really be able to make a lot of conclusions about it. And I guess to some extent, you want enough of the less severe cases, though, so that you have something to contrast the more severe cases with to see the differences. I thought what you said about control volunteers was really important because it is it is generally harder to get the matched controls where you’re you’re constrained in the age, sex and exact hearing profiles and other characteristics of the individual. And yet they don’t have the tinnitus or that thing giving them the reason to be aware of this issue and come forward. So it’s, it’s always doable, but can be a bit more of a challenge. We’ve sometimes ended up needing to pre screen, a larger group of volunteers and then select the best matches. I don’t know whether that’s something feasible for you, or I think you also talked about getting people to bring a friend or bring a family member who you’d hope would be a close match in terms of those variables, which would help help keep things fairly equivalent between the groups you’re comparing?

David Stockdale 24:14
Yes, that’s right. So what we hope would be able to do with the controls is encourage those people who are turning up with tinnitus to, like you say, bring a friend, bring a family member who will hopefully then be closely correlated in terms of some of those variables and help us build a matched database that way and match biobank through, yeah, familiar controls, ideally.

Nic Wray 24:36
So what I’d like to just pop in and say is that if you are interested in this project, and perhaps participating in the future, when it’s when it’s up and running, you can actually sign up on our website, which is tinnitus.org.uk/biobank and there you can also sign up for if you want to learn more more about the project as as it develops. So yes, if you’d like to participate, whether you have severe tinnitus, mild tinnitus, no tinnitus, you’d like to be a control, that will be your opportunity. And I’ll repeat those details at the end of the podcast.

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Nic Wray 25:49
I guess people who are participating, if they have questions about the sort of process and the ethics around the collection, and keeping samples safe, I guess that’s still going to be very key to the success of the project. You’ve talked about the quality of the projects. But I think you would also want to make sure people feel confident in participating. Will what sort of standards do you have?

Will Sedley 26:19
I mean, so thankfully, we live in an era of very closely guarded and controlled research, governance and regulation. So we work under GDPR, the general data protection regulation, which I think people will be familiar with, and have noticed that suddenly every website they use is asking for their permission for every type of data stored. So research data is the research that is the most tightly controlled. There’s very clear and strict regulation, that we have to store the minimum amount of sensitivity of data and it to be as unpersonally traceable as possible, which is what would, in the unlikely event of a data leak, minimise any impact. And I think we’re not talking about data with the potential for exploitation, like bank details, financial records and things. But still, it’s a very high priority to guard this. And then there are mandatory systems in terms of where the data can be stored, you know, physical records needing to be locked away with controlled access only to people who are members of the research team and need to access them and only for that purpose, digital records, which we’re mainly talking about being stored on secure servers, password protected, and again, viewed and analysed only by people who have a need to look at thema nd only for those purposes. We often use additional anonymisation procedures. So although we may have the actual name and identifiable information of the person who signed up for the purposes of contacting them, and booking them in, often when they actually enter the study, everything is just recorded under a random or otherwise identifiable anonymous code. And you may have a single piece of paper in a locked filing cabinet somewhere that links the code to the individual. And at the end of the study, there’s a time even that’s destroyed. And you can never link the data to the individual so that they’re all these layers of security. So it’s it’s almost something that, yeah, it’s so important that I think we in the research community almost just can take it as read that it will happen, and we’ll follow that. But I think it’s an important thing to emphasise here that people’s information and data security are taken very seriously. But, David, you can probably comment, I suspect you may have thought more about the specifics of how this would actually run for the tinnitus biobank.

