NCT04663828: UNITI-RCT

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

Completed NA Last updated 14 August 2023

What this trial tests

NA trial testing Structured counseling in Tinnitus in 500 participants. Completed in 15 June 2023.

Timeline

16 April 2021

Primary endpoint
19 December 2022

15 June 2023

Quick facts

Lead sponsor	UNITI Consortium
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	500
Start date	16 April 2021
Primary completion	19 December 2022
Estimated completion	15 June 2023
Sites	1 location across Germany

Drugs / interventions tested

• Structured counseling
• Hearing aids
• Cognitive behavioral therapy
• Sound therapy

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

UNITI Consortium

Who can join

Adults 18 to 80, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial.
   Schoisswohl S, Langguth B, Schecklmann M, Bernal-Robledano A, et al · · 2021 · cited 18× · PMID 34863270 · DOI 10.1186/s13063-021-05835-z
2. Development of Machine-Learning Models for Tinnitus-Related Distress Classification Using Wavelet-Transformed Auditory Evoked Potential Signals and Clinical Data.
   Manta O, Sarafidis M, Schlee W, Mazurek B, et al · · 2023 · cited 8× · PMID 37298037 · DOI 10.3390/jcm12113843
3. Understanding tinnitus symptom dynamics and clinical improvement through intensive longitudinal data.
   Engelke M, Simões JP, Basso L, Wunder N, et al · · 2025 · cited 3× · PMID 39809918 · DOI 10.1038/s41746-024-01425-w
4. Single versus Combination Treatment in Tinnitus: An International, Multicentre, Parallel-arm, Superiority, Randomised Controlled Trial
   Schoisswohl S, Basso L, Simoes J, Engelke M, et al · · 2024 · cited 2× · DOI 10.1101/2024.01.09.24300978
5. The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).
   Simoes JP, Schoisswohl S, Schlee W, Basso L, et al · · 2023 · cited 2× · PMID 37488627 · DOI 10.1186/s13063-023-07303-2
6. Single versus combination treatment in tinnitus: an international, multicentre, parallel-arm, superiority, randomised controlled trial.
   Schoisswohl S, Basso L, Simoes J, Engelke M, et al · · 2025 · cited 1× · PMID 41271763 · DOI 10.1038/s41467-025-66165-1
7. In Silico Clinical Trials in Drug Development: A Systematic Review.
   Chen B, Schneider LC, Röver C, Comets E, et al · · 2026 · PMID 41284211 · DOI 10.1007/s43441-025-00893-w
8. Loss of function and structural variants in the <i>PRKRA</i> synaptic gene link mild cognitive impairment and tinnitus
   Pham MT, Bernal-Robledano A, Escalera-Balsera A, Schoisswohl S, et al · · 2025 · DOI 10.1101/2025.11.04.25339446