UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)

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).

Conditions

• Tinnitus

Interventions

OTHER

Structured counseling

Structured patient education and counselling is considered as providing information to patients in order to empower them to better manage their disorder

DEVICE

Hearing aids

Hearing aids are considered medical devices and are recommended to patients with a certain degree of hearing loss. Hearing aids amplify environmental sounds.

OTHER

Cognitive behavioral therapy

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

OTHER

Sound therapy

Several sounds and music are used for tinnitus disorder

Sponsors & Collaborators

• University Hospital Regensburg

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital Clinico Universitario San Cecilio

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• UNITI Consortium

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-16

Primary Completion

2022-12-19

Completion

2023-06-15

Countries

• Germany

Study Locations