David Stockdale 28:42
Yeah, and I think that’s a great description you’ve given there Will of how it is ran within the university and a key part of what we’ll be doing is working with a university partner to run through their ethics systems to ensure that we are doing their, you know, best practice levels and best governance levels to ensure that we do have the right data compliance and that it is excellent as well, I mean, we will face some challenges with doing it in terms of will be potentially collecting the data out in the field continuously. So again, we’re thinking about how to make sure that that data is transferred ethically and quickly and that as little data as possible is maintained on site if you like or within the IT systems that may be in the van so uploading the data every evening to a central site and then erasing the data from the from the local sites or other the IT that we have to collect the samples will be really key. So yes we’re looking at all of that as well as obviously what happens to the blood samples as well. So we’ll be sending off the blood samples that are collected on a daily basis as well to ensure that they’re stored in the right way, both for security but also to to preserve the blood as best as possible.

Nic Wray 29:56
I think you’ve both spoken about things like collecting the best data, following the best practices, the sort of focus on quality here seems really, really key. Are you hoping that the studies that come out using this data will be equally robust? And will this data be open to researchers to use in the future?

David Stockdale 30:23
Yeah, of course, you know, again, you only get out of it, what you put into it. And I think a really big part of the BTA’s work whilst this is going on, and whilst the research whilst we’re collecting the data, will be really to motivate the tinnitus research community and wider afield to use and access this data as well and to look at what we can learn. And even maybe using things like informatics and big data systems and algorithms as well to really interrogate it and see what we can learn. So I think yeah, we will absolutely be focusing on that high quality data as well. And you know, the reason for doing this is it’s very easy to collect abstract bits of data on tinnitus at the moment. I mean, you know, the BTA we do very well in terms of sending out questionnaires and getting people to fill it in there and then. What’s missing is this high quality healthcare data link to it, and specifically the audiological data, in my view. And so being able to have that match that all together is what’s going to give us those answers. But then, yes, we need a motivated enthused inquisitive researcher community to work with us to really find those bits of gold, those golden nuggets that are going to help us move the field forward, and really help us to understand, you know, where the opportunities lie for future treatments and hopefully, future cures.

Will Sedley 31:46
And just to run with what you’re saying, David, which I think was really well put, I think part of the original thing you envisaged right from the start is not merely that these data would be available on request to other tinnitus researchers in groups, but reaching out to these groups, collaborating with making the data available, and then applying their own ingenuity techniques, was one of the massive intentions right from the outset, that again, while you might have questions you’ll be able to address directly from the plans you already have and the data that actually seeing what everybody else in other groups can make of them was a real part of the value you’d anticipate from the project. And I think that’s still still the case, isn’t that?

David Stockdale 31:49

Will Sedley 31:51
There’s certainly no shortage of creativity in the tinnitus research community about the different analytical techniques people are keen to try on datasets. It never ceases to amaze me. I think you’d also mentioned one possible way of this a§lso feeding into the activities of the wider tinnitus research community was whether it could also serve as providing pools of people who might be interested in participating in other research studies, presumably people when they signed up would give their consent that yes or no, I don’t do or don’t want to be contacted by other researchers to let me know of other research studies. But if they did, it would mean that other research studies could be run on very, very robustly well characterised, well studied tinnitus populations. Because I think often a lot of brain imaging, for instance, studies of tinnitus, they do great brain imaging, but they haven’t spent the hours and done the meticulous work in characterising people’s details, symptoms, hearing profiles, medical histories and all the other bits. And then actually, combining the best of both worlds might might really increase the quality and rigor of studies because it is very well identifying some change in the brain, whether it’s a change in brain structure, function connectivity, or how the brain responds to sound, for instance, you need to know exactly what you’re correlating it with. And if you know exactly what you’re correlating it with, because you’ve really carefully controlled your groups and you’ve matched them for everything and the only difference is the tinnitus or this one variable in tinnitus, then you can make sense of those brain data. And one thing that’s just so frustrating continually reading tinnitus research papers is these studies come out and go ‘Oh, we found these and these and these brain changes’, but the groups, there are so many differences between the tinnitus group and the control group, even simple things like age and hearing if those are controlled for, there are differences in things like overall levels of distress, arousal, sleep disturbance, possibly medications, although usually controlled for, just even what kind of study they know they’re taking part in, how they’re deploying their attention. So so many other factors, and I think I do see potentially a tinnitus biobank, again being able to help kind of close some of these holes in the field and really allow us to be much more robust in interpreting our findings. Of course, it does require having the people willing to come back for these studies and the research groups motivated to contact people and run the studies, bearing in mind that of course, the people will be scattered around the country. And any, for instance, brain imaging study or further research would be located in one geographic area. But I suppose you’d be presumably hoping to have – because there’s so many people you hope to have involved in tinnitus biobank – that actually, even in any given geographical area, that would still be a bigger number of individuals than most research studies in tinnitus, even just in that one area. Is that right?

