Ear ringing got you spinning? Scientists develop a breakthrough tinnitus treatment
In the most basic sense, tinnitus can be defined as ringing in one or both of the ears. It fills your ears with sounds such as ringing, buzzing, hissing, chirping, whistling, or other sounds out of nowhere. Though it's not classified as a disease, it can be an indicator of various health conditions.
There is not yet a specific treatment method for tinnitus. Often, it remains uncured, but there are some ways that are used to ease the symptoms. Now, researchers from the University of Auckland in New Zealand have come up with "encouraging results" from a clinical trial of a mobile-phone-based therapy, according to a press release published by the institution.
A prototype 'digital polytherapeutic'
In the study, the subjects were randomly assigned to two treatment methods. The first was a prototype of the new "digital polytherapeutic" while the second was a popular self-help app producing white noise. The results demonstrated that the 31 people who went through the polytherapeutic treatment showed noteworthy improvements in 12 weeks while the other group of 30 did not.
The new therapy is an initial evaluation by an audiologist who develops a personalized treatment plan using a variety of digital tools based on the patient's tinnitus experience. "This is more significant than some of our earlier work and is likely to have a direct impact on future treatment of tinnitus," said Grant Searchfield, an Associate Professor in Audiology.
"Earlier trials have found white noise, goal-based counseling, goal-oriented games and other technology-based therapies are effective for some people some of the time," said Dr. Searchfield. "This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control."
As explained in the press release, this therapy rewires the brain so that the tinnitus sound is reduced to a background noise with no significance or importance to the patient.
"Sixty-five percent of participants reported an improvement. For some people, it was life-changing - where tinnitus was taking over their lives and attention," said Audiology research fellow Dr. Phil Sanders. He further states that seeing his patients' distress and having no effective treatment was what inspired his research. "I wanted to make a difference."
The next step of the research team is to extend their clinical trials in order to achieve FDA approval. They hope to make the application clinically available in around six months.
The results of the study were published in the journal Frontiers in Neurology.
Objective: This randomized single-blind controlled trial tested the hypothesis that a prototype digital therapeutic developed to provide goal-based counseling with personalized passive and active game-based sound therapy would provide superior tinnitus outcomes, and similar usability, to a popular passive sound therapy app over a 12 week trial period.
Methods: The digital therapeutic consisted of an app for iPhone or Android smartphone, Bluetooth bone conduction headphones, neck pillow speaker, and a cloud-based clinician dashboard to enable messaging and app personalization. The control app was a popular self-help passive sound therapy app called White Noise Lite (WN). The primary outcome measure was clinically meaningful change in Tinnitus Functional Index (TFI) between baseline and 12 weeks of therapy. Secondary tinnitus measures were the TFI total score and subscales across sessions, rating scales and the Client Oriented Scale of Improvement in Tinnitus (COSIT). Usability of the US and WN interventions were assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ). Ninety-eight participants who were smartphone app users and had chronic moderate-severe tinnitus (>6 months, TFI score > 40) were enrolled and were randomly allocated to one of the intervention groups. Thirty-one participants in the USL group and 30 in the WN group completed 12 weeks of trial.
Results: Mean changes in TFI for the USL group at 6 (16.36, SD 17.96) and 12 weeks (17.83 points, SD 19.87) were clinically meaningful (>13 points reduction), the mean change in WN scores were not clinically meaningful (6 weeks 10.77, SD 18.53; 12 weeks 10.12 points, SD 21.36). A statistically higher proportion of USL participants achieved meaningful TFI change at 6 weeks (55%) and 12 weeks (65%) than the WN group at 6 weeks (33%) and 12 weeks (43%). Mean TFI, rating and COSIT scores favored the US group but were not statistically different from WN. Usability measures were similar for both groups.
Conclusions: The USL group demonstrated a higher proportion of responders than the WN group. The usability of the USL therapeutic was similar to the established WN app. The digital polytherapeutic demonstrated significant benefit for tinnitus reduction supporting further development.