Randomised controlled trial of interventions for bothersome tinnitus: Desyncra^TM versus cognitive behavioural therapy

Abstract

Objective

Compare the relative efficacy of Desyncra^TM and Cognitive Behavioural Therapy (CBT).

Design and study sample

Sixty-one participants were randomly assigned to receive either Desyncra^TM (n = 29) or CBT (n = 32). Randomisation included stratification regarding current hearing aid (HA) use. Depending on group assignment, participants attended approximately 7–12 visits. Tinnitus distress was measured using the Tinnitus Questionnaire (TQ).

Results

Mean TQ scores decreased post-baseline from 5–15 points across treatment arms and strata. Model-based findings for the no-HA stratum showed a difference of −2.0 TQ points favouring Desyncra at 24-weeks, with a 90% posterior interval varying from −5.4 points favouring Desyncra to 0.8 TQ points favouring CBT. For the HA stratum, results show a difference of −1.0 TQ points favouring Desyncra, with a 90% posterior interval ranging from −4.7 points favouring Desyncra to 2.9 points favouring CBT.

Conclusions

The difference between Desyncra and CBT on average showed greater improvement with Desyncra in the no-HA stratum by about 2 TQ points. To the extent that the study sample represents a clinical population and recognising the assumptions in the design and analysis, these results suggest Desyncra is just as effective or more so than CBT in reducing tinnitus distress.

Keywords:

• Tinnitus
• randomised controlled trial
• Bayesian analysis

Disclosure statement

The authors SMT, GPM, CJS, SMD, MG, RQL, CR, and JAH declare no conflict of interest, but want it to be on record that the funder of this study manufactured the device evaluated for efficacy in this study. Once agreement was reached as to study design, all study procedures and data analyses were conducted independent of company influence. Co-author CH was affiliated with Desyncra Operating GmbH, a company linked to the funder of the trial Desyncra Inc., between 2015 and 2019. CH contributed to study idea and conception, study protocol, training and support during study conduct. CH was not involved in study conduct and data analysis. These contents do not represent the views of the U.S. Department of Veterans Affairs, Department of Defense, or the United States Government.

Additional information

Funding

This material is the result of work supported with resources and the use of the facilities at the VA RR&D National Center for Rehabilitative Auditory Research (VA RR&D NCRAR Center Award; C2361C) at the VA Portland Health Care System and the RR&D Research Career Scientist Award to Dr. Henry (C9247S).