A Randomized Single-Blind Controlled Trial of a Prototype Digital Polytherapeutic for Tinnitus

[Damocles]

I'm afraid it's not a good study. The results are basically the same as for most other trials so far, regardless of which treatment is being tested: Success is claimed based on some marginal improvement as measured through a self-assessment survey (THI, TFI, etc.) with a random threshold for 'clinical significance'.

Thank you for the breakdown @Hazel, as, to be honest, I didn't read much further than the two paragraphs beyond that exciting headline.

Put that down to disinterest really, as my take here is/was: if any auditory stimulus is going to be effective, it's going to be effective only when coupled with electrical stimulation (yes I'm talking about the Shore device).

So if the University of Auckland is telling me "damn, people are feeling gooood after listening to this sound we generated on their cheap tinny phone speakers", then my first though is "damn, when you add 20 years of research into signal timing to the mix, those people are going to feel REALLY goooood".

But as you say, just more of the same. Another sound therapy app to add to the list of 9000 sound therapy apps you can choose from. More self-reporting, with the researchers probably playing some sort of elaborate game of charades with the participants over the table, in an effort to have them report the most impressive looking results.

As far as I'm concerned, Shore's head zapper is last chance saloon for anything involving sound therapy. And if that doesn't work, I don't want to hear another thing about that approach as a tinnitus treatment again.

 

[ZFire]

But as you say, just more of the same. Another sound therapy app to add to the list of 9000 sound therapy apps you can choose from. More self-reporting, with the researchers probably playing some sort of elaborate game of charades with the participants over the table, in an effort to have them report the most impressive looking results.

 

[UKBloke]

Anyways, no point of discussing this more.

I disagree. I think it's hugely important to keep discussing this, but I think we need to help tinnitus researchers in their various establishments shift the focus from self-reported patient outcomes to objectively measurable ones.

 

[ZFire]

I disagree. I think it's hugely important to keep discussing this, but I think we need to help tinnitus researchers in their various establishments shift the focus from self-reported patient outcomes to objectively measurable ones.

Agreed. Precise measurements should be a main priority at this point. Objective measurements will make evaluations of potential tinnitus treatments more simple to determine.

Let's hope the Bionics Institute can deliver the goods.

 

[ThomasF]

The attempts at pharmaceutical or even mechanical aids to fix tinnitus and its causes are much more my speed. Sound therapy seems like the thinnest barrier of entry and it's been done to death. They've figured out pharmaceutical solutions to conditions like epilepsy and PBA. There is likely one for the brain based part of tinnitus. Fixing the ear, cochlea, and its associated tissues has got to be in the cards.

I don't want to sound ungrateful for the attempt, I just want to put my emotional energy into stuff that actually wants to "fix" the problem and not cover it up.

 

[GeorgeLG]

The attempts at pharmaceutical or even mechanical aids to fix tinnitus and its causes are much more my speed. Sound therapy seems like the thinnest barrier of entry and it's been done to death. They've figured out pharmaceutical solutions to conditions like epilepsy and PBA. There is likely one for the brain based part of tinnitus. Fixing the ear, cochlea, and its associated tissues has got to be in the cards.

I don't want to sound ungrateful for the attempt, I just want to put my emotional energy into stuff that actually wants to "fix" the problem and not cover it up.

My wish is that, for you and other like-minded people, the research community is able to deliver a pharmaceutical solution for you. I don't have the luxury of time and for me personally, I take almost no medicines and prefer it that way. For these reasons any relief I can find, anything that gives me more good days now is my goal. I hope we all find what we're looking for.

George

 

[Faff]

Searchfield's been working on this sort of thing for a while. Even if it ultimately ends up being little more efficacious than other options, I appreciate the push towards more personalised therapies and more accurate tinnitus avatars. With any luck the theories explored in this kind of work can be used to greater effect in combination with other approaches down the line.

I found his contributions to The Behavioural Neuroscience of Tinnitus quite interesting and if I recall correctly Searchfield's clinic has some ongoing research around more accurate measurement beyond self-reporting too, so I hope it all bears fruit. If I manage to get in the same room as him this year I'll certainly ask about it.