David Stockdale 35:29
Yes, I think so. As you say, one of the added value projects of this I hope that we will be able to do is generate a patient registry. So a register of people who are, like you say, very well characterised, if we can link their data to their records as well saying that, you know, they’re willing to be part of tinnitus trials, anywhere. And then yeah, the hope is that, again, research centers will be able to come to us and say we want, you know, this characterisation, we’ll be able to tell them how many there are within their centre, or within 100 mile travel radius, or whatever else, and be able to, you know, really help with with some of the recruitments with some, you know, like you say, exceptionally well characterised data. And yes, because of the numbers that we’re looking to recruit, I’d expect there’d be, you know, mid low to mid hundreds in any city in the UK, which again, you know, compared to what happens with most studies, especially those around imaging, like we’ve already discussed, it’d be an order of magnitude above what’s been achieved in the past.

Will Sedley 36:28
Yeah, I think it’s fantastic. I think this could be so… I’ve got progressively even more enthused about this side of the benefits of the biobank, potentially, as time has gone on.

Nic Wray 36:39
So as well as this sort of almost side effect and increasing collaboration within the tinnitus community, is there a sort of main aim of the biobank that we haven’t yet talked about, that you’d like to sort of explore and discuss.

David Stockdale 36:58
I think it doesn’t have one aim, I think it has several, you know, around can we find an objective measure? Can we find a biomarker? Can we better define tinnitus? Can we, you know, look at those subtypes, which is probably you know, where we will have most success, I think, with this and looking at identifying if subtypes do or don’t exist within tinnitus. But then beyond that, there are so many other projects and points that we could find and add value around as well, in terms of, you know, looking specifically around comorbidities and their interactions with tinnitus, that, you know, haven’t had the data to really go to the levels that we’d be able to with the depth of information that we’ll have on tinnitus and the audiological data as well. So I think there are real opportunities to do that and maybe start to untangle the hearing tinnitus challenge as well, in terms of you know, what confounds the other? And what are the real impacts of hearing loss and tinnitus? And how do you like, say, start to entangle those because once we do that, it really does open the doors, I think, as well for for future drugs trials as well. If you look at the drug trials that are happening at the moment, there are lots of them focused around hearing, restoration, or hearing recovery. And actually, will those help tinnitus or not? We don’t know. But actually through this, we might be able to understand if they could or if not, why not as well. So I think there’s some real exciting tangents off those main core questions as well. I mean, if we’re successful in answering any of those core questions around subtyping, you know, objective measures, even finding the optimal subjective measure, you know, it’ll help tinnitus research move forward in the future as well.

