At a glance
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UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)
In Brief
A clinical study evaluating Structured counseling, Hearing aids, and 2 other interventions for Tinnitus. Completed, enrolled 500 participants across 1 site.
Detailed Summary
The study includes a 12-week treatment trial for chronic tinnitus patients using 4 different types of interventions (hearing aids, sound therapy, structured counseling, cognitive behavioral therapy) either as a single treatment or a combination of two treatments. There are several aims of the study: compare 1) single vs. combined treatments, 2) single treatments vs. other treatments, 3) ear and brain based interventions, 4) analyzing data of the clinical trial in combination with other recorded data (genetic and proteomic data, audiology data) to develop in silico models of tinnitus and a decision support system with the aim to aid in treatment decisions. This randomized controlled trial is harmonized over five clinical centers in Europe with the aim to include 100 patients per center and is part of the UNITI-project (UNification of treatments and Interventions for TInnitus patients) funded by the European Union's Horizon 2020 programme (grant agreement number 848261).
Study Details
Timeline
Interventions
Structured patient education and counselling is considered as providing information to patients in order to empower them to better manage their disorder
Hearing aids are considered medical devices and are recommended to patients with a certain degree of hearing loss. Hearing aids amplify environmental sounds.
This is a structured intervention and consists of a several week program both with noise exposure and structured interviews and expert-patient as well as patient-patient interaction in groups
Several sounds and music are used for tinnitus disorder