The sensational headlines about an app are pretty frustrating though.

 

[Nick47]

We are very close to relief and should cherish all the opportunities that can help us.

@InNeedOfHelp, I just can't feel your optimism. We are clinging onto Dr. Shore's device. If this silly mobile app is cited as a 'breakthrough cure' by ScienceDaily, then it's ridiculous. It's about as much use as a Lenire. These products have some big financing behind them to throw them into mainstream but are generally a pile of bollock$.

 

[Fightthearmy]

I'm afraid it's not a good study. The results are basically the same as for most other trials so far, regardless of which treatment is being tested: Success is claimed based on some marginal improvement as measured through a self-assessment survey (THI, TFI, etc.) with a random threshold for 'clinical significance'.

A 13-point reduction in TFI (the 'clinical significance' threshold) essentially means being somewhat less bothered. This result can and has been achieved many times by any kind of intervention; it's a combination of placebo, natural improvement, and patients responding to getting a lot of personal attention from clinicians. Who knows how these patients will be doing a year or so later; that almost never gets measured.

It also matters what you compare your treatment against. They chose white noise, which in my view is one of the poorest forms of sound therapy (compared to for instance amplitude modulation or notched music), so not exactly a fair comparison. Even so, the paper shows that the TFI decreases for both treatment and control almost at the same rate, and the slight difference between treatment outcomes is not statistically significant. So essentially, the authors themselves are stating that their treatment is just as good/bad as white noise.

A proper control group, one that gets no intervention whatsoever, would have helped strengthen the statistics (but perhaps not in favour of the study). And of course, TFI is a poor outcome measure compared to minimum masking level or similar.

That said, it is at least an RCT-like study, with reasonable sample size; I've definitely seen much poorer study design in tinnitus. And at least they didn't select any patients who've had tinnitus for less than six months. But when it comes to outcomes, this is really is nothing we haven't seen before, and quite astounding to see it being marketed as a "breakthrough" and "cure" by ScienceDaily.

I do appreciate OP for trying to see a silver lining, and I'm not saying tinnitus research is all bad. But it's important that we, as a community, are critical of study design and especially of how study results are communicated. Reading the ScienceDaily article versus the actual paper it's hard to believe they're talking about the same study!

It is a good study. It shows that it does not work.

 

[Joeseph Stope]

Agreed. Precise measurements should be a main priority at this point. Objective measurements will make evaluations of potential tinnitus treatments more simple to determine.

Let's hope the Bionics Institute can deliver the goods.

I'm also hopeful about this new avenue. It might expand our knowledge of what influences tinnitus long-term.

Or what are the things that have the worst effect on tinnitus. Loud noise, flu, COVID-19, the various pharmaceuticals.

It might even throw light on hyperacusis, e.g., using long-term comparative studies.

Kind of like gallows humour. The scientists tell us after all the millions of man-hours and $ in research: "Like, we think we know what it is, we don't know how to cure it, but boy we sure can tell you if you've got it and we can even measure it..."

 

[Nick47]

The attempts at pharmaceutical or even mechanical aids to fix tinnitus and its causes are much more my speed. Sound therapy seems like the thinnest barrier of entry and it's been done to death. They've figured out pharmaceutical solutions to conditions like epilepsy and PBA. There is likely one for the brain based part of tinnitus. Fixing the ear, cochlea, and its associated tissues has got to be in the cards.

I don't want to sound ungrateful for the attempt, I just want to put my emotional energy into stuff that actually wants to "fix" the problem and not cover it up.

THIS. Yes, I was thinking sound therapy has had its day. People with reactive tinnitus, hearing loss and hyperacusis are hardly jumping for joy when they hear sound therapy. It's either restore auditory input, which in the near term (<10 years) can only be achieved through technology, not regeneration, or modulate the brain with pharmaceutical or electrical modulation. Any new invention or trial playing sounds (for me) gets brushed aside.

I was listening to a BBC interview from 2008. Dr. De Ridder was implanting electrodes (sometimes successfully) back then and Berthold Langguth was doing TMS.

BBC: Longing for Silence

So to move forward 15 years and have studies on sound therapy is retrograde, like a dial up modem.