Will Sedley 38:43
Absolutely, fully agree on all accounts. And I think to to again, run further, I think there’s sort of two points I can raise here. I think on the one hand, I think a project of this kind, sometimes the most exciting and useful things that come out of them aren’t even the ones you initially planned because you learned so much that until you learned it, you didn’t even know what were the right questions to ask. But I think on the other hand, absolutely, there are some clear, tangible goals and very likely gains that we could be confident would come out of it. And I fully agree I think the lowest lying fruit of the major tinnitus questions will be the subtyping. And it’s really not to be underestimated the importance of this. It generates so much debate and many consider it a critical barrier to progress in the field. I think with a brain imaging measure, if able to get it in there, there could be, whatever that measure is, this may prove to be THE overwhelmingly most definitive study to date on what the best biomarker or measure of or abnormality have related to tinnitus or causing tinnitus is, as long you know, provided it’s detectable with that measure. If you measure ongoing resting state brain activity, it may be the definitive tinnitus resting state brain imaging study, if you look at responses to sounds that may be the definitive sound response brain imaging study. Now, it’s still unclear whether any of those techniques can reveal the basis or the biomarker for tinnitus. I think to really understand tinnitus, you have to understand all the complexities of how perception in general works in the brain. And that’s an incredibly multifaceted and subtle area. But I think there is a really significant chance of real progress here if the brain imaging measures are there. And then yeah, absolutely, even if they’re not, you know, then they use as a resource to feed into and just massively bolster the quality of and recruitment into a range of other research studies going on nationwide, I think could be immensely helpful.

Nic Wray 40:49
So this, you feel is going to be a real step change in tinnitus research, it sounds as if it’s got the potential to really influence very widely, all the research activity possibly that’s that’s going to be undertaken.

Will Sedley 41:07
Yeah, I think potentially, yeah. So if you imagine as an example, you know, if I run a research study with even say, you know, 60 people, 30 with tinnitus and 30 without, up in Newcastle, and someone else runs one in London, and someone else runs one in Nottingham. Even if we try and, you know, we’ve all got our own interests say one of us is using EEG, another using magnetic responses, another using FMRI and another’s using structural brain scans. And we want to compare the results of these to each other. We may find even if we’ve set out trying to all study tinnitus, we’ve all recruited slightly different groups of people through different means. Mine might have a lower level of mean distress, because I don’t get them through hospital clinics and someone else might get them through clinics and have had people with high levels of distress, might be different hearing profiles, we may make different measures of people’s hearing and their audiograms and tinnitus characteristics, we will assess them in different ways. And so actually, by the time you then, even before you get into comparing the different measures we’re making, we may well be looking at fundamentally different groups or subtypes or categories of people with tinnitus. So I think one way I think as David’s very rightly been thinking, if this biobank is established, and we’re able to go: well, okay, I can define exactly this point in this category of people with tinnitus, who have aged between this range, tinnitus distress between this range with these audiometric characteristics and these masking level functions and everything, suddenly, we don’t all have to reinvent the wheel and try and recruit a tinnitus population and all do it differently, we can very easily get truly equivalent populations, just by selecting from a predefined list, not to mention save an enormous amount of work in the process, which is a very large part of researchers’ time, just in recruiting and finding the right people. So I think it’ll definitely help but I think, you know, just because of that close, much more closer matching and real, you know, being been able to have consistent representative populations, I think, you know, we maybe could rightfully call it a potential step change in tinnitus research.

Nic Wray 43:22
I think one thing I’m picking up from both of you is that although the idea sounds very abstract, and how is it related to actually helping people with tinnitus in the here and now, is actually going to be a really practical resource and a very functional resource?

Will Sedley 43:44
I think it is very practical, and it’s a good point, and you need to remind us, you know, particularly people like me in the research community, yes, you know, it easily can feel like a separate issue to actually just get on and curing tinnitus. But the trouble is, you know, broadly speaking, the reason we can’t yet cure tinnitus is we don’t truly understand the mechanisms of tinnitus. And I think there’s been misplaced optimism about tinnitus cures for a long time now. So a few years back talking to a number of eminent tinnitus researchers, they were reminiscing, saying, well, 10 years ago, we had a big annual tinnitus conference, and the question was openly asked, when are we going to get a tinnitus cure? And the most pessimistic figure given was 10 years. And when we’re having this discussion now 10 years had passed and there was no tinnitus cure. And, you know, I am optimistic we will eventually get there. I’m still not sure how, what it will look like when it will be discovered how we discovered but I think it’s, unfortunately naive to rush straight for the cures and the treatments, I mean, there’s always a chance it works, but what really has the chance of getting us there is knowing exactly what we’re treating, what are the markers, what are THE core mechanisms, we need to get in there and modify. And this kind of research of really robustly characterising tinnitus, getting rid of all the caveats and the confounds and the roadblocks holding up progress is such a necessary step. And I think then you know, that these steps that will move us towards the treatments, and eventually the cures will follow on.

David Stockdale 45:25
So, I think this responds to some of those points. So whilst it can feel like we’re taking a step back, there were three big tinnitus drugs trials that happened. I think that the last one reported in around 2018/2019, and they all failed. But what was really different this time was that a lot of the companies talked about why they failed and what they saw as the shortcomings in research. And this project really is a response to those. So things like you know, the lack of adequate measures, the lack of a way to effectively target a population within the tinnitus population to trial a drug on, the fact that, you know, they couldn’t actually properly measure tinnitus, start and endpoint, to see what the change was, you know, these, these were really big issues that they’ve raised alongside things like, you know, the translational research and the fact that, you know, these research projects had done so well in animal models, but then didn’t go into clinical models and didn’t pass muster once they were in human trials. And so these huge issues were raised by pharma companies at the time, and this study is part of trying to address those to help build those blocks so that drugs trials in the future do have the greatest chance of success.

Nic Wray 46:43
Thank you, David. And I guess, what are the next steps in this project? And what would you like to see happen?

David Stockdale 46:53
So from here, it is about getting together a scientific board, to look at really starting to develop the protocol and put some meat on the bones really, of, you know, what tests and how and check that, you know, what we’re proposing would be acceptable to people living with tinnitus, as well, that they would actually turn up to a van on a cold day in Stoke or something and, you know, sit in there for a couple of hours and do those tests. So, you know, we’ve got to do that side of it. But as well, a big part is going to be, you know, getting the fundraising going as well, this is going to be the biggest ever research projects, as I said, that’s happened, certainly, that’s been delivered by the BTA be it in partnership with others. So again, you know, it will be about getting that income and getting the money in to make sure that we can make this happen and make it a reality, as well as you know, doing what we can to develop the project alongside that and develop the protocol and hopefully pilot it as well.

Nic Wray 47:49
Fantastic. And I mentioned earlier that people can get involved by signing up at tinnitus.org.uk/biobank so that they can register an interest in participating once it gets underway, or finding out a little bit more about what biobank is and how the proposals are. If people have got any questions about what they’ve heard on the podcast, they can also submit a question because we’ll put an FAQ together from that, so that they can find out more as well. And that’s at tinnitus.org.uk/tinnitus-week-podcast-2022

David Stockdale 48:33
Can I just add a little bit Nic, just to say, you know, I’m really excited by this project and incredibly passionate about it, I do think that where we are at the moment as a research community, as a patient community, this makes a lot of sense to try a project like this to see if we can take it forward. And I’m really optimistic about what it will produce as well. So I just, you know, emphasise the point you made there to people listening to this, please engage with us, get involved, send us your thoughts, you know, what do you think, you know, is this a goer or what else have we missed? What do you think we should be looking at? Because, you know, I think we’re really looking for this to be a community project as well. And something that is owned by the tinnitus community so yeah, get involved and join in the debate on how we should do this and take it forward.

Nic Wray 49:21
Fantastic and Will, are you as excited about the project as David is?

Will Sedley 49:26
Very much so yes, I won’t restate his level of excitement other than to say, I agree on all fronts, and I share his level of enthusiasm.

Nic Wray 49:37
That’s fantastic. I think we will probably draw this to a close now. So it just remains for me to thank Will Sedley, thank David Stockdale, thank our sponsor, Otologie Tinnitus Care, and just remind people again, if you’d like to participate, it’s tinnitus.org.uk/biobank and if you’ve got any Questions for us that we can use for our FAQ, tinnitus.org.uk/tinnitus-week-podcast-2022. Thank you very much